Reported Dec 13, 2023 · Terminated
Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.
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 number 0042-040-US with software versions V8.4 and V8.4.1.
- Lot codes and dates
- UDI-DI (GTIN)
00813502011401serial numbers IC8386IC8391 and IC8617
- UDI-DI (GTIN)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Pump not detected as connected to controller due to software issue.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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