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 St. Jude Medical Cardiac Rhythm Management Division Merlin@home Transmitter and Merlin@home with the MerlinOnDemand capability Transmitter [HKMD No.: 100350].
According to the FDA, due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download.
For further information, please visit: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=95557
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 28 November 2024