Recall of Berman Angiographic Balloon Catheters

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Mayo 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-2013-RN-00058-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-02-01
  • Event Country
  • Event Source
    DHTGA
  • Event Source URL
  • 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
    The labelling for the affected product numbers formerly referenced renografin-76 contrast medium (viscosity of 8.4 centipoise), which is no longer available. the manufacturer is currently in the process of updating the labelling and instructions for use (ifu) for these products.
  • Action
    Mayo Healthcare is providing an alert card within the product packaging recommending the use of contrast medium with a viscosity of 8.4 centipoise or lower.

Device

  • Model / Serial
    Berman Angiographic Balloon CathetersPart numbers: AI-07130, AI-07130-J, AI-07131, AI-07132, AI-07133, AI-07134, AI-07135, AI-07136, AI-07137, AI-07138ARTG Number: 123493
  • Manufacturer

Manufacturer