Recall Z-1175-2024— Abiomed, Inc.

Name: FDA recall Z-1175-2024
Creator: U.S. Food and Drug Administration
Published: 2021-03-01

Class II · Terminated

Class II FDA medical device recall by Abiomed, Inc., initiated 2021-03-01, terminated 2025-03-06. FDA's recall record names no specific 510(k) clearance for this event. Product: Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems (cardiovascular). Reason: 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..

Recalling firm: Abiomed, Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-03-01
Terminated: 2025-03-06
Firm location: Danvers, MA, United States

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.