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-2016-RN-00580-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-05-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00580-1
  • 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 have received reports of loose power and data connectors on the heartware controller, specifically for loose connector ports within the controller.If a power or data connector becomes loose, controllers could become more vulnerable to water damage, which could lead to internal corrosion, electrical issues, reduced speaker volume and connection failures.In these scenarios, potential risks include:- interruption of circulatory support due to a pump stop, which could cause serious injury or death- reduced ability to detect alarms- loss of communication between the controller and heartware monitor.
  • Action
    HeartWare is advising the clinicians to: 1. Continue to remind the patients currently supported by the HVAD System to follow all instructions in their Patient Manuals including alarm awareness, water avoidance and carefulness when connecting and disconnecting to power and data sources. 2. At the patients’ regularly-schedule appointments, inspect Controllers for loose connectors by gently pressing on each connector and feeling for atypical movement. Do not press hard on the connectors or they could break. If a loose connector is identified, it is recommended that the affected Controller be replaced with a Controller from inventory and contact the local HeartWare representative. If the affected Controller is the patient’s primary Controller, please use discretion as to whether the risks of a Controller exchange outweigh the risks of a Controller with a loose connector. This action has been closed-out on 22/02/2017.

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