Events

Recall of Edwards Lifesciences QuickDraw Venous Cannula

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-00524-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-05-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00524-1
  • 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 routine post market surveillance data review, edwards lifesciences has identified new risks associated with specific removal techniques for the quickdraw venous cannula product:1. scar tissue at the incision site may create resistance and increase the withdrawal forces on the cannula.2. when using the percutaneous technique; separation of the cannula may occur during removal if too much compressive force is applied at the incision site. this is in addition to the resistance felt if scar tissue is present.
  • Action
    Edwards Lifesciences is asking customers to quarantine any affected product and return these. Cautions for these new risks are being added to the IFU for future shipments of the cannula to provide information to users about this potential risk.

Device

Edwards Lifesciences QuickDraw Venous Cannula

Manufacturer

Edwards Lifesciences Pty Ltd