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 its Medtronic Inc. (Medtronic Neuromodulation) SynchroMed II Infusion Pump [Product Number: 8637-20; GTIN Number: 00643169630505; Serial Number: NGP004814H] [HKMD No.: 090082].
According to the FDA, there is a potential for error and inability to interrogate pump due to data corruption in the pump memory.
For further information, please visit: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=95419
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 24 Oct 2024