Events

Recall of ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT - DISTAL 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
    120539
  • Event Risk Class
    I
  • Event Initiated Date
    2017-06-23
  • 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
    William cook europe aps has learned of an issue affecting the zenith alpha thoracic endovascular grafts. as described in the recent field safety notice 2017fa0001 of march 2017 regarding the zenith alpha thoracic endovascular graft there were complaints involving thrombosis/occlusion of the product when used to treat blunt thoracic aortic injury (btai). since that time cook medical has received additional complaints for the same problem. although the complaints were from patients treated prior to issuance of the above noted field safety notice cook medical is initiating a voluntary correction of the instructions for use (ifu) and is also voluntarily removing specific sizes of the zenith alpha thoracic endovascular graft from the market. the manufacturer is voluntarily removing the indication for blunt thoracic aortic injury. the specific sizes of 18-22 mm used for the btai indication is being recalled from the market and will no longer be available. the instructions for use (ifu) will be corrected for the remaining sizes on the market used for endovascular treatment of patients with isolated lesions of the descending thoracic aorta.

Device

ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT - DISTAL COMPONENT
  • Model / Serial
    Model Catalog: ZTA-DE-26-104 (Lot serial: ALL); Model Catalog: ZTA-D-46-211 (Lot serial: ALL); Model Catalog: ZTA-D-44-211 (Lot serial: ALL); Model Catalog: ZTA-D-42-204 (Lot serial: ALL); Model Catalog: ZTA-D-40-197 (Lot serial: ALL); Model Catalog: ZTA-D-40-147 (Lot serial: ALL); Model Catalog: ZTA-D-38-197 (Lot serial: ALL); Model Catalog: ZTA-D-36-190 (Lot serial: ALL); Model Catalog: ZTA-D-34-190 (Lot serial: ALL); Model Catalog: ZTA-D-32-160 (Lot serial: ALL); Model Catalog: ZTA-D-30-160 (Lot serial: ALL); Model Catalog: ZTA-P-46-233 (Lot serial: ALL); Model Catalog: ZTA-P-46-179 (Lot serial: ALL); Model Catalog: ZTA-P-46-152 (Lot serial: ALL); Model Catalog: ZTA-P-46-125 (Lot serial: ALL); Model Catalog: ZTA-P-44-233 (Lot serial: ALL); Model Catalog: ZTA-P-44-179 (Lot serial: ALL); Model Catalog: ZTA-P-44-125 (Lot serial: ALL); Model Catalog: ZTA-P-42-225 (Lot serial: ALL); Model Catalog: ZTA-P-42-173 (Lot serial: ALL); Model Catalog: ZTA-P-42-121 (Lot serial: ALL); Model Catalog: ZTA-P-40-217 (Lot se
  • Product Classification
    Cardiovascular Devices
  • Product Description
    ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT - DISTAL COMPONENT;ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT - PROXIMAL COMPONENT;ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT - PROXIMAL TAPERED COMPONENT
  • Manufacturer
    COOK (CANADA) INC.

Manufacturer

COOK (CANADA) INC.