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 ev3, Inc. (Medtronic Inc.) Protege GPS Self-Expanding Peripheral Stent System [Product number: SERB65-09-60-80, Sterile; Lot number B644679, UDI-DI: 00643169728974] [HKMD No.: 180297].
According to the FDA, seal defects could compromise the ability of the product packaging to maintain sterility.
For further information, please visit https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=93558
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 4 Jan 2024