Events

Recall of Zenith Alpha Thoracic Endovascular Graft

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by William A Cook Australia Pty Ltd.

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
    RC-2015-RN-00101-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-02-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00101-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Cook medical is informing their customers that additional warnings and precautions are being implemented in the instructions for use (ifu) for the zenith alpha thoracic endovascular graft. the updates to the ifu are being made to emphasise 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.
  • Action
    Cook Medical is notifying surgeons and hospitals of the updated information in the package insert. Surgeons are advised that patients already implanted with the device should receive additional surveillance and treatment where required. Further information can be found on the TGA web site at https://www.tga.gov.au/alert/zenith-alpha-thoracic-endovascular-graft. This action has been closed-out on 15/02/2017.

Device

Zenith Alpha Thoracic Endovascular Graft

Manufacturer

William A Cook Australia Pty Ltd