Events

Recall of VASCU-GUARD Peripheral Vascular Patch, 0.8 x 8cm

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Baxter Healthcare 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-2016-RN-00879-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-07-01
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00879-1
  • 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
    Baxter healthcare is issuing a recall notice in response to post-marketing reports overseas received for the vascu-guard peripheral vascular patch. to date, baxter has received four post-marketing reports for the vascu-guard product for intraoperative or post-operative bleeding episodes, which required additional clinical intervention. at this point, it is unknown whether there is any causal relationship between vascu-guard and the reported events. in the interim, baxter is requesting that customers immediately discontinue the use of the identified product lots until the investigation has concluded.
  • Action
    Baxter is advising users to discontinue use, and return all affected stock.

Device

VASCU-GUARD Peripheral Vascular Patch, 0.8 x 8cm

Manufacturer

Baxter Healthcare Pty Ltd