Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: st jude medical fortify st implantable cardioverter defibrillator
the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning fortify st implantable cardioverter defibrillator (icd) models [cd1235-40, cd1235-40q, cd2235-40 and cd2235-40q], manufactured by st jude medical.
the merlin pcs programmer software model 3330 versions 14.2.2, 16.2.1 and 17.2.1.1 provide new features for st. jude medical pacemakers, icds and crt-ds, including an option to enhance the st diagnostic features in st. jude medical fortify st icd models cd1235-40, cd1235-40q, cd2235-40 and cd2235-40q via a device software upgrade. during a device software upgrade, implanted devices are temporarily placed into the back-up pacing (bvvi) and back-up defibrillation only (bdfo) mode. the back-up mode parameter settings will be in effect for the two minute upgrade process. once the upgrade successfully completes, the device will revert to the previously programmed parameter settings. the safety alert is being provided to ensure that the operation of these devices during backup operation is clearly understood. depending on the individual patient, this temporary change in parameter values could make the device susceptible to over-sensing and potentially deliver high voltage therapy during the upgrade procedure.
in order to prevent the potential for inappropriate therapy during the software upgrade process, the manufacturer advises users to consider programming the “tachy therapy enabled/disabled” function to disabled prior to proceeding with the software upgrade. it is imperative to re-interrogate the device and program the “tachy therapy enabled/disabled” function to enabled after the upgrade has been successfully completed. as with any device evaluation and programming, ecg monitoring and availability of back up external defibrillation equipment is recommended during the entire software upgrade process.
according to the local supplier, the affected products were distributed in hong kong.
for details, please visit the following mhra website:
http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/
fieldsafetynotices/con261823
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 23 april 2013.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: st jude medical amplatzer atrial septal occluder
the united states food and drug administration (fda) has issued a medical device safety alert concerning amplatzer atrial septal occluder (aso), manufactured by st jude medical.
the fda is alerting health care providers and patients that in very rare instances, tissue surrounding the amplatzer aso can break down (erode) and result in life-threatening emergencies that require immediate surgery. according to published estimates, these events occur in approximately 1 to 3 of every 1,000 patients implanted with the amplatzer aso. as of 31 march 2013, there have been 234,103 amplatzer aso devices sold worldwide.
according to the fda, tissue erosion caused by the amplatzer aso is rare, but can be life-threatening. between 2002 and 2011, the fda received more than 100 reports of erosions associated with the st. jude amplatzer aso. during the same period, several medical journals contained articles reporting tissue erosion among patients implanted with this device.
the device rubbing against the wall of the heart can erode the tissue and create a hole. it can also lead to further scraping or erosion through tissue in the upper chambers (atria) of the heart, primarily in the top of the atria near the aorta. this scraping may also cause separate or simultaneous holes in the aortic root, potentially leading to blood building up in the sac surrounding the heart (cardiac tamponade). if too much blood builds up in this sac, the heart will not be able to work properly.
immediate open heart surgery may then be necessary to remove the device, close the holes or other defects caused by erosion, and close the original defect the device was meant to treat less invasively. tissue erosion can also cause fistulas - abnormal scar tissue that connects parts of the heart that were not previously connected. fistulas are not life-threatening, but do require surgery for treatment and could result in congestive heart failure.
the fda does not recommend device removal for patients who have the amplatzer aso unless physicians determine it is appropriate for their particular patient(s). the risks associated with device removal surgery may be equal to or greater than the risk of erosion. in addition, the fda is requiring st. jude to conduct a study of patients who have been recently implanted with the device so as to better understand how erosion impacts the performance of the amplatzer aso and assess potential risk factors related to the occurrence of erosion.
for details, please visit the following fda websites:
http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm371202.Htm
http://www.Fda.Gov/medicaldevices/safety/alertsandnotices/ucm371145.Htm
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 18 october 2013.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: st. jude medical implantable devices- fortify, fortify assura, quadra assura, quadra assura mp, unify, unify assura and unify quadra
medical device manufacturer, st jude medical, has issued a medical device safety alert concerning its implantable cardioverter defibrillators (icds) and cardiac resynchronization therapy defibrillators (crt-ds) manufactured before may 2015. the affected models are fortify, fortify assura, quadra assura, quadra assura mp, unify, unify assura and unify quadra.
according to the manufacturer, among 398,740 devices sold worldwide, 841 devices returned for analysis due to premature battery depletion have had evidence of lithium material in the form of “clusters” in the battery. forty-six exhibited visible clusters bridging the cathode and anode causing shorting. lithium cluster formation is a known phenomenon with this type of battery.
the manufacturer is contacting physicians to provide details regarding risk and patient management recommendations because premature battery depletion has been observed to occur within days. there have been two deaths that have been associated with the loss of defibrillation therapy as a result of premature battery depletion.
