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: boston scientific advanix biliary stent with naviflex rx delivery system
medical device manufacturer, boston scientific corporation issued a medical device safety alert concerning advanix biliary stent with naviflex rx delivery system (catalogue number: 3427, 3421, lot number: 15294885, 15335278 and 15416240).
boston scientific discovered a limited number of units were shipped from the china distribution centre without the appropriate chinese local label. these units are expected to have no clinical significance and no probability of injury. no relevant complaints have been reported to the manufacturer.
according to the local supplier, the affected products were not distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 24 may 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: boston scientific 13f/15f navigator hd ureteral access sheath set
medical device manufacturer, boston scientific corporation has issued a medical device safety alert concerning certain lots of 13f/15f navigator hd ureteral access sheath set with catalogue numbers 250-227, 250-228 and 250-229.
boston scientific has received reports from the field where the tip of the dilator has separated from the body of the dilator. to date, boston scientific has received 5 related complaints.
boston scientific expects the most common adverse health consequence of this problem would be a secondary intervention to remove the tip of the dilator.
according to the local supplier, the affected products were not distributed to hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 7 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
Medical Device Safety Alert
Cause
Medical device safety alert: boston scientific runway guide catheter
medical device manufacturer, boston scientific corporation, has issued a medical device safety alert concerning runway guide catheter with catalogue no.: 38969-664
and lot no.: 2013040058. the expiry date of the affected product is april 2016.
the manufacturer is initiating a product recall as the sterile pouch of the affected devices may not be completely sealed and sterility may be compromised. to date, the manufacturer has received one complaint for this issue.
the most common adverse health consequence expected from an unsealed pouch is a transient bacteremia, which may require antibiotic therapy.
according to the local supplier, the affected lot was not distributed to hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 07 march 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: boston scientific profile™ single-use pediatric snare
medical device manufacturer, boston scientific ltd, has issued an urgent field safety notice concerning the limited number of batches of the profile™ single-use pediatric snare.
the manufacturer has become aware through customer complaints that it may be difficult to fully extend the snare loop from the catheter. as a result, a minor delay to the procedure may occur. according to the manufacturer, no injury is reasonably expected to occur as a result of this issue.
according to the local supplier, the affected batches were not distributed in hong kong. for details, please refer to the attached field safety notice. if you are in possession of the product, please contact your supplier for necessary actions.
posted on 21 may 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: sybronendo buchanan medium pluggers
medical device manufacturer, sybron dental specialties, inc., has issued a field safety notice concerning the recall of certain lots of buchanan medium pluggers.
the manufacturer found that some lots of buchanan pluggers labeled as medium were assembled with fine medium tips instead of the correct medium tips. according to the manufacturer, the product will be able to reach appropriate proximity to the apex and therefore function as expected. there are no safety or efficacy issues associated with this assembly error.
sybron dental specialties reported that there are no hong kong consignees being affected by this recall.
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
Corrective action of guidant implantable cardiac pacemakers
19 july 2005
the department of health has been notified by the guidant corporation of an “urgent medical device safety information and corrective action” concerning some of their implanted cardiac pacemakers.
the pacemakers in question may experience premature battery depletion without warning, inappropriate pacing and early display of replacement indicators.
the affected pacemakers are pulsar max, pulsar, discovery, meridian , pulsar max ii, discovery ii, virtus plus ii, intelis ii and contak tr pacemakers manufactured between 25 november, 1997 and 26 october, 2000.
if these devices exhibit the above failure mode, patients may notice prolonged rapid heart beating and develop dizziness. in serious circumstances, though uncommon, they may develop heart failure symptoms such as shortness of breath and loss of consciousness.
the manufacturer has sent letters to doctors with patients implanted with the pacemakers to alert them of the incident, and advise replacement of the pacemakers where necessary.
affected patients are urged to contact their doctors for advice.
guidant hong kong limited has set up two hot lines 2593 2210 and 6292 2308 for public enquiry during office hours.
the department of health has alerted the hospital authority, private hospitals and medical associations of the corrective action undertaken by guidant on some of their cardiac pacemakers.
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
Voluntary recall of implantable cardiac defibrillators by guidant corporationjune 18, 2005
the department of health today (june 18) noted a worldwide recall of certain implantable cardiac defibrillators issued by the guidant corporation today. the affected devices are –
ventak prizm 2 dr (model 1861) icds manufactured on or before april 16, 2002
contak renewal (model h135) and contak renewal 2 (model h155) crt-ds manufactured on or before august 26, 2004
ventak prizm avt, vitality avt, renewal 3 avt and renewal 4 avt icds (all series numbers)
individual patients implanted with affected devices should contact their attending doctors and keep regular appointment. in case they feel an electrical shock, or hear an audible “beeping” from the device, they should immediately contact their doctor or go to the nearest hospital emergency department.
the department of health has informed public and private hospitals, medical professional associations and relevant patients’ groups about this recall action today.
guidant corporation has posted information for physicians on its web site at www.Guidant.Com.
