Events

Recall of HeartWare HVAD System

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Heartware 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-00370-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-05-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00370-1
  • 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
    Heartware is providing further information to users regarding:1. worn alignment guides, 2. internal "double disconnect alarm" battery, 3. power management software upgrade, 4. driveline outer sheath discoloration & cracking, and 5. snagging or pulling of the driveline.
  • Action
    HeartWare is reiterating warnings and precautions stated in the Instructions for Use and Operators Manual to ensure the safe use of the devices. HeartWare is also notifying health care professionals of an additional warning regarding discolouration and cracking of the drive line due to exposure to UV light. Further information can be found ont he TAG website at https://www.tga.gov.au/alert/heartware-ventricular-assist-system

Device

HeartWare HVAD System

Manufacturer

Heartware 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