high voltage devices (icds and crt-ds) that utilize lithium-based battery chemistries are subject to lithium cluster formation during high voltage charging. depending on their location, lithium clusters may cause a short circuit that can lead to premature battery depletion. the manufacturer’s investigation indicates that if a short circuit occurs, battery depletion can occur in these devices within a day to a few weeks, which may result in the inability to deliver therapy.
premature battery depletion can be identified by physicians through home monitoring or in person visits showing elective replacement indicator (eri) or more advanced battery depletion. patients may become aware when their device reaches eri because they may feel a vibratory patient notifier alert. patients who cannot feel the vibratory alert may not know their device has reached eri. therefore, the manufacturer has provided recommendations below that include confirming patients can feel and recognize vibratory alerts and reaffirming the availability and usage of home monitoring to avoid or minimize time without device therapy for bradycardia and tachycardia events.
the manufacturer provided physicians with the following patient management recommendations:
do not implant unused affected devices.
conduct patient follow-up per standard practice.
prophylactic device replacement is not recommended because complications following replacement have been reported to occur at a greater rate than the rate of harm associated with premature battery depletion due to lithium cluster induced shorts.
in the event of an eri indicator in these devices, immediate device change is recommended. at this time there is no factor, method or test to identify devices with this form of premature battery depletion approaching eri or to accurately predict remaining battery life once eri appears.
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for further patient management recommendations and other necessary actions.
posted on 11 october 2016.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: st. jude medical ellipse vr/dr implantable cardioverter defibrillators
the australia therapeutic goods administration (tga) posted a medical device safety alert concerning ellipse vr/dr implantable cardioverter defibrillators (icds) manufactured by st. jude medical. the affected models are cd1277 (-36 and -36q), cd1377 (-36, -36q, -36c and -36qc), cd2277 (-36 and -36q) and cd2377 (-36, -36q, -36c and -36qc). icds with serial numbers beginning with “1” that are below 1132470, beginning with the number “7” that are below 7126267 and all serial numbers beginning with an “8” are affected.
the manufacturer has received complaints that extended charge time may present as a result of internal damage to the capacitors used in the high voltage charging circuitry of the subject devices. as designed, the device will deliver the available energy on the capacitors once the charge time limit of 32 seconds is reached, even if the energy is less than the programmed value.
this anomaly may occur during capacitor maintenance or charging for high voltage therapy, and may result in delayed delivery of high voltage therapy and/or delivery of part of a programmed high voltage therapy shock.
according to the manufacturer, there have been no reported cases of an ellipse device failing to deliver high voltage therapy to a patient when needed.
the manufacturer is providing appropriate patient management recommendations to surgeons for managing patients who are implanted with the affected devices.
furthermore, the manufacturer advises customers that the affected stock will be retrieved and replaced by new ellipse icds with the redesigned high voltage capacitor eliminating the source of capacitor damage at the front alignment hole.
for details, please refer to tga website:http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2014-rn-00905-1
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 20 august 2014.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: st. jude medical riata and riata st silicone endocardial leads
the united states food and drug administration (fda) has issued a press release and safety notices concerning riata and riata st silicone endocardial leads manufactured by st. jude medical inc. riata and riata st leads connect an implantable cardioverter defibrillator (icd) to the heart in order to monitor heart rhythms. icd can detect life threatening heart rhythms and deliver an electrical shock from the icd through the lead to the heart.
in december 2010, st. jude medical reported that the outer insulation material, silicone rubber, had been observed to be vulnerable to abrasion and might lead to premature insulation failure that could impact the lead's ability to function properly. lead insulation failure may cause the icd lead to malfunction. icd lead malfunction may cause abnormal sensing or pacing, or delivery of inappropriate or no shock therapy, which could result in serious adverse events, including death. st. jude had phased-out all models of riata and riata st silicone leads in december, 2010.
according to the fda, the increase in frequency of reported riata insulation failures began approximately four years after implantation. however, there is currently not enough information to determine how often and how soon the riata insulation fails and the risk factors of insulation failure or externalization of the electrical conductors. the fda issued a press release and safety notices to provide information and recommendations regarding safety concerns with the products.
recommendations for healthcare professionals:
the affected patients should be monitored closely and assessed for any electrical abnormalities.
physicians should image riata and riata st leads implanted in patients to assess for externalization or other visible insulation abnormalities, if it is not contraindicated.
physicians should consider remote monitoring for patients to better detect electrical abnormalities.
st. jude medical recommends reprogramming the device to increase the chance for detection of a lead abnormality. the patient alert and remote monitoring alerts should also be turned on.
the fda, st. jude medical and the heart rhythm society do not recommend routine removal of any leads due to the risks of explantation surgery. physicians should only consider replacing the lead if there is evidence of insulation failure in imaging and if there is abnormal electrical function.
recommendations for patients:
patients should contact their cardiac physician to determine if they have the affected leads.
patients are advised to discuss with the physicians to find out the best management plan they should adopt.
