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 Biosense Webster, Inc. CARTO VIZIGO Bi-Directional Guiding Sheath [Product No.:D-1385-02; UDI-DI code: 10846835016277; Lot Numbers: 60000282] [HKMD number: 220208].
According to the FDA, due to a manufacturing issue, device under process validation phase were inadvertently mixed into the main manufacturing process.
For further information, please visit https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=94014
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 15 Mar 2024