Events

Recall of Bard Rival PTA Catheters

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Bard Australia 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-00602-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-07-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00602-1
  • 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
    A portion of the affected lot contains units with an incorrect compliance card affixed to the catheter hoop inside the product pouch. specifically, the incorrect 7mm compliance card contains the incorrect balloon diameter, lengths, diameter growth (compliance), and rated burst pressure (rbp) information instead of the correct 6mm compliance card.
  • Action
    End users are advised of the labelling issue and provided with the correct compliance card. Bard is recommending that the affected stock is isolated and that this letter is placed in a prominent positon with the isolated stock.

Device

Bard Rival PTA Catheters
  • Model / Serial
    Bard Rival PTA Catheters Product code RV135610 lot # GFYG3726 onlyARTG#: 172107
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd