Events

Recall of HeartWare Sterile Surgical Tool Sets (Supplied as part of the HeartWare Ventricular Assist System, artifical heart (HVAS))

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Heartware Pty Limited.

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-2012-RN-01040-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2012-10-31
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01040-1
  • 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
    There is an error with labelling regarding the “use by date” of sterile surgical tool products (ref. cat # 1318). more specifically, some units were labelled with a “use by date” corresponding to 2-years shelf life instead of the approved 1-year shelf life.
  • Action
    The sponsor is advising users of changes to the approved use by date and is asking users to inspect current inventory and amend the use by dates of affected products.

Device

HeartWare Sterile Surgical Tool Sets (Supplied as part of the HeartWare Ventricular Assist System...
  • Model / Serial
    HeartWare Sterile Surgical Tool Sets (Supplied as part of the HeartWare Ventricular Assist System, artifical heart (HVAS))Catalogue Number: 1318Lot Number: 520863ARTG Number: 181875
  • Manufacturer
    Heartware Pty Limited

Manufacturer

Heartware Pty Limited
  • 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