Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems (cardiovascular)
Reported: February 28, 2024 Initiated: March 1, 2021 #Z-1175-2024
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.
Details
- Recalling Firm
- Abiomed, Inc.
- Units Affected
- 4,463 (US)
- Distribution
- US Nationwide distribution.
- Location
- Danvers, MA
Frequently Asked Questions
What product was recalled? ▼
Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems (cardiovascular). Recalled by Abiomed, Inc.. Units affected: 4,463 (US).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 28, 2024. Severity: Moderate. Recall number: Z-1175-2024.
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