the fda is requiring st. jude medical to conduct three-year post-market surveillance studies to address concerns related to premature insulation failure and to address important questions related to follow-up of affected patients.
according to the local supplier, the affected models have been distributed in hong kong. for details, please refer to fda website:
http://www.Fda.Gov/medicaldevices/safety/alertsandnotices/
ucm314930.Htm
http://www.Fda.Gov/newsevents/newsroom/pressannouncements/
ucm315684.Htm
http://www.Fda.Gov/safety/medwatch/safetyinformation/
safetyalertsforhumanmedicalproducts/ucm315718.Htm
patients who have icd with riata and riata st leads, please contact their physician for necessary actions. for healthcare professionals, please contact your supplier for information.
posted on 17 august 2012.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Field safety notice: sd bioline hiv-1/2 v3.0
the world health organization (who) issued a field safety notice on 16 nov 2011 concerning sd bioline hiv-1/2 v3.0 manufactured by standard diagnostics, inc. according to the notice, some lots of the device showed unacceptably high rate (around 50%) of invalid test results.
subsequently, who issued an information update on 6 jan 2012 stating that the devices giving invalid test results show a substantial red background in the test window where results are read. this blurs the visibility of the test lines and therefore makes correct interpretation of the test result impossible. this means that no test result can be given, rendering the test invalid.
standard diagnostics has conducted a root cause analysis as recommended by the who and determined the problem was due to defective sample pad and non-standard shape of nozzle leading to excessive assay diluents migration which would blur the test window where results are read.
according to who, there is no evidence that would warrant the retesting of individuals for whom an unambiguous, valid positive or negative test result using this test, has been obtained. a positive hiv test result given to an individual should always be confirmed with a second and/or third test different from the initial screening test. persons whose test results were invalid (non-readable) would need to be retested as their serostatus remain undetermined.
who recommended that national authorities should discontinue use of all affected lots of the product and quarantining also the unaffected lots until further testing can determine their performance.
further, who also recommended any pending procurement of the product should be cancelled, and no new procurement initiated until further notice. who will re-inspect the manufacturing site and an information update will be issued afterwards.
according to the local supplier, affected lots have not been distributed in hong kong.
if you are in possession of the products, please contact your supplier for necessary actions.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert:standard diagnostics bioline hiv and malaria rapid test kits
the world health organization (who) has issued a notice of concern on the following products manufactured by standard diagnostics, inc.
sd bioline hiv ag/ab combo
sd biolime hiv-1/2 3.0
sd bioline malaria ag p.F/pan
sd bioline malaria ag p.F
an inspection of manufacturing of the above mentioned products was conducted by the who prequalification of diagnostics programme from 28 september to 1 october 2010 at the hagal-clong giheung-gu site of standard diagnostics. on the 3 november 2010, standard diagnostics received the who final inspection report for this first inspection that contained a significant number of nonconformities but did not include critical nonconformities.
a re-inspection of the hagal-dong giheung-gu site and an inspection of the newly acquired bora-dong giheung-gu site took place on 6-9 march 2012. the inspection team found that the manufacturer had not effectively implemented rectification of the requirements according to their action plan from the first inspection. the re-inspection revealed a significant number of major and critical nonconformities. there were 5 critical nonconformities detected:
lack of adequate document control.
misleading information presented to the who inspection team.
production processes were not sufficiently under control, not qa driven and not independent of production.
lack of precise identification and traceability throughout production processes.
lack of adequate quality control over in process and release of test kits.
according to who, the effectiveness of the quality management system at standard diagnostics, inc. had deteriorated since the first who inspection and requires considerable rectification before confidence in the quality of the products being produced by standard diagnostics, inc. is re-established.
who will withhold prequalification of all active applications for products manufactured at the above mentioned sites, and close any other applications received. this will remain in effect until these nonconformities have been satisfactorily addressed and who has verified and confirmed the acceptability of the corrective actions. for sd bioline hiv-1/2 3.0, it will not be eligible for procurement by who until further notice.
if you are in possession of the products, please contact your supplier for necessary actions.
posted on 10 july 2012.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Field safety notice: thoratec heartmate ii® left ventricular assist system.
medical device manufacturer, thoratec corporation, has issued a field safety notice on the use of thoratec heartmate ii® left ventricular assist system. the affected devices included all lot numbers of the heartmate ii® left ventricular assist system
sealed outflow graft short bend relief (catalog no. 104692) and thoratec heartmate ii sealed outflow graft (catalog no. 103393). all serial numbers of the thoratec heartmate ii implant kit with sealed grafts (catalog nos. 104911 and 104912).
the manufacturer is aware of a recent trend in reports of disconnection of the bend relief from the sealed outflow graft, a component of the heartmate ii lvas. the bend relief is a tube of eptfe surrounding the outflow graft proximal to the pump that is designed to prevent kinking of the outflow graft.
