Z-1175-2024 Class II Terminated
FDA device recall Z-1175-2024 was initiated by Abiomed, Inc. on March 1, 2021 and is designated Class II. 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… The recall status is terminated (terminated March 6, 2025). Affected quantity: 4,463 (US).
Recall Details
- Product Type
- Devices
- Report Date
- February 28, 2024
- Initiation Date
- March 1, 2021
- Termination Date
- March 6, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,463 (US)
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.
Distribution Pattern
US Nationwide distribution.
Code Information
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