Events

Recall of Euphora Semi-Compliant Rapid Exchange Balloon Dilatation 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-2017-RN-00862-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-07-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00862-1
  • 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
    Medtronic has received reports of difficulties in removing the stylette of the euphora semi-compliant rapid exchange (rx) balloon dilatation catheter. in the event that stylette removal difficulties are encountered, there is the potential for damage to the balloon or catheter due to excessive force being applied, and this may lead to balloon inflation or deflation challenges. potential risks associated with balloon inflation and deflation difficulties include prolonged procedure time and the need for additional intervention. in addition, inflation or deflation difficulties or catheter damage during procedural use could result in vessel occlusion or injury. medtronic has received one report of patient injury related to this matter.
  • Action
    Medtronic is requesting customers: 1. Identify and quarantine all unused affected product as listed in your inventory; 2. Return all unused, affected product listed in your inventory to Medtronic. Contact Customer Service on 1800 668 670 to initiate a product return and credit. Your Medtronic Representative can assist you in the return of affected product as necessary; and 3. Complete the supplied Customer Acknowledgement Form and fax it to Medtronic on 1800 929 645 to the attention of ANZ Regulatory Affairs or scan and email to rs.anzregaffairs@medtronic.com with TGA Ref # “RC-2017-RN-XXXXX-X” in the subject line.

Device

Euphora Semi-Compliant Rapid Exchange Balloon Dilatation Catheter
  • Model / Serial
    Euphora Semi-Compliant Rapid Exchange Balloon Dilatation CatheterLot Number range: 212553130 to 213283557Expiration Date range: 4 Jan 2019 to 9 May 2019Multiple Model NumbersARTG Number: 238388
  • 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