disconnection of bend relief from the sealed outflow graft may potentially lead to outflow graft kinking and/or graft abrasion. symptoms of outflow graft kinking included low pump flow, hemolysis, bleeding, and fluctuations in pump flow, speed and/or power, or worsening symptoms of heart failure. graft abrasion may lead to serious bleeding.
so far, the manufacturer has identified 29 reports of disconnected bend relief. five of the reports had symptoms of outflow graft kinking with one of them died of multi-organ failure. however, it is not clear as to what extent the disconnected outflow graft bend relief may have caused or contributed to this patient’s condition. besides, there were also three reports of serious bleeding that might be due to graft abrasion.
according to the local supplier, the affected device has been distributed in hong kong but there were no similar adverse events reported here. if you are in possession of the product, please contact your supplier for necessary actions.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: backup battery expiration for "pocket" system controller used with the heartmate ii left ventricular assist system
the united states food and drug administration (fda) has issued a medical device safety alert concerning backup battery expiration for "pocket" system controller used with heartmate ii left ventricular assist system (lvas), manufactured by thoratec corporation. the serial number on the system controller started with the letters "pc".
the manufacturer issued a voluntary urgent medical device correction letter to all hospitals which have patients supported with the heartmate ii lvas reminding them to monitor the expiration date of the backup battery contained within the heartmate ii "pocket" system controllers, as specified in the product instructions for use (ifu).
according to the manufacturer, this backup battery has a 36 month expiration date; an advisory alarm, indicated by a yellow wrench symbol, is triggered at 12:00 a.M. on the first day of the month in which the backup battery expires. it is important to note that exceeding the backup battery expiration and any associated advisory alarms do not affect normal heartmate ii lvas function.
while the ifu of heartmate ii lvas provides information on monitoring and changing the backup battery before it reaches the 36 month expiration date, the manufacturer has recently received reports from several hospitals about a number of patients who encountered an advisory alarm due to the expiration of their system controller backup batteries. some of these patients who received the advisory alarm attempted to switch from their primary to backup system controllers, and of those, three were unable to connect their pumps to their backup system controllers in a timely manner, resulting in two patient deaths and one serious injury.
the manufacturer is working with hospital staff to identify patients that may be close to reaching the 36-month expiration date of their system controller backup batteries in order to facilitate priority replacement and to ensure routine monitoring of backup battery lifetime during clinic visits, as specified in the product ifu. the manufacturer also advises the patients who received the affected products with certain serial number and experienced an advisory alarm should contact their doctors or hospitals for further instructions and do not attempt to replace the system controllers unless otherwise instructed.
for details, please refer to the fda website:http://www.Fda.Gov/safety/recalls/ucm462627.Htm
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 16 september 2015.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Press release
Cause
Safety information regarding st. jude medical implantable cardioverter defibrillators
10 october 2005
the department of health was notified today by the manufacturer of several older generation implantable cardioverter defibrillators that some of its products may be affected by cosmic rays and may not function properly.
according to st. jude medical (hong kong) ltd., the affected models are:
photon dr (model v-230hv) (certain serial numbers)
photon micro vr/dr (models v-194/v-232)
atlas vr/dr (models v-199/v-240)
no serious patient injury or death has been reported so far.
there are totally 34 patients implanted with the affected devices through the public hospitals in hong kong. the supplier has advised the hospital authority of this matter. all the affected patients will be informed by their doctors for follow up actions shortly.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Press release
Cause
Medical device alert for blood glucose meters the department of health (dh) was notified by the food and drug administration of the united states today (september 11) about a worldwide medical device alert on a type of blood glucose meters, the display screen of which may not work properly when dropped onto a hard surface.
a dh spokesman said the alert was initiated by the manufacturer, abbott diabetes care, involving blood glucose meters manufactured after january 2007.
the display screen of the affected meters, marked as "abbott optium xceed", may not work properly or may appear blank if dropped on a hard surface, thus making the users unable to view the blood glucose test results.
it was revealed that a total of 857 affected devices were sold in hong kong but none of them were released to hospitals.
as a precautionary measure, users should not use the blood glucose monitor if the display shows missing or blank section. they should contact the local agent or supplier for replacement.
"users should ensure a full display show each time the blood glucose monitor is turned on, especially before using the monitor to check the blood glucose level," the spokesman said.
the spokesman said dh had alerted the hospital authority, private hospitals, nursing homes and medical professional associations to this medical device correction.
dh has not received any report of adverse events arising from this issue.
the spokesman said members of the public using the meters concerned should contact the local agent by calling its hotline 2806 4488 during office hours for advice.
relevant information is available at the manufacturer's website.
ends/tuesday, september 11, 2007
nnnn.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Press release
Cause
Software defect causes malfunction in implantable cardioverter-defibrillator the department of health (dh) today (may 6) received notification from st. jude medical (hong kong) ltd., a local branch of a multi-national company, about a software problem in its convert+ model v-195 implantable cardioverter-defibrillator (icd).
