Reported Jun 24, 2026 · Ongoing
Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the following with…
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), for use with left heart support blood pump. Labeled as the following with corresponding Product Codes
17 of 17 products
| Model / number | Product as published |
|---|---|
0042-0000-AU. | Impella Controller, Packaged, AU |
0042-0000-CA. | Impella Controller, Packaged, CA |
0042-0000-EU. | Impella Controller, Packaged, EU |
0042-0000-IN. | Impella Controller, Packaged, IN |
0042-0000-JP. | Impella Controller, Packaged, JP |
0042-0000-UK. | Impella Controller, Packaged, UK |
0042-0000-US. | Impella Controller, Packaged, US |
0042-0010-AU. | Impella Optical Controller, Packaged, AU |
0042-0010-EU. | Impella Optical Controller, Packaged, EU |
0042-0010-IN. | Impella Optical Controller, Packaged, IN |
0042-0010-US. | Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. 12.Impella Optical Controller, Packaged, US, UK |
0042-0040-CA. | Optical AIC w/Impella Connect, Pack'd, CA |
0042-0040-EU. | Optical AIC w/Impella Connect, Pack'd, EU |
0042-0040-JP. | Optical AIC w/Impella Connect, Pack'd, JP, EU |
0042-0040-AU. | Optical, AIC, Impella Connect, Pkgd, AU |
0042-0040-UK. | Optical, AIC, Impella Connect, Pkgd, UK |
0042-0040-US. | Optical, AIC, Impella Connect, Pkgd, US |
- Lot codes and dates
- All products below with software versions 6.0.1, 6.0.2, 6.0.3, 7.1 and above. 1
- Product Code0042-0000-AU
- GTIN00813502010886
- Serial Numbers
IC5341IC5523IC5677IC6531IC5525IC6529IC5836IC5524IC7849IC7850IC7287IC7288IC7289IC7290IC6527IC6526IC6528IC6530IC5622IC5752IC5521IC5522IC5217IC5216. 2
- Product Code0042-0000-CA
- GTIN00813502011272
- Serial Numbers
IC9415IC9413IC9416IC9414IC8283IC7716IC7695IC7694IC6635IC6636IC6633IC6634IC6082IC6083IC5821IC5824IC5680IC3802IC2035IC1912IC5034IC5050IC4944IC4945IC3803IC3661IC3662IC2686IC2687IC2033IC1913IC1790IC1791IC1911IC1715IC1769IC1664IC1595IC1598IC1543IC1480IC1481IC1324IC1346. 3
- Product Code0042-0000-EU
- GTIN00813502011289
- Serial Numbers
857 of 857 codes
IC7809IC7720IC7721IC7748IC7719IC7718IC7717IC7691IC7692IC7693IC7689IC7690IC7687IC7688IC7675IC7686IC7674IC7667IC7655IC7666IC7647IC7648IC7649IC7650IC7651IC7652IC7646IC7653IC7654IC7613IC7614IC7615IC7580IC7578IC7579IC7576IC7577IC7421IC7455IC7407IC7395IC7406IC7393IC7394IC7388IC7389IC7390IC7392IC7378IC7286IC7265IC7263IC7264IC7261IC7262IC7258IC7259IC7260IC7098IC7099
- Product Code0042-0000-IN
- GTIN00813502011418
- Serial Numbers
IC6475IC6139IC7410IC7411IC7408IC7409IC7079IC7080IC6477IC6478IC6476IC6252IC6253IC6254. 5
- Product Code0042-0000-JP
- GTIN00813502010428
- Serial Numbers
300 of 300 codes
IC7901IC8276IC8277IC8278IC8279IC8281IC8082IC8083IC8084IC8078IC8079IC8080IC8081IC8050IC7929IC7899IC7900IC7808IC7811IC8047IC8048IC8049IC8051IC8053IC8054IC8076IC8077IC7984IC7853IC7981IC7982IC7983IC7985IC8046IC7934IC7905IC7926IC7927IC7933IC7976IC7979IC7935IC7977IC7978IC7980IC7779IC7902IC7903IC7897IC7898IC7852IC7896IC7812IC7813IC7814IC7815IC7846IC7784IC7785IC7806
- Product Code0042-0000-UK
- GTIN00813502011296
- Serial Numbers
131 of 131 codes
IC7668IC7669IC7670IC7591IC7073IC7847IC7848IC7585IC7443IC7441IC7074IC7671IC7070IC7071IC7444IC7445IC7446IC7447IC7069IC7057IC7056IC6925IC6585IC6586IC6583IC6584IC6542IC6543IC6537IC6538IC6638IC6669IC6670IC6671IC6291IC6292IC6286IC6287IC6289IC6290IC5914IC5915IC5926IC5927IC6001IC5995IC5996IC5997IC5998IC5999IC5910IC5833IC5831IC5832IC5554IC5555IC5553IC5247IC5830IC5557
- Product Code0042-0000-US
- GTIN00813502010022
- Serial Numbers
2,634 of 2,634 codes
IC4744IC7919IC7922IC7026IC7028IC7027IC7030IC7032IC6983IC6984IC6982IC6976IC6977IC6978IC6979IC6980IC6981IC6930IC6931IC6932IC6933IC6935IC6926IC6927IC6928IC6929IC6918IC6919IC6920IC6921IC6922IC6923IC6898IC6897IC6916IC6917IC6889IC6893IC6894IC6895IC6901IC6914IC6915IC6908IC6909IC6910IC6911IC6912IC6913IC6896IC6899IC6900IC6904IC6905IC6906IC6907IC6841IC6842IC6840IC6837
- Amount recalled
- 10,297 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
- Nationwide
Why it was recalled
Stop using this product now
Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
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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