Events

Recall of HeartWare Ventricular Assist Device (HVAD) System HeartWare HVAD Pump Implant Kit

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-01090-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-08-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01090-1
  • 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 identified that specified implant kit pumps may be more susceptible to electrical faults (and connection failures) if the driveline that connects the pump to the controller becomes contaminated. contamination can occur during the implant procedure or post operatively from fluid ingress into the driveline, and occurs most often in the first 30 days post implant. potential risks include interruption of circulatory support due to a pump stop.The reported complaint rate for this contamination is approximately 5.0% of all units sold; however, the actual occurrence rate of serious injury associated with the failure is approximately 1.06%. the majority of reported injuries were categorised as serious due to prophylactic hospitalisation for the cleaning procedure with or without associated medical intervention.Heartware has implemented manufacturing process improvements to prevent driveline connector contamination in new implant kits.
  • Action
    HeartWare is advising clincians that patients with implanted devices that experience electrical faults due to driveline connector contamination should see a medium alert on their controller display. In this case, the clinician should contact their HeartWare representative promptly to schedule a driveline connector cleaning procedure by a qualified HeartWare technician, as described in HeartWare Ventricular Assist System Instructions for Use, section 3.24. Do not attempt to repair or service any components of the HeartWare System. For devices that have not been implanted, clinicians are advised to identify affected product with HeartWare, who will provide replacement devices and arrange for the return of the affected product. This action has been closed-out on 04/05/2017.

Device

HeartWare Ventricular Assist Device (HVAD) System HeartWare HVAD Pump Implant Kit
  • Model / Serial
    HeartWare Ventricular Assist Device (HVAD) SystemHeartWare HVAD Pump Implant KitModel Number: 1104Serial Number: Serial numbers lower than HW25838ARTG 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