Events

Recall of IntraClude Intra-aortic Occlusion Device

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-2018-RN-00313-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2018-04-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00313-1
  • 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 identified a potential safety risk, which may occur during the use of the intraclude intra-aortic occlusion device (icf100). edwards lifesciences has received a limited number of reports (11 reports since december 2017, which is a rate of approximately 2%) regarding inflation fluid leaking out the distal open end of the strain relief. when present, this leak can be identified through normal monitoring of balloon pressure.
  • Action
    Edwards Lifesciences is advising users to maintain close vigilance of balloon pressure during a procedure in order to identify when additional volume is needed to maintain adequate occlusion. Consider having backup equipment available, such as aortic cross-clamps or additional IntraClude devices. Product return is not required at this time. Currently, unaffected product is not available.

Device

IntraClude Intra-aortic Occlusion Device

Manufacturer

Edwards Lifesciences Pty Ltd