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 United States Food and Drug Administration (FDA) has posted a medical device safety alert concerning Medtronic Inc. Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator [Product number: DDPA2D1] [HKMD numbers: 200462].
According to the FDA, during internal review of Polaris battery assembly data from the HiPot operation, a test systems engineer noticed that some batteries had gone through the High Potential test twice. This was able to occur because the test screen did not prevent retesting after a failure. Some batteries were therefore retested and passed.
For further information, please visit https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=93663
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 25 Jan 2024