Events

Recall of ZENITH ALPHA ABDOMINAL ENDOVASCULAR GRAFT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by COOK (CANADA) INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    35462
  • Event Risk Class
    II
  • Event Initiated Date
    2014-04-28
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
    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
  • Product Description
    ZENITH ALPHA ABDOMINAL ENDOVASCULAR GRAFT
  • Manufacturer
    COOK (CANADA) INC.

Manufacturer

COOK (CANADA) INC.