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 Medtronic Inc. Cobalt XT HF Cardiac Resynchronization Therapy Defibrillator and Evera XT DR Defibrillator [HKMD No.: 200462, 140411].
According to the TGA, the manufacturer identified devices that may have undergone a specific manufacturing sequence that requires additional engineering evaluation. The specific sequence utilised a component lot obtained from a supplier, where a subset of this lot has the potential to be inconsistent with specification.
If this component were to fail, it may lead to an impact to device function and/or require device replacement.
For further information, please visit https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2024-RN-00312-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 23 Apr 2024