Events

Recall of ATTAIN HYBRID Guide Wires (used to aid the placement of Medtronic transvenous left ventricular leads in the coronary vasculature)

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-2013-RN-01086-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-10-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01086-1
  • 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 identified the potential for an issue with a specific subset of batch numbers of the guide wires where the ptfe (polytetrafluoroethylene) coating could delaminate and detach from the guide wire. this issue affects a subset of a range of guide wires manufactured from mid-april 2013. delamination and detachment of the ptfe coating may lead to embolic occlusion and thrombosis in coronary, cerebral, peripheral or pulmonary vasculature. vascular thrombosis and/or occlusion have the potential to result in irreversible damage or injury to vital organs including myocardial infarction or stroke.
  • Action
    Customers are asked to quarantine all unused product for return to Medtronic. For affected products that have been used, Medtronic is advising that patients should continue to be managed in accordance with hospitals standard patient management protocol.

Device

ATTAIN HYBRID Guide Wires (used to aid the placement of Medtronic transvenous left ventricular le...
  • Model / Serial
    ATTAIN HYBRID Guide Wires (used to aid the placement of Medtronic transvenous left ventricular leads in the coronary vasculature)Model GWR419688Batch Numbers: 0006840866, 0006840879, 0006873688ARTG Number: 153354
  • 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