Events

Recall of ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT - PROXIMAL TAPERED COMPONENT

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
    28635
  • Event Risk Class
    III
  • Event Initiated Date
    2015-02-03
  • 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
    Field safety notice advising users of updates to the ifu that are being made to emphasize best practices in response to a few recent findings of distal type i endoleak migration and aneurysm growth during on going longer-term follow-up of patients enrolled in the multi-national clinical investigation of the device.

Device

ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT - PROXIMAL TAPERED COMPONENT
  • Model / Serial
    Model Catalog: ZTA-PT-34-30-161 (Lot serial: all); Model Catalog: ZTA-PT-32-28-178 (Lot serial: all); Model Catalog: ZTA-DE-46-97 (Lot serial: all); Model Catalog: ZTA-DE-46-151 (Lot serial: all); Model Catalog: ZTA-DE-44-97 (Lot serial: all); Model Catalog: ZTA-DE-44-151 (Lot serial: all); Model Catalog: ZTA-DE-42-94 (Lot serial: all); Model Catalog: ZTA-DE-42-146 (Lot serial: all); Model Catalog: ZTA-DE-40-91 (Lot serial: all); Model Catalog: ZTA-DE-40-141 (Lot serial: all); Model Catalog: ZTA-DE-38-91 (Lot serial: all); Model Catalog: ZTA-DE-38-141 (Lot serial: all); Model Catalog: ZTA-DE-36-160 (Lot serial: all); Model Catalog: ZTA-DE-36-112 (Lot serial: all); Model Catalog: ZTA-DE-34-160 (Lot serial: all); Model Catalog: ZTA-DE-34-112 (Lot serial: all); Model Catalog: ZTA-DE-32-154 (Lot serial: all); Model Catalog: ZTA-DE-32-108 (Lot serial: all); Model Catalog: ZTA-DE-30-154 (Lot serial: all); Model Catalog: ZTA-DE-30-108 (Lot serial: all); Model Catalog: ZTA-DE-28-154 (Lot serial: all); Model Catalog:
  • Product Description
    z.alpha thor. endo.graft proximal tapered
  • Manufacturer
    COOK (CANADA) INC.

Manufacturer

COOK (CANADA) INC.