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 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-2013-RN-00126-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-02-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00126-1
  • 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 potential for the rear portion of the hvad pump's driveline connector housing partially or fully separating from the front portion of the driveline connector. if unattended, the electrical connection to the controller could be affected and loss of mechanical circulatory support may occur.
  • Action
    HeartWare are advising medical practitioners to inspect the patients drive line connector at each routine clinic visit. If the rear portion of the driveline connector housing is partially separated from the front portion, hand tighten the front and rear portions together. Contact your HeartWare Representative to arrange for an inspection and permanent repair by a HeartWare Clinical Engineer. If the driveline connector housing is completely separated secure the driveline connector housing to the controller with a splint to maintain a secure connection until a repair can occur. Where the connector/controller connection is secured by splinting the controller and connector with tongue depressors and electrical tape. Contact your HeartWare Representative to arrange for an inspection and permanent repair by a HeartWare Clinical Engineer. Further information can be found ont he TAG website at https://www.tga.gov.au/alert/heartware-ventricular-assist-system

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)Product Code: 1100, 1101, 1102, 1104, 1205Serial Numbers: HW001 to HW3827 and HW10000 to HW10675ARTG Number: 181875
  • Product Classification
    Cardiovascular Devices
  • 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