Class II

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

Abiomed, Inc. · March 1, 2021

Reason for Recall

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.

Distribution

US Nationwide distribution.

States Affected

NATIONWIDE

Quantity Affected

4,463 (US)

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1175-2024

Status: terminated

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