Events

Recall of Amphirion Deep Percutaneous Transluminal Angioplasty (PTA) Balloon Dilation Catheter

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Medtronic Australasia 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-01048-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-10-26
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01048-1
  • 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
    The potential for a sterile breach in the pouch material was discovered during standard internal packaging tests. the pouch seal breach could potentially result in compromised sterility of the product. following the instructions for use (ifu) would reduce the risk of potential patient harm if issue was easily detectable but in most cases it is not. there have been no reports of adverse patient events related to this issue.
  • Action
    Customers are advised to remove and quarantine and return all units of the Amphirion Deep Balloon Catheter that remain in their inventory. Patients who have received treatment with an Amphirion Deep PTA Balloon Dilation Catheter affected by this recall should continue to be monitored in accordance with the standard practice. This action has been closed-out on 22/08/2016.

Device

Amphirion Deep Percutaneous Transluminal Angioplasty (PTA) Balloon Dilation Catheter
  • Model / Serial
    Amphirion Deep Percutaneous Transluminal Angioplasty (PTA) Balloon Dilation CatheterModel Numbers: AMD253210002, AMD025150152, AMD030120152 Lot Numbers: 209425769, 209436620, 209470464, 209470474, 209507756, 209553426, 209664051, 209722663, 209760068 ARTG Number: 154327
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia Pty Ltd
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DHTGA