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 guidant insignia and nexus implantable cardiac pacemakers
september 23, 2005
the department of health has been notified by the guidant corporation
of an "important medical device safety information and corrective
action" concerning their insignia and nexus implantable cardiac
pacemakers.
the concerned pacemakers may not function properly without warning
and can result in serious health complications, such as syncope
which required emergency hospitalization. there have been no reported
deaths associated with the malfunction of the affected pacemakers.
the manufacturer has advised doctors in hospital authority and
private hospitals of this important safety information. there are
115 patients implanted with the affected devices in hong kong and
they will be informed by their doctors for follow up actions in
a few days' time.
the department of health has alerted the hospital authority, private
hospitals and medical associations of this safety information.
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
Voluntary recall of heartbeat regulating products
27 june 2006 (tuesday)
the department of health (dh) received notification from a medical device manufacturing company about a voluntary recall of a number of devices used for regulating heartbeats, including cardiac pacemakers, cardiac resynchronization therapy pacemakers (crt-ps), and cardioverter defibrillators (icds).
the notification from guidant hong kong limited involved the following products -
insignia pacemakers,
nexus pacemakers,
contak renewal tr crt-ps,
contak renewal tr 2 crt-ps,
ventak prizm 2, icds,
vitality icds, and
vitality 2 icds.
it was found that five devices did not function as a result of failure of the capacitor leading to intermittent or permanent loss of output or premature battery depletion. to date, about 49 800 devices have been distributed and approximately 27 200 devices have been implanted worldwide.
there have been two overseas reports of pacemaker patients experiencing syncope. there have been no other reported serious incidents locally, no reports of adverse incidents have been received by dh.
according to guidant hong kong limited, i n hong kong , 32 devices have been implanted in hospitals under hospital authority (ha) and private hospitals. guidant has contacted ha and related doctors to advise them to follow up patients in their clinics as soon as possible.
individual patients implanted with affected devices should contact their attending doctors immediately if they have symptoms. patients may call guidant hong kong limited's hotline at 2593 2206 for enquiry.
the dh has informed public and private hospitals, and medical professional associations about this recall action and advise them to take necessary follow up actions. dh welcomes the timely actions taken by guidant as a responsible manufacturer to issue this recall.
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
Advisory notice on use of heartbeat regulating products the department of health (dh) received notification from a medical device manufacturing company about possible battery life-related problem of certain devices used for regulating heartbeats, including implantable cardiac defibrillators (icds) and cardiac resynchronization therapy defibrillators (crt-ds).
the notification from boston scientific hong kong limited involved the following products –
a subset of contak renewal 3 & 4 families of crt-ds and
a subset of the vitality and vitality 2 families of icds.
it was found that the problem is due to a low-voltage capacitor which may be subject to degradation, causing accelerated depletion of the batteries in the affected products.
so far 19 of approximately 73,000 devices overseas have been confirmed to have accelerated battery depletion. according to the company, there have not been any reported deaths or serious injuries resulting from the problem, both overseas and locally.
according to the boston scientific hong kong limited, in hong kong , 15 devices have been implanted in hospitals under hospital authority (ha) and three in private hospitals. boston scientific has contacted ha and related doctors to advise them to follow up with patients in their clinics as soon as possible.
individual patients implanted with affected devices should contact their attending doctors immediately if they have symptoms. patients may call boston scientific hong kong limited's hotline at 2960 7128 or visit boston scientific's website at http://www.Guidant.Com/ppr/advis/2007_04_05.Shtml for further details about the notification.
the dh has informed public and private hospitals, and medical professional associations about this notification and advised them to take necessary follow up actions.
ends
friday, april 13, 2007.
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: boston scientific promus elementtm everolimus-eluting coronary stent system
boston scientific has issued a product recall regarding three units of promus elementtm everolimus-eluting coronary stent system. according to the local supplier, hong kong is not affected.
the three units were shipped from the australia distribution center between may 30, 2011 and may 31, 2011 without the appropriate australia directions for use (dfu) inserted.
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
Medical Device Safety Alert
Cause
Field safety notice: boston scientific resolution® ii clip
boston scientific has issued a field safety notice to customers of resolutionr ii clip. according to the local supplier, hong kong is not affected.
the manufacturer states that following clip deployment, the alignment of the clip and delivery system does not allow for the withdrawal of the delivery system away from the clip. this has resulted in tissue trauma, increased bleeding and the clip being pulled off tissue as the delivery system is withdrawn.
