Events

Recall of HeartWare Ventricular Assist System (intended for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end stage heart failure)

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-2013-RN-01323-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-12-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01323-1
  • 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
    Subsequent to a urgent recall for product correction (tga ref: rc-2013-rn-00126-1) of hvad pump's driveline connector housing become partially or fully separated from the front portion of the driveline connector, heartware have identified an alternative failure mechanism. in 8 cases, customers have reported that the locking mechanism of the driveline connector has failed to engage. there have been no reports of injury. heartware has made changes to the manufacturing procedures to address this issue.
  • Action
    Heartware is advising users that should the driveline disconnect from the controller, push the driveline connector back into the controller immediately and contact Heartware for repair.. Heartware is advising clinicians to inspect patient's driveline connector as described in the provided technical bulletin for proper locking. For already implanted patients, please arrange a follow up visit at the earliest convenience to check the patient's driveline connector. If the locking mechanism of the driveline connector is found to have failed to engage, please push the connector back into the controller and contact Heartware for repair.

Device

HeartWare Ventricular Assist System (intended for use as a bridge to cardiac transplantation in p...
  • Model / Serial
    HeartWare Ventricular Assist System (intended for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end stage heart failure)Catalogue Numbers: 1100, 1101, 1102, 1103, 1104 & 1205Serial Numbers: HW001 to HW11215 and HW20001 to HW20296ARTG Number: 181875
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Heartware Pty Ltd

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