the model, if programmed by a merlin pcs programmer running version 7.2.1, version 8.2.1 or version 10.2.0 software, may not deliver therapy under certain circumstances. the defect can be corrected. st jude medical recommends doctors who have programmed a patient's device with any of the affected software versions should schedule a follow-up visit to perform the correction recommended by it.
according to st. jude medical (hong kong) ltd., one patient has been implanted with this model of icd in hong kong. however, the implanted device has not been programmed with the affected software version. this model of icd ceased to be sold by the company in hong kong since mid-2007.
no patient injury or death has been reported worldwide.
patients may call st. jude medical (hong kong) ltd. at 9682 0488 for further details.
a dh spokesman reminded patients with implanted icds that they should seek medical attention immediately if they felt unwell.
meanwhile, the dh has informed both public and private hospitals, and relevant medical associations of the issue, and will also follow up with st. jude medical (hong kong) ltd. on further development, if any.
end/thursday, may 6, 2010.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Press release
Cause
Blanket recall of abbott glucose test strips the department of health (dh) has today (december 29) requested a local medical device supplier, abbott laboratories limited, to recall all its glucose test strips from consumers as a further precautionary measure to safeguard public health.
a spokesman explained that further to the recall of 359 lots of abbott's glucose test strips under six brand names announced on december 23, dh noted that the recall list of abbott glucose test strips in the us has been expanding over the holiday to some 10 brands, involving over 380 lots.
meanwhile, singapore's health sciences authority issued another recall list of 43 lots under the brand name of "abbott medisense optium blood glucose test strips", some lots of which are also on the us' latest list above.
"in view of uncertainties at this stage over the exact number of brands and lots affected, dh requested abbott to recall all their test strips from the hong kong market in order to be vigilant. consumers are advised to stop using any abbott glucose test strip they have in hand immediately as the strips may show lower than actual readings. high blood sugar poses health risks and can be life threatening", the spokesman said.
"consumers can contact the company's 24-hour hotline at 8302 0507 on recall arrangements. whenever in doubt, they may also consult their healthcare workers for individual advice."
29 dec 2010.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Press release
Cause
Resumption of sale of abbott's optium omega glucose test stripsthe department of health (dh) has today (january 11) agreed to allow one brand of abbott's glucose test strips, optium omega, to re-enter the market.
a spokesman for dh said that the decision was based on consideration of information in hand, especially the differences in design and manufacturing of optium omega and the supply of alternatives on the market.
dh, through its routine surveillance system, captured a us food and drug administration (fda) alert about the recall of over 380 lots, involving some 10 brands, of glucose test strips marketed by abbott diabetes care in the us late last december.? this is due to ineffectiveness of the strips - there are possibilities of obtaining falsely low blood glucose readings instead.?
to allow time for proper investigation and as a precautionary measure to safeguard hong kong's public health, dh requested the local medical device supplier, abbott laboratories limited, to recall all its glucose test strips from consumers on december 29 last year.
"as optium omega's unique design and manufacturing could ensure its exemption from ineffectiveness, dh thinks it reasonable to allow its re-entry into the local market, especially alternatives are not in abundance here in hong kong," a dh spokesman explained.
"however, any time users are in doubt of the accuracies, they should stop using the strips and consult their healthcare providers," he further remarked.
dh would continue to follow-up with the investigation and also closely monitor the recall of other brands of abbott’s glucose test strips.
ends/tuesday, january 11, 2010.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Product recall: abbott diagnostics clinical chemistry alkaline phosphatase reagent
abbott diagnostics (abbott) has issued an urgent product recall on clinical chemistry alkaline phosphatase reagent lots 71628un10, 62474un10, and 08145un11, due to particulate matter in some reagent cartridges, which has been identified as a cladosporium fungal species. according to abbott, the fungus does not represent a hazard, but appears to generate visible clumps within the reagent cartridge, and may cause discoloration over time.
abbott supplemented that they have not received reports of inaccurate alkaline phosphatase results due to this issue, nor has internal testing demonstrated any impact to results; however, having confirmed the error codes on calibration and sample runs, internal data suggests a rare (0.00636%) potential for inaccurate results to exist.
the supplier suggests that, if you are using or have inventory of clinical chemistry alkaline phosphatase (ln 7d55-21 lot 71628un10, or ln 7d55-31 lot 62474un10 and/or lot 08145un11), you should discontinue use and destroy any remaining inventory of those lots in accordance with your institution’s policies and procedures.
according to the local supplier, the affected products have been distributed in laboratories in hong kong.
if you are in possession of the affected product, please contact your supplier for necessary actions.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Press release
Cause
Safety alert over abbott's freestyle insulinx blood glucose monitoring system today (november 2), the department of health (dh) draws public's attention to abbott diabetes care 's recall of its freestyle insulinx blood glucose monitoring system (the system) in the united kingdom, as software error in certain lots may lead to resetting of the system, including recommending the use of "0" unit of insulin even if the blood glucose readings are high, thereby having the potential of causing users to mismanage their diabetes mellitus.
a dh spokesman reveals the department comes to know of the incident through its routine surveillance scheme on medical device. the system is meant to be used by diabetic patients for self-monitoring of their blood glucose status and is a device which can also offer suggestions on insulin doses required.
according to the report filed by abbott to the uk authority, the defect is detected by its ongoing internal quality process. when the "backup" and "restore" functions of the freestyle auto-assist software inside the system are used for the first time, certain settings in the system may be reset.
