Reported Aug 6, 2025 · Ongoing
Automated Impella Controller (AIC), used in left heart support blood pump, including the following
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. · 24 Cherry Hill Dr · Danvers, MA · 01923-2575
Is this the product you have?
Automated Impella Controller (AIC), used in left heart support blood pump, including the following
31 of 31 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-EU-L. | Impella Controller, Packaged, EU, Loaner |
0042-0000-IN. | Impella Controller, Packaged, IN |
0042-0000-JP. | Impella Controller, Packaged, JP |
0042-0000-JP-L. | Impella Controller, Japan, Loaner |
0042-0000-UK. | Impella Controller, Packaged, UK |
0042-0000-UK-L. | Impella Controller, UK, Loaner |
0042-0000-US. | Impella Controller, Packaged, US |
0042-0000-US-L. | Impella Controller, Packaged, US, Loaner |
0042-0010-AU. | Impella Optical Controller, Packaged, AU |
0042-0010-EU. | Impella Optical Controller, Packaged, EU |
0042-0010-EU-L. | Impella Optical Controller, EU, Loaner |
0042-0010-IN. | Impella Optical Controller, Packaged, IN |
0042-0010-UK. | Impella Optical Controller, Packaged, UK |
0042-0010-UK-L. | Impella Optical Controller, UK, Loaner |
0042-0010-US. | Impella Optical Controller, Packaged, US |
0042-0010-US-L. | Impella Optical Controller, US, Loaner |
0042-0040-AU. | Optical, AIC, Impella Connect, Packaged, AU |
- Lot codes and dates
- 1
- Product Code0042-0000-AU
- GTIN Number813502010886
- Serial Numbers
IC7849IC7850IC7287IC7288IC7289IC7290IC6526IC6527IC6528IC6529IC6530IC6531IC5622IC5677IC5752IC5836IC5341IC5521IC5522IC5523IC5524IC5525IC5237IC5216IC5217IC5236IC5238. 2
- Product Code0042-0000-CA
- GTIN Number813502011272
- Serial Numbers
IC9416IC9414IC9415IC9413IC8283IC7695IC7716IC7694IC6633IC6634IC6635IC6636IC6082IC6083IC5821IC5824IC5680IC5034IC5050IC4944IC4945IC3802IC3803IC3661IC3662IC2686IC2687IC2369IC2370IC2033IC2035IC2032IC2034IC1911IC1912IC1913IC1790IC1791IC1715IC1769IC1664IC1665IC1595IC1598IC1572IC1543IC1544IC1480IC1481IC1324IC1346. 3
- Product Code0042-0000-EU
- GTIN Number813502011289
- Serial Numbers
985 of 985 codes
IC7809IC7717IC7718IC7719IC7720IC7721IC7748IC7674IC7675IC7686IC7687IC7688IC7689IC7690IC7691IC7692IC7693IC7653IC7654IC7655IC7666IC7667IC7646IC7647IC7648IC7649IC7650IC7651IC7652IC7613IC7614IC7615IC7421IC7576IC7577IC7578IC7579IC7580IC7581IC7582IC7583IC7584IC7455IC7452IC7453IC7454IC7378IC7388IC7389IC7390IC7392IC7393IC7394IC7407IC7395IC7406IC7263IC7264IC7265IC7286
- Product Code0042-0000-EU-L
- GTIN Number813502011289
- Serial Numbers
IC7810IC6065IC4910IC4901IC4891IC4892IC4875IC4876IC4879IC4880IC4881IC4874IC4877IC4878IC4867IC4868IC4869IC4870IC4871IC4872IC4873IC4866IC4855IC4847IC4848IC4849IC4851IC4852IC4853IC4838IC4622IC4625IC4364IC4239IC4032IC3827IC3320IC2986IC2857IC2176IC1906IC1762IC1520IC1521IC1487IC1399IC1303IC1011. 5
- Product Code0042-0000-IN
- GTIN Number813502011418
- Serial Numbers
IC7410IC7411IC7408IC7409IC7079IC7080IC6475IC6476IC6477IC6478IC6139IC6252IC6253IC6254. 6
- Product Code0042-0000-JP
- GTIN Number813502010428
- Serial Numbers
319 of 319 codes
IC8276IC8277IC8278IC8279IC8280IC8281IC8282IC8082IC8083IC8084IC8078IC8079IC8080IC8081IC8047IC8048IC8049IC8050IC8051IC8052IC8053IC8054IC8055IC8076IC8077IC8085IC7981IC7982IC7983IC7984IC7985IC8046IC7933IC7934IC7935IC7976IC7977IC7978IC7979IC7980IC7928IC7929IC7902IC7903IC7904IC7905IC7926IC7927IC7899IC7900IC7901IC7852IC7853IC7854IC7855IC7896IC7897IC7898IC7851IC7812
- Product Code0042-0000-JP-L
- GTIN Number813502010428
- Serial Numbers
IC7448IC7449IC7391IC7432IC7436IC7437IC7438IC7418IC7419IC7428IC7292IC7101IC7086IC7088IC6881IC6884IC6655IC6608IC6609IC6539IC6532IC6493IC6494IC6207IC6209IC5931IC5932IC5934IC5869IC5730IC5508IC5509IC5513IC5514IC5258IC5246IC5029IC5030IC5031IC4730. 8
- Product Code0042-0000-UK
- GTIN Number813502011296
- Serial Numbers
159 of 159 codes
IC7847IC7848IC7668IC7669IC7670IC7671IC7585IC7591IC7444IC7445IC7446IC7447IC7441IC7442IC7443IC7072IC7069IC7070IC7071IC7073IC7074IC7056IC7057IC6934IC6925IC6924IC6638IC6669IC6670IC6671IC6583IC6584IC6585IC6586IC6537IC6538IC6542IC6543IC6540IC6286IC6287IC6289IC6290IC6291IC6292IC6001IC5995IC5996IC5997IC5998IC5999IC5914IC5915IC5911IC5912IC5926IC5927IC5910IC5830IC5831
- Product Code0042-0000-UK-L
- GTIN Number813502011296
- Serial Numbers
IC7776IC7777IC7778IC7592IC3175IC1576IC1493. 10
- Product Code0042-0000-US
- GTIN Number813502010022
- Serial Numbers
2,331 of 2,331 codes
IC7919IC7922IC7028IC7030IC7032IC6976IC6977IC6978IC6979IC6980IC6981IC6982IC6983IC6984IC7026IC7027IC6926IC6927IC6928IC6929IC6930IC6931IC6932IC6933IC6935IC6914IC6915IC6916IC6917IC6918IC6919IC6920IC6921IC6922IC6923IC6904IC6905IC6906IC6907IC6908IC6909IC6910IC6911IC6912IC6913IC6889IC6893IC6894IC6895IC6896IC6897IC6898IC6899IC6900IC6901IC6833IC6836IC6837IC6838IC6839
- Amount recalled
- 11,031 units
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
A potential issue with the Automated Impella Controller (AIC) not detecting an Impella pump when it is connected
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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