medical Class II Updated 2024-02-28

Abiomed, Inc. recalls Automated Impella Controller (AIC), Product No. 0042-0000-US

Recalled Product

Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems (cardiovascular)

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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
View official government recall

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