Events

Recall of Anastaflo Intravascular Shunt ( Carotid artery shunt)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Edwards Lifesciences 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-2013-RN-00810-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-08-01
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00810-1
  • 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
    Through post market surveillance data review, edwards lifesciences has identified a potential health risk to patients undergoing by-pass surgery when an anastaflo intravascular shunt is used. edwards has received twenty-three complaints concerning excessive adhesive on the shunt body that may interfere with suturing of by-pass grafts. there have been no reports of injuries in any of these complaints. no events have been reported in australia.
  • Action
    Customers are asked to quarantine affected stock and return all devices with remaining shelf life to Edwards Lifesciences. Customers can contact Edwards Lifesciences to obtain replacement product.

Device

Anastaflo Intravascular Shunt ( Carotid artery shunt)

Manufacturer

Edwards Lifesciences Pty Ltd