Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
The Australian Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning HeartWare Inc HeartWare Ventricular Assist Device (HVAD) Systems [Product Code: 1104] [HKMD No.: 180485].
According to the TGA, the manufacturer is providing a follow-up to previous communications, where the manufacturer communicated that an identified subpopulation of HeartWare Ventricular Assist Device (HVAD) Systems may experience a delay to restart or failure to restart at a higher rate than the overall population of HVAD Systems.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00761-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 28 Aug 2023