Events

Rappel de Device Recall Medtronic DLP, DLP Single Stage Venous Cannula w/Right Angle Metal Tip.

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Medtronic Inc. Cardiac Rhythm Disease Management.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    60720
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0807-2012
  • Date de mise en oeuvre de l'événement
    2011-12-14
  • Date de publication de l'événement
    2012-01-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-05-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106299
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
  • Cause
    Instructions for use for the dlp single stage venous cannulae are in the process of being updated. the current precaution statement referencing ventricular assist procedures will be identified as a contraindication in the updated instructions for use. do not use this product for extended terms such as ventricular assist procedures. medtronic has received two reports of patient deaths due to p.
  • Action
    Medtronic sent an "URGENT MEDICAL DEVICE INFORMATION" letter dated December 2011 to all affected customers. The letter identifies the product, problem, and the action to be taken by the customers. Contract Medtronic CardioVascular LifeLine Technical Support at 1-877-526-7890 for questions related to this issue.

Device

Device Recall Medtronic DLP, DLP Single Stage Venous Cannula w/Right Angle Metal Tip.
  • Modèle / numéro de série
    Model # / Lot #      69431 67312 67314 67316 2009010377 2008110555 2008101197 200808C074 2009010733 2008110584 2008101198 2008110082 2009011144 2008110593 2008101199 2008110085 2009030545 2008110627 200810C087 2008110088 200903C053 2008110628 2008110326 2008110227 2009050720 2008110769 2008111018 2008110238 2009051020 2008110932 2008111019 2008110456 2009060260 2008111015 200811C088 2008110457 2009060955 2008111016 2008120221 2008110471 2009070017 2008111017 2008120393 2008111020 2009081561 2008111148 2008120655 2008111270 2009090939 2008111269 2008120946 2008120222 2009101695 2008120219 2008121120 2008120223 2009110293 2008120220 200812C091 2008120656 2010011405 2008120651 200812C235 2008120947 2010012934 2008120652 2009010204 2008121121 2010022294 2008120653 2009010205 2009010334 2010030396 2008120654 2009010332 2009011377 2010031095 2008120945 2009010333 2009020247 2010032967 200812C034 2009011124 2009020248 2010032968 2009010331 2009011375 2009020249 201003C057 2009010878 2009011376 2009030485 2010062163 2009011123 2009020648 2009030776 201007C041 2009011374 2009020834 2009031075 2010081967 2009020246 2009021163 2009031076 2010090957 2009020638 2009030192 2009031077 2010100006 2009021162 2009030193 2009040064 201010C069 2009030250 2009030194 2009040675 2010111455 2009030772 2009030195 2009050705 2010120043 2009030773 2009030251 2009050941 2011020616 2009030774 2009030775 2009050942 2011021651 200903C057 2009040063 2009050998 2011041265 200903R025 2009041173 2009051344 2011051033 200903R030 2009050995 2009060918 2011051682 200903R035 2009050996 2009061499 2011101554 200903R040 2009050997 200906R208  200903R045 2009051342 2009070274  2009040062 2009051343 2009081544  2009040672 2009060245 2009081945  2009040673 2009060246 2009090203  2009040674 2009060470 2009091612  2009041172 2009060472 2009100215  200904C030 2009060473 2009100554  200904C123 2009060939 2009101095  200904R050 2009061237 2009101675  200904R055 2009061238 2009101676  200904R060 200906C002 200910C010  2009050079 200906R207 200910C054  2009050082 2009070534 2009112099  2009050083 2009071386 200911C079  2009050084 200907C086 2010012829  2009050085 2009081543 201001C059  2009050309 2009081944 2010020281  2009050648 2009090202 2010020282  2009050994 2009090681 2010022246  200905C081 2009090933 2010022247  200905C096 200909C002 2010022248  2009061236 200909C034 2010022249  2009061498 200909C092 2010030378  200906R202 2009100214 2010031052  2009071385 2009100553 2010031053  200907C042 2009101094 2010032281  200907R005 2009101674 2010032953  200907R006 200910C145 2010040365  200907R007 2009110265 2010050496  200907R008 2009110956 2010062967  2009080482 2009111477 2010070064  2009080490 2009112098 2010071011  200908C078 2009120830 2010071501  2009090201 200912C087 2010080884  2009090680 2010012828 2010081078  2009091611 201001C058 2010081223  2009100213 2010020277 2010090001  2009100552 2010020278 2010090242  2009101093 2010020279 2010090436  200910C005 2010020280 2010090669  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2010031080  2011020026 2010031081  2011020062 201003C056  2011030825 2010040370  2011041041 2010040458  2011041267 2010041089  2011041465 2010060626  2011050074 2010062706  2011060372 2010070160  2011060859 2010070611  2011062803 2010071745  2011071398 2010072139  2011080777 2010072140  2011082055 2010081600  2011090569 201008C049  2011091020 2010091676  2011092197 2010091971  201110R022 2010100899  2010101092  2010101615  201010C035  2010110960  2010112165  2010112167  201011C094  201011C193  2010120294  2011011763  2011011939  2011021453  2011021649  2011030320  2011031882  2011040137  2011040417  2011040851  2011041467  2011050027  2011051325  2011052064  2011061343  2011062804  2011070974  2011071098  2011071399  2011071991  201107R032  2011080120  2011080342  2011080568  2011081973  201108C224  2011090702  2011091018  2011092199  2011101718  201110R048                                                         69324 69328 69331 69528 2008101247 2008101162 2008101160 201011C182 200810C099 2008101352 2008110383 2010081969 200810C232 200810C120 2008110477 2010080182 200810C233 200810C121 2008111277 2010031097 2008110330 2008110005 200811C070 2010022295 2008110411 2008110261 2008120235 2010012935 2008110474 2008110319 2008120964 2009120940 2008110475 2008110331 2008121083 2009070627 2008110618 2008110332 200812C146 2009050721 2008111027 2008110476 2009010223 2009021172 2008111028 2008111030 2009010376 2009021171 2008111029 2008111031 2009011395 2008111032 2008111105 2008111274 2009020267 200812C236 2008111256 2008111275 2009020668 2008111158 200811C206 2008111276 200902C078 201107C058 2008120665 200811C095 2009030495 2011062723 2008120666 200811C207 2009030793 2011060952 2008120667 2008120233 2009040078 2011021707 2008120668 2008120234 2009040701  2008120959 2008120669 200904R086  2008120960 2008120670 2009050718  2008120961 2008120671 2009051017  200812C014 2008120962 2009051018  200812C063 2008120963 2009051357  200812C093 200812C232 2009060259 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  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including Puerto Rico and the Virgin Islands and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Bangladesh, Barbados, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macau, Macedonia, Malaysia, Mauritius, Mexico, Montenegro, Morocco, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Suriname, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Viet Nam, and Yemen.
  • Description du dispositif
    Medtronic DLP, DLP Single Stage Venous Cannula w/Right Angle Metal Tip. || Rx Only, Sterile EO, Nonpyrogenic. Model number #'s : || 67312, 67314, 67316, 67318, 67320, 69312, 69314, 69316, 69318, 68320, 69322, 69324, 69328, 69331, 69424, 69428, 69431, 69528, 69531. || These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to six hours or less.
  • Manufacturer
    Medtronic Inc. Cardiac Rhythm Disease Management

Manufacturer

Medtronic Inc. Cardiac Rhythm Disease Management
  • Adresse du fabricant
    Medtronic Inc. Cardiac Rhythm Disease Management, 8200 Coral Sea St. N.E., Saint Paul MN 55112
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA