Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular
FDA device recall Z-1175-2024 · posted 2024-02-22 · Terminated
Recall details
- Recalling firm
- Abiomed, Inc.
- 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.
- Action taken
- This is a retrospective report for the March 2021 Technical Bulletin, which described a Product Update; specifically the AIC Version 8.5 Software Update. The software update began rollout on March 4, 2021. According to the firm, Version 8.5 of the software contained bug fixes for the issues seen in version 8.4. The technical bulletin was posted to HeartRecovery.com on March 5, 2021.
- Root cause
- Software design
- Status
- Terminated
- Product code
- OZD
- Quantity affected
- 4,463 (US)
- Distribution
- US Nationwide distribution.
- Date initiated
- 2021-03-01
- Date posted
- 2024-02-22
- Date terminated
- 2025-03-06
- Location
- Danvers, MA
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