Reported Jun 3, 2026 · Ongoing
Automated Impella Controller (AIC); Product Code: 0042-0000-US;
Abiomed, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.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. · 22 Cherry Hill Dr · Danvers, MA · 01923-2575
Is this the product you have?
- Automated Impella Controller (AIC)
- Product Code0042-0000-US
- Lot codes and dates
- Product Code0042-0000-US
- UDI-DI00813502010022
- Serial Numbers
91 of 91 codes
IC2449IC2451IC2452IC2453IC2459IC2460IC1096IC1142IC1202IC1203IC1224IC1231IC1238IC1284IC1285IC1390IC1545IC1577IC1665IC1708IC1741IC1852IC1853IC2029IC2071IC2154IC2277IC2278IC2314IC2315IC2368IC2369IC2370IC2442IC2443IC2444IC2461IC2471IC2476IC2477IC2478IC2479IC2575IC2989IC3127IC3128IC3129IC3130IC3166IC3167IC3213IC3223IC3306IC3307IC3308IC3309IC3342IC3398IC3475IC3656
- Amount recalled
- 91 units
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
Stop using this product now
A retrospective review identified that there are AIC units requiring specific hardware updates to address potential safety concerns. These hardware updates have been implemented through Abiomed s servicing process; therefore, AICs that have not received service are pending these updates. Issue 1: The proximity of the internal Video Graphics Array cable to the Digital Signal Processor chipset on the Impellatronic printed circuit assembly could potentially result in Electrostatic Discharge coupling into the Digital Signal Processor which may interrupt motor controls. Issue 2: There is a potential for the Compact Flash Memory Card dislodgement due to external applied forces, which could result in AIC startup failures and data logging issues. Issue 3: Improper routing of the fan wire within the AIC could lead to fan wire damage, which may result in console boot-up failure. Issue 4: Potential capacitor related issues on the Power Battery Manager, including the potential for the capacitors to cause pump stop, purge stop, and/or single fan fuse failures.
Using this product could cause serious injury, illness or death — stop using it now.
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