Events

Recall of Cook Medical Zilver PTX Drug-Eluting Peripheral Stent (peripheral artery stent)

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-2012-RN-01282-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2012-12-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01282-1
  • 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 has received reports of delivery system catheter fractures resulting in tip separation after deployment.This action was undertaken prior to seeking agreement with the tga.
  • Action
    Cook Medical is updating the Instructions for Use (IFU) to mitigate the risk of the delivery system catheter fracturing

Device

Cook Medical Zilver PTX Drug-Eluting Peripheral Stent (peripheral artery stent)

Manufacturer

William A Cook Australia Pty Ltd