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 Boston Scientific Corporation EMBLEM S-ICD Pulse Generator [Model: A209, A219] [HKMD No.: 150324].
According to FDA, there is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, which may cause S-ICD sensing disablement for a 24-hour interval.
For further information, please visit https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=92760
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 24 Aug 2023