"besides the insulin calculator values, affected ones can include sound preferences, notes, reminders and weekly messages. neither is the blood glucose reading displayed nor the data stored involved," the spokesman quotes.
abbott's investigation points that the defect is limited to certain lots and serial number of systems of a specific part number, with details as follows -
part number
lot number
description
potentially affected meter serial number range
71148 - 70
01r139f
01r146f
02r145f
02r153f
03r153f
freestyle insulinx blood glucose
monitoring
system
all serial numbers where the beginning seven(7) characters fall within the range:
jamr128 – jamr252
preliminary enquiry with the local supplier, abbott laboratories limited, reveals that the concerned freestyle insulinx system is mainly distributed in europe and has not been launched in hong kong.
"although the system is not marketed in hong kong and we have no record of related adverse event here or overseas, the fact that there may be occasional patients in the territory who have somehow obtained the devices from abroad and the dreaded consequences together justify a public alert, in our opinion," the spokesman remarks.
“people who have devices belonging to the failed lots should contact abbott laboratories limited for advice and follow-up,” the spokesman urges. the company has set up a hotline at phone 2806 4488 to answer related enquiries.
meanwhile, dh has informed all public and private hospitals, related medical associations and healthcare professionals about the matter and also advised them to stay vigilant.
the spokesman further reminds that for those customers who have used the said product and are either feeling unwell or in doubt, they should consult their healthcare professionals for advice as soon as possible.
ends/wednesday, november 2, 2011.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Field safety notice: st. jude medical quicksite® and quickflex® left ventricular crt leads [models 1056t, 1058t, 1156t and 1158t]
medical device manufacturer, st. jude medical, initiated a field safety corrective action concerning the quicksite® and quickflex® left ventricular crt leads [models 1056t, 1058t, 1156t and 1158t].
according to the manufacturer, the affected devices are designed for use in combination with a compatible pulse generator to provide long-term stimulation and sensing of the left ventricle via the great cardiac vein or one of its tributaries.
the manufacturer had found 39 confirmed cases of externalized conductor. it was estimated that 3-4% of quicksite® and quickflex® leads may exhibit the anomaly. there were no reports of death or serious injury associated with externalized conductor.
according to the manufacturer, if externalization of the cable conductor were to occur, the etfe coating on the cables is designed to provide adequate dielectric strength for the lead to continue to function normally without the silicone covering. the system also provides for multiple alternative pacing configurations that can be programmed, if needed. although no electrical dysfunction attributable to these external conductors has been observed to date, in the case that all of these redundancies were to fail, the inability of the lv crt lead to pace could affect biventricular pacing and result in exacerbation of heart failure.
the manufacturer recommended physicians to continue to monitor their patient’s implanted system at regularly scheduled intervals with attention paid to diagnostic information related to lv pacing performance, in particular lv lead impedance and capture thresholds. in addition, programming of alerts that monitor lead impedance changes outside of the nominal range and enabling the patient notifier should be considered.
according to the local supplier, the affected products were distributed in hong kong.
if you are in possession of the products, please contact your supplier for necessary actions.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: abbott architect ca 19-9xr
medical device manufacturer, abbott laboratories issued a safety alert concerning certain lots of architect ca 19-9xr reagent.
abbott has confirmed that these six architect ca 19-9xr reagent lots are demonstrating a shift up in patient results. an internal investigation is in process. initial indications suggest that the issue is caused by the conjugate component as all lots identified above share the same conjugate component.
this issue may impact patient management when affected lots are used in monitoring of patients. therefore, abbott advised users to stop using the affected units and destroy any remaining inventory of the lots listed above.
according to the local supplier, the affected products have been distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted 4 june 2012.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: st.Jude medical merlin@home transmitter
the health canada posted a medical device recall notice concerning merlin@home transmitter, manufactured by st. jude medical, cardiac rhythm management system. the affected model number is ex1150.
according to the manufacturer, there is potential for intermittent communication difficulties with these merlin@home transmitters due to an anomaly with a microcontroller chip in the transmitter. if the anomaly occurs, the patient's merlin@home transmitter will not be able to send data to the merlin.Net database. however, implanted device function is not affected.
for details, please refer to health canada website
http://www.Hc-sc.Gc.Ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_apr-june_2012-eng.Php
if you are in possession of the product, please contact your supplier for necessary actions.
