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 Abiomed, Inc. Automated Impella Controller (AIC) [Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems (cardiovascular); Product Code 0042-0000-US UDI-DI 00813502010022; Product Code 0042-0010-US UDI-DI 00813502010985; Product Code 0042-0040-US UDI-DI 00813502011401; Software Versions V8.4 and V8.4.1] [HKMD Number: 180162].
According to the FDA, it was a retrospective reporting for the release of Technical Bulletin IMP-2643 AIC Version 8.5 software update available. The update resolved an issue in version 8.4 where a pump was not recognized by the AIC.
For further information, please visit https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=93876
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 26 Feb 2024