Events

Rappel de ZENITH ALPHA ABDOMINAL ENDOVASCULAR GRAFT

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par COOK (CANADA) INC..

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
    35462
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2014-04-28
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 recall data from the U.S. and Canada.
  • Notes supplémentaires dans les données
  • Cause
    Involve difficulty deploying the graft from the delivery system and/or using the handle portion of the device. no adverse events have been experienced/reported though the potential for adverse events due to deployment difficulties includes additional intervention up to and including open surgical repair. this failure mode applies only to the delivery system and not the implantable stent graft portion of the device. previously implanted grafts are not affected.

Device

ZENITH ALPHA ABDOMINAL ENDOVASCULAR GRAFT
  • Modèle / numéro de série
    Model Catalog: ZIMB-32-98 (Lot serial: F4779612); Model Catalog: ZIMB-36-108 (Lot serial: F4779612); Model Catalog: ZIMB-32-108 (Lot serial: F4779612); Model Catalog: ZIMB-36-128 (Lot serial: F4779629); Model Catalog: ZIMB-36-118 (Lot serial: F4779629); Model Catalog: ZIMB-36-108 (Lot serial: F4779629); Model Catalog: ZIMB-32-98 (Lot serial: F4779629); Model Catalog: ZIMB-32-84 (Lot serial: F4779629); Model Catalog: ZIMB-32-108 (Lot serial: F4779629); Model Catalog: ZIMB-36-128 (Lot serial: F4779628); Model Catalog: ZIMB-36-118 (Lot serial: F4779628); Model Catalog: ZIMB-36-108 (Lot serial: F4779628); Model Catalog: ZIMB-32-98 (Lot serial: F4779628); Model Catalog: ZIMB-32-84 (Lot serial: F4779628); Model Catalog: ZIMB-32-108 (Lot serial: F4779628); Model Catalog: ZIMB-36-128 (Lot serial: F4779632X); Model Catalog: ZIMB-36-118 (Lot serial: F4779632X); Model Catalog: ZIMB-36-108 (Lot serial: F4779632X); Model Catalog: ZIMB-32-98 (Lot serial: F4779632X); Model Catalog: ZIMB-32-84 (Lot serial: F4779632X); Model
  • Description du dispositif
    ZENITH ALPHA ABDOMINAL ENDOVASCULAR GRAFT
  • Manufacturer
    COOK (CANADA) INC.

Manufacturer

COOK (CANADA) INC.