posted on 27 jun 2012.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: abbott ht connect peripheral guide wires
medical device manufacturer, abbott laboratories limited has issued a medical device safety alert concerning ht connect peripheral guide wires. part numbers from 1012587 to 1012595 are affected.
the above affected products are now being recalled due to a small number of devices exhibiting partial delamination of the ptfe coating. to date, the frequency of worldwide reported incidents of delamination of the coating is 0.08%.
while abbott has received no reports on long term or irreversible patient effects, potential risks associated with this problem include embolism, thrombus and occlusion in the peripheral vessels.
abbott has stopped distributing the affected products while evaluating appropriate corrective and preventive actions. the manufacturer will replace the returned unused units with similar products, pending availability.
according to the local supplier, the affected products were distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 25 november 2013.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Press release
Cause
Recall of certain lots of freestyle and freestyle lite blood glucose test strips
the department of health (dh) today (november 25) drew public attention to abbott diabetes care's recall of certain lots of its two brands of blood glucose test strips, namely freestyle and freestyle lite, due to the potential for giving erroneously low blood glucose results when using in conjunction with certain brands of blood glucose meters also manufactured by the company.
the dh, through its routine surveillance on medical devices, noticed a recall notice issued by the therapeutic goods administration (tga) of australia involving two lots of freestyle lite blood glucose test strips (lot number: 1366540 and 1366621).
according to tga, the two affected lots have the potential to give readings that are incorrectly low when used in conjunction with freestyle papillon mini blood glucose meters.
when conducting follow-up to tga's alert, dh noticed that abbott diabetes care in the us has posted a recall notice on its company website, announcing that certain lots of freestyle and freestyle lite blood glucose test strips (lot numbers: 1281732, 1283345, 1283603, 1285007, 1350414, 1363015, 1363109, 1363321, 1365056, 1365920, 1365921, 1365934, 1366006, 1366111, 1366337, 1366347, 1366515, 1367917, 1373262 and 1374907) may also produce falsely low blood glucose results when they are used with freestyle blood glucose meters, freestyle flash blood glucose meters and the freestyle blood glucose meter built into the omnipod system.
a spokesman for the dh explained that falsely low blood glucose readings may mislead a diabetic patient into inappropriate management of his or her condition, resulting in hyperglycemia.
"although preliminary enquiry with the local supplier, abbott laboratories limited, reveals no evidence of the affected products having been distributed in hong kong, a public alert is justified as there may be patients in the territory who have obtained the devices or test strips from abroad or from internet purchase," the spokesman remarked.
"dh will continue to follow up with the supplier to further verify whether other brands and lots are affected and their distribution," the spokesman said.
so far, the dh has not received any local report of adverse events arising from use of the affected products.
people who have the test strips belonging to the affected lots and are using the specific brands of glucose meters concerned should contact abbott laboratories limited for advice and follow-up," the spokesman urged.
the company has set up a customer service hotline 5808 4196 to answer related enquiries.
ends.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Press release
Cause
Further recall of selected lots of freestyle lite blood glucose test strips
the department of health (dh) today (november 26) drew public attention to abbott diabetes care's further recall of other selected lots of its freestyle lite blood glucose test strips due to the potential for giving erroneously low blood glucose results when used in conjunction with certain brands of blood glucose meters also manufactured by the company.
further to the press release issued by the dh yesterday (november 25) on the recall of certain lots of freestyle and freestyle lite blood glucose test strips by abbott diabetes care, the department, through its routine surveillance on medical devices, noticed abbott diabetes care's recall notice posted by the united kingdom's medicines and healthcare products regulatory agency involving three other lots of freestyle lite blood glucose test strips (lot numbers: 1284962, 1366626 and 1372611).
according to the notice, the three affected lots may produce erroneously low blood glucose results and out of range control solution results when used in conjunction with freestyle blood glucose meters, freestyle mini blood glucose meters, freestyle navigator and the freestyle meter built into the omnipodsystem.
a spokesman for the dh explained that falsely low blood glucose readings may mislead a diabetic patient into inappropriate management of his or her condition, resulting in hyperglycaemia.
"preliminary enquiries with the local supplier, abbott laboratories limited, revealed no evidence of the affected products having been distributed in hong kong. the dh will continue to monitor the situation," the spokesman said.
so far, the dh has not received any local reports of adverse events arising from use of the affected products.
people who have the test strips belonging to the affected lots and are using the specific brands of glucose meters concerned should contact abbott laboratories limited for advice and follow-up," the spokesman stressed.
the company has set up a customer service hotline, 5808 4196, to answer related enquiries.
ends.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Press release
Cause
Further recall of freestyle and freestyle lite blood glucose test strips
the department of health (dh) today (november 28) drew public attention to abbott diabetes care's further recall of other lots of its freestyle and freestyle lite blood glucose test strips due to the potential for giving erroneously low blood glucose results.
