Events

Rappel de Acrobat V Vacuum OffPump System

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 Maquet Cardiovascular, LLC.

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
    69101
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0132-2015
  • Date de mise en oeuvre de l'événement
    2014-08-13
  • Date de publication de l'événement
    2014-10-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-03-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129643
  • 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
    stabilizer,heart - Product Code MWS
  • Cause
    An internal finding identified the presence of pinholes/cuts in some of the tyvek pouches of the vacuum tubing sets included as an accessory to acrobat v vacuum off-pump system, acrobat suv vacuum off-pump system, axius xpose 3 access device and xpose 4 access device.
  • Action
    Maquet Inc. issued Recall letters/Acknowledgement forms dated via Fed-Ex on 8/13/2014.

Device

Acrobat V Vacuum OffPump System
  • Modèle / numéro de série
    class I 510 K exempt  Acrobat V Vacuum Off-Pump System OM-9100S 25081832 25083629 25084722 25086515 25087723 25089063 25089942 25090685 25091907 25092783 25092968 25093960 25095207 25096649 25097068 25097679 25097895 25098213    Acrobat SUV Vacuum Off-Pump System OM-9000S  25083904 25084006 25084498 25084648 25084928 25085094 25085850 25086057 25086330 25086468 25086786 25086869 25087249 25087330 25087412 25087793 25088394 25088704 25089154 25089224 25089724 25090578 25090748 25090943 25091171 25092128 25092272 25092690 25092813 25093167 25093281 25094024 25094065 25094473 25094712 25094860 25095107 25095600 25095769 25096128 25096305 25096404 25096913 25097097 25097336 25097417 25097747 25097801 25098540 25098968   Axius Xpose 3 Access Device XP-3000 25063171 25063264 25064005 25064805 25065216 25066072 25066261 25067242 25067493 25067915 25068869 25070671 25071619 25072468 25073684 25075060 25077055 25077999 25078510 25078808 25080773 25081495 25082997 25084179 25086061 25087498 25088896 25090502 25090832 25091779 25092248 25092884 25093619 25094030 25095768 25096118 25096687 25097508 25098402 25098904    XPOSE 4 Access Device XP-4000  25063351 25063594 25064160 25064428 25064917 25065315 25065547 25067036 25067396 25068245 25068555 25069189 25069589 25069971 25070492 25070808 25071242 25072056 25072852 25073562 25074441 25075249 25075644 25076681 25077208 25077638 25078154 25079334 25079975 25080256 25080465 25081324 25081566 25081959 25083287 25083699 25084533 25085038 25085516 25085696 25086333 25086530 25087192 25088336 25088517 25089557 25089623 25090324 25090692 25091410 25091811 25092398 25092567 25093083 25093570 25094620 25094845 25095211 25095862 25097087 25097274
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and countries of: ARGENTINA, AUSTRIA, BANGLADESH, BELARUS, BRAZIL, BRUNEI, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, ECUADOR, GERMANY, FINLAND, FRANCE, GREECE, HONG KONG, INDICA, INDONESIA, ISRAEL, ITALY, JAPAN, MEXICO, MALAYSIA, NETHERLANDS, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAK REPUBLIC, SOUTH KOREA, SPAIN, SWITZERLAND, TAIWAN, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM AND VIETNAM.
  • Description du dispositif
    Acrobat V Vacuum Off-Pump System || OM-9100S || Acrobat SUV Vacuum Off-Pump System || OM-9000S || Axius Xpose 3 Access Device XP-3000 || XPOSE 4 Access Device XP-4000 || Acrobat V Vacuum Off-Pump System Each Acrobat V Vacuum Off-Pump system is intended for use during performance of cardiac surgical procedures through a sternotomy incision approach.
  • Manufacturer
    Maquet Cardiovascular, LLC

Manufacturer

Maquet Cardiovascular, LLC
  • Adresse du fabricant
    Maquet Cardiovascular, LLC, 45 Barbour Pond Dr, Wayne NJ 07470-2094
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    USFDA