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
Medical Device Safety Alert
Cause
Field safety notice: boston scientific katzen™ infusion wire
boston scientific has issued an urgent product recall of one lot/batch of katzen™ infusion wires (material no. (upn). m001461930; catalogue no. 46-193; lot/batch no. 14270326; expiry date march 2014) because the label on the carton and the inner pouch indicates an incorrect device length.
according to the manufacturer, no injuries are expected to occur as a result of this mislabeling. if physician could not reach the target anatomic location because the device was shorter than expected, a minimal delay in the procedure would occur. boston scientific suggests immediately ceasing further distribution or using of any remaining products affected by this recall. recalled products will be replaced.
according to the local supplier, hong kong is not affected.
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
Medical Device Safety Alert
Cause
Medical device recall: boston scientific expect™ endoscopic ultrasound aspiration needle
boston scientific issued an urgent product recall of one batch of incorrect labelled expecttm endoscopic ultrasound aspiration needle (product description; eus fna single pack 25ga; material/upn/catalog number m00550020; batch no.13615651c1; expiry date 30 june 2014). the pouch label upn number and device handle correctly indicate that it was a 25 ga device, while the graphics on the carton label indicated it was a 22 ga device.
according to the manufacturer, no injuries are reasonably expected to occur as a result of this mislabeling issue. boston scientific suggests that users should immediately discontinue use of the product and return to boston scientific.
according to the local supplier, hong kong is not affected by this recall.
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
Medical Device Safety Alert
Cause
Fda class i recall: boston scientific innova™ self-expanding stent system
fda has issued a class i recall on the boston scientific innova™ self-expanding stent system. a total of 72 products are affected and the manufacturer, boston scientific corporation, is conducting a recall of these products.
the innova™ self-expanding stent system is indicated for the treatment of peripheral vascular lesions. the manufacturer has received 6 complaints involving no deployment or partial deployment of the innova stents. potential health hazard events resulting from this type of failure include increased procedure time, vessel wall injury, and emergency surgery to remove the partially deployed stent. this recall does not affect stents that have already been implanted, as the issue occurs during delivery of the stent.
according to the local supplier, the affected products are not distributed in hong kong.
for details, please refer to the fda link: http://www.Fda.Gov/safety/recalls/enforcementreports/ucm270461.Htm
if you are in possession of the affected 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
Field safety notice: boston scientific twistertm rotatable polyp retrieval device
medical device supplier, boston scientific corporation, issued an urgent customer notification concerning twistertm rotatable polyp retrieval device. below is the list of affected products. all of them are expired on 30 november 2013.
product description
lot/batch number
twister polyp retrieval – 13mm (box 5)
h10081204, h10081206
twister polyp retrieval – 13mm (box 10)
h10081215, h10091601, h10091602
twister polyp retrieval – 32mm (box 1)
h10081255, h10081256
there is a labeling issue for twistertm rotatable polyp retrieval device that the inner pouch listed an incorrect upn number and basket size. however the outer box upn and basket size is correct for the device.
according to the local supplier, hk is not affected. if you are in possession of the affected 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
Field safety notice: boston scientific icd teligen, model nos.: f102, f103, f110, f111 and crt-d cognis, model nos.: p107 and p108
it comes to our attention that the state institute for drug control, czech republic received information from boston scientific that the below implantable cardioverter-defibrillator (icd) and defibrillator for cardiac resynchronization therapy (crt-d) were stolen from the service car of clinical engineer on march 01, 2012 in the territory of the czech republic.
trade name
model no.
material no.
serial no.
expiration date
icd teligen_he vr df1
f102
60f102-814
113139
4.8.2012
icd teligen_he vr df1
f102
60f102-814
114621
9.12.2012
icd teligen_he vr df4
f103
60f103-805
116879
16.12.2012
icd teligen_he dr df1
f110
60f110-814
117249
10.8.2012
icd teligen_he dr df4
f111
60f111-805
104766
6.7.2012
icd teligen_he dr df4
f111
60f111-805
104769
6.7.2012
crt-d cognis_he df1/is1
p107
60p107-814
113354
14.5.2012
crt-d cognis_he df1/is1
p107
60p107-814
115530
29.7.2012
crt-d cognis_he df4
p108
60p108-805
107564
4.10.2012
crt-d cognis_he df4
p108
60p108-805
107572
4.10.2012
crt-d cognis_he df4
p108
60p108-805
107921
10.11.2012
if you are in possession of the affected product, please contact boston scientific 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: boston scientific z°flex-270 steerable sheath
medical device manufacturer, boston scientific has issued a field safety corrective action regarding the recall of z°flex-270 steerable sheath (catalogue number 7050). all zo flex-270 steerable sheaths are affected by this recall.
according to the manufacturer, the investigation of four complaints revealed that the internal ptfe liner was damaged during use which may post a potential embolic risk to the patients. no adverse events or patient injuries have been reported to date.
according to the local supplier, the affected products were not distributed in hong kong.
the manufacturer advised all users to immediately discontinue the use of the affected products.
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 10 september 2012.
Czech data is current through July 2018. All of the data comes from the Czech Public Registry of Medical Devices, 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 the Czech Republic.