Events

Recall of HeartWare Controller (Ventricular assist device)

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-00001-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-01-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00001-1
  • 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
    In 2013, heartware advised clinicians (tga reference: rc-2013-rn-00438-1) on measures to take in relation to patient safety risks associated with electrostatic discharge (esd) following two incidents of patient deaths where the electrostatic discharge (esd) was suspected to cause or contribute to data corruption in the pump motor controller resulting in a loss of commutation.The risk of injury associated with esd includes the interruption of circulatory support due to a pump stop. since the 2013 field safety corrective action, heartware have received reports of one additional death and one additional serious injury in which esd may have caused or contributed to data corruption in older controllers resulting in the loss of commutation to pump motors, which ultimately led to pump stops. the affected controllers exhibit a higher susceptibility to esd than newer controllers.
  • Action
    Clinicians are requested to inspect inventory and quarantine all affected controllers. For patients who possess affected Controllers (both primary and backup) Clinicians are advised as follows: (a). For Primary Controllers: Review the applicable risks and if medically advisable, exchange the affected Controller under medical supervision with a new Controller (serial number CON005473 or higher). (b). For Backup Controllers: Contact the patient and arrange to have the backup Controller replaced with a new Controller (serial number CON005473 or higher). A HeartWare representative will contact the clinicians to assist with this process and to help replace affected Controllers where necessary. This action has been closed-out on 14/07/2016.

Device

HeartWare Controller (Ventricular assist device)
  • Model / Serial
    HeartWare Controller (Ventricular assist device)Product Codes:1400, 1401XXRange of Serial Numbers: CON000001 through CON005472ARTG 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