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
    49223
  • Event Risk Class
    II
  • Event Initiated Date
    2017-03-22
  • 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
    A new ifu has been approved with updated information. the updates to the ifu are of key importance when using the device to treat blunt thoracic aortic injury (btai) which is now covered under the newly approved indication for isolated lesions of the descending thoracic aorta. this safety communication is for informational purposes only and no devices need to be returned.

Device

ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT - PROXIMAL TAPERED COMPONENT
  • Model / Serial
    Model Catalog: ZTA-PT-32-28-178 (Lot serial: >10 contact mfr); Model Catalog: ZTA-P-46-233 (Lot serial: >10 contact mfr); Model Catalog: ZTA-P-46-179 (Lot serial: >10 contact mfr); Model Catalog: ZTA-P-46-125 (Lot serial: >10 contact mfr); Model Catalog: ZTA-P-44-233 (Lot serial: >10 contact mfr); Model Catalog: ZTA-P-44-179 (Lot serial: >10 contact mfr); Model Catalog: ZTA-P-44-125 (Lot serial: >10 contact mfr); Model Catalog: ZTA-P-42-225 (Lot serial: >10 contact mfr); Model Catalog: ZTA-P-42-173 (Lot serial: >10 contact mfr); Model Catalog: ZTA-P-42-121 (Lot serial: >10 contact mfr); Model Catalog: ZTA-P-40-217 (Lot serial: >10 contact mfr); Model Catalog: ZTA-P-40-167 (Lot serial: >10 contact mfr); Model Catalog: ZTA-P-40-117 (Lot serial: >10 contact mfr); Model Catalog: ZTA-P-38-217 (Lot serial: >10 contact mfr); Model Catalog: ZTA-P-38-167 (Lot serial: >10 contact mfr); Model Catalog: ZTA-P-38-117 (Lot serial: >10 contact mfr); Model Catalog: ZTA-P-36-209 (Lot serial: >10 contact mfr); Model Catalog: Z
  • Product Description
    zenith A.T.E. proximal tapered component;zenith A.T.E. proximal component;zenith A.T.E. distal component
  • Manufacturer
    COOK (CANADA) INC.

Manufacturer

COOK (CANADA) INC.