Events

Recall of Edwards Fem-Flex II Femoral Arterial Cannula, sizes 8, 10 & 12 French

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-2015-RN-00294-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-03-31
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00294-1
  • 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, edwards lifesciences has identified a potential health risk to patients regarding the use of fem-flex ii femoral arterial cannula, sizes 8, 10, and 12 french only. edwards has received one customer complaint regarding a released wire, located at the tip area of the cannula, which was identified prior to use. although the condition does not affect the functionality of the cannula, there is potential patient safety risk if a protruding wire is not detected prior to use. in a worst-case scenario, if the physician attempted to insert the device, the exposed wire could damage the femoral artery, causing a vascular injury that could require surgical or interventional repair.While there have been no reports of injury associated with this issue, edwards is taking this action to eliminate the chance of tissue damage caused by a protruding wire.
  • Action
    All affected product is being Recalled from the Market. This action has been closed-out on 17/08/2016.

Device

Edwards Fem-Flex II Femoral Arterial Cannula, sizes 8, 10 & 12 French
  • Model / Serial
    Edwards Fem-Flex II Femoral Arterial Cannula, sizes 8, 10 & 12 FrenchProduct Codes: FEMII008A, FEMII008AT, FEMII010A, FEMII010AT, FEMII012A & FEMII012ATARTG Number: 177959Product Codes: FEMII008V, FEMII010V & FEMII012VARTG Number: 142782Multiple lot numbers affectedARTG number: 142782
  • Manufacturer
    Edwards Lifesciences Pty Ltd

Manufacturer

Edwards Lifesciences Pty Ltd