further to the press releases issued by the dh on november 25 and 26 on the recall of certain lots of freestyle and freestyle lite blood glucose test strips by abbott diabetes care, the local supplier abbott laboratories limited informed the dh that 18 other lots of freesytle and freestyle lite blood glucose test strips have to be recalled (lot numbers: 1280623, 1281310, 1281424, 1282651, 1284924, 1355751, 1358061, 1359207, 1365062, 1366208, 1366620, 1369334, 1372550, 1372652, 1373413, 1376121, 1376216 and 1376259). the full list of affected lots is in the appendix.
although these affected strips may give rise to erroneous results when used with certain brands and models of glucose meters, the dh advised the public to stop using the affected test strips, irrespective of the brand or model of the glucose meters they are using, as a precautionary measure and to avoid causing confusion.
a spokesman for the dh explained that falsely low blood glucose readings may mislead a diabetic patient into inappropriate management of his or her condition, resulting in hyperglycemia.
"enquiries with the local supplier, abbott laboratories limited, revealed no evidence of the affected test strips having been distributed in hong kong," the spokesman said.
so far, the dh has not received any local reports of adverse events arising from use of the affected products.
"people who have test strips belonging to the affected lots listed in the appendix should contact abbott laboratories limited for advice and follow-up," the spokesman stressed.
the company has set up a customer service hotline, 5808 4196, to answer related enquiries.
ends.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Press release
Cause
Recall of certain brands of abbott diabetes care blood glucose monitoring systems
the department of health (dh) today (february 28) drew public attention to the recall by abbott diabetes care of certain brands of its blood glucose monitoring systems which may produce inaccurate glucose results.
the dh received the above safety alert from the local supplier, abbott laboratories limited. the manufacturer, abbott diabetes care, has identified through internal testing and investigation that certain brands of their blood glucose monitoring systems, namely freestyle, freestyle flash, freestyle papillon, freestyle mini, freestyle papillon mini, optium mini blood glucose meters, freestyle navigator continuous glucose monitoring system and freestyle blood glucose meter built into the omnipod insulin management system, have the potential to produce erroneously low blood glucose results when used in conjunction with any freestyle test strip.
a spokesman for the dh explained that falsely low blood glucose readings may mislead a diabetic patient into inappropriate management of his or her condition, resulting in hyperglycemia.
so far, the dh has not received any local report of adverse events arising from use of the affected products.
people who are using the specific brands of glucose meters concerned should contact abbott laboratories limited for advice and follow-up," the spokesman added.
the company has set up a customer service hotline 5808 4196 to answer related enquiries.
ends/friday, february 28, 2014.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: abbott vascular nc trek rx coronary dilatation catheter, nc traveler rx coronary dilatation catheter, and nc tenku rx ptca balloon catheter
william cook europe has issued a medical device safety alert concerning its zenith alpha thoracic endovascular graft (zta-). [catalog numbers: zta-d-28-160, zta-d-28-229, zta-d-30-160, zta-d-30-229, zta-d-32-160, zta-d-32-229, zta-d-34-142, zta-d-34-190, zta-d-36-142, zta-d-36-190, zta-d-38-147, zta-d-38-197, zta-d-40-147, zta-d-40-197, zta-d-42-152, zta-d-42-204, zta-d-44-157, zta-d-44-211, zta-d-46-157, zta-d-46-211, zta-de-18-104, zta-de-18-148, zta-de-20-104, zta-de-20-148, zta-de-22-104, zta-de-22-148, zta-de-24-104, zta-de-24-148, zta-de-26-104, zta-de-26-148, zta-de-28-108, zta-de-28-154, zta-de-30-108, zta-de-30-154, zta-de-32-108, zta-de-32-154, zta-de-34-112, zta-de-34-160, zta-de-36-112, zta-de-36-160, zta-de-38-141, zta-de-38-91, zta-de-40,-141 zta-de-40-91, zta-de-42-146, zta-de-42-94, zta-de-44-151, zta-de-44-97, zta-de-46-151]
the safety communication is to call the attention to several aspects of the new version of the instructions for use (ifu) for the zenith alpha thoracic endovascular graft. the updates are of key importance when using the device to treat blunt thoracic aortic injury (btai), which is covered under the newly approved indication for isolated lesions of the descending thoracic aorta.
the clinical trial patients with thrombus tended to have smaller graft diameters and greater oversizing on average than the patients without thrombus. similar trends were observed among the commercial reports as well, with those patients also tending to have a small aortic arch radius of curvature. additionally, while approximately 50% of the clinical trial patients had an aortic diameter that tapered from large proximally to small distally (by at least 10%), a tapered graft was not consistently used (20% received a tapered graft).
according to the manufacturer, the field safety notice is for information purposes. no devices need to be returned, and patients already treated for btai should be followed in accordance with the current ifu, since follow-up has not been amended.
according to the local supplier, the affected products are distributed in hong kong
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 22 march 2017.