Reported Feb 28, 2024 · Terminated
Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular…
Abiomed, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abiomed, Inc. · 24 Cherry Hill Dr · Danvers, MA · 01923-2575
Is this the product you have?
- Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems (cardiovascular)
- Lot codes and dates
- 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
- Amount recalled
- 4,463 (US)
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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