Recall Z-1175-2024 ยท OZD Temporary Non-Roller Type Left Heart Support Blood Pump
Abiomed, Inc.
Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems (cardiovascular)
| Date | Feb 22, 2024 (initiated Mar 1, 2021) |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 4,463 (US) |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.