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Abiomed, Inc. recalls Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular
Recalled February 28, 2024 · FDA recall Z-1175-2024 · Abiomed
Hazard
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. · FDA Class II
Units
4,463 (US)
Sold at
US Nationwide distribution.
Description
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.
Product
Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems (cardiovascular)
Manufacturer(s)
Abiomed, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →