Events

Recall of Edwards Lifesciences Fem-Flex II Cannulae

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-2014-RN-00422-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-04-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00422-1
  • 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
    Edwards lifesciences has received five complaints globally in the last four months involving the separation of dilator tips on specific models of fem-flex ii arterial cannula sizes 16, 18 and 20 french. some of the reported events involved separation of the tip of the dilator and required retrieval through an interventional radiologic procedure.
  • Action
    Edwards is requesting hospitals to quarantine and return the affected devices immediately.

Device

Edwards Lifesciences Fem-Flex II Cannulae

Manufacturer

Edwards Lifesciences Pty Ltd