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. Arterial Cannulae, Clearview Blower/Mister, DLP Coronary Ostial Cannulae, I.M.A. Cannulae, Left Heart Vent Catheters, Tourniquet Sets, Vessel Cannulae, Aortic Root Cannulae and Cardioplegia Needles, Cardioplegia Adapters, Disposable Pressure Display Sets, Intracoronary Shunts, Suction Tubes, Venous Cannulae [Multiple model numbers; Multiple lot numbers] [HKMD No.: 150225].
According to the FDA, there is potential for unsealed sterile packing.
For further information, please visit https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=94274
If you are in possession of the affected products, please contact your supplier for necessary actions.
Identified on 13 May 2024
Updated on 14 May 2024