Events

Recall of SynCardia Freedom Driver System (a component of the SynCardia temporary Total Artificial Heart System)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Device Technologies 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-01528-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-12-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01528-1
  • 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
    Syncardia has updated the freedom driver system manuals and labelling to strengthen existing labelling content with regard to freedom driver drops, rough handling and exposure to liquid/debris. the freedom driver system manuals have been updated as follows: - advising patients to switch from their primary freedom driver to their backup freedom driver in the event their freedom driver is dropped, subjected to rough handling or exposed to liquid/debris. - adding more detailed information regarding the definition of rough handling. - advising hospital clinicians, patients and their caregivers to clean the freedom driver and drivelines only with a cloth lightly dampened with water. - advising hospital clinicians to refresh patient and caregiver training at every clinic visit.
  • Action
    Device Technologies is providing users with updated manuals.

Device

SynCardia Freedom Driver System (a component of the SynCardia temporary Total Artificial Heart Sy...
  • Model / Serial
    SynCardia Freedom Driver System (a component of the SynCardia temporary Total Artificial Heart System)Product Code: SYN-595000-001Supplied through Clinical Trial and SAS Category A
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd