Events

Recall of FlexTherm Heater Cooler Device

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by LivaNova Australia 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-2017-RN-00252-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-03-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00252-1
  • 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
    After a thorough review of the flextherm heater cooler design, which has been marketed since june 2015 livanova has come to conclusion that the design concept does not fully meet user requirements. livanova has discontinued the production of the flextherm and does not intend to offer it again to the market in the future.
  • Action
    A LivaNova representative will contact the customer to agree on the return of the affected product. LivaNova will replace the affected product with a heater cooler HC3T including new connectors and tubing at no charge. Customers may continue to safely use the heater cooler devices in accordance with the Operator’s Manual and the supplied instructions below until the necessary device removal has been completed.

Device

FlexTherm Heater Cooler Device
  • Model / Serial
    FlexTherm Heater Cooler DeviceProduct Code: 16-70-00Affected Serial Number in Australia: 16E01091ARTG Number: 194514
  • Manufacturer
    LivaNova Australia Pty Ltd

Manufacturer

LivaNova Australia Pty Ltd