Reported Oct 29, 2025 · Ongoing
Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes
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) labeled as the following with corresponding Product Codes
21 of 21 products
| Model / number | Product as published |
|---|---|
1000432. | AIC w/Impella Connect for ECP |
1000201. | Dbl optical, AIC Impella Connect, Phg US |
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-UK. | Impella Optical Controller, Packaged, UK |
0042-0010-US. | Impella Optical Controller, Packaged, US |
| — | Optical AIC w/Impella Connect, Pkgd, JP, Product Codes: 0042-0040-JP. |
| — | Optical AIC w/Impella Connect, Pkgd, JP, Product Codes: 0042-0040-JP-L. |
0042-0040-CA. | Optical AIC w/Impella Connect, Pack'd, CA |
0042-0040-EU. | Optical AIC w/Impella Connect, Pack'd, EU |
0042-0040-AU. | Optical, AIC, Impella Connect, Pkgd, AU |
0042-0040-UK. | Optical, AIC, Impella Connect, Pkgd, UK |
- Lot codes and dates
- 1
- Product Code1000432
- GTIN00813502013030; Serial Numbers
- pending correction as of 09/16/2025
IC11239IC11238IC10837IC10497IC10493IC10338IC10362. Serial
- Numbers corrected as of 09/16/2025
IC11404IC11401IC11400IC11399IC10827IC11237IC11236IC11232IC11231IC11230IC11227IC11210IC11182IC11153IC11145IC11143IC10854IC10851IC10849IC10703IC10300IC10786IC10785IC10784IC10762IC10755IC10727IC10689IC10672IC10652IC10651IC10650IC10631IC10588IC10586IC10585IC10584IC10518IC10517IC10496IC10494IC10492IC10483IC10365IC10364IC10353IC10170IC11619IC11616IC11611IC11600. 2
- Product Code1000201
- GTIN00813502010442; Serial Numbers
- pending correction as of 09/16/2025
IC9821IC9820IC9819IC9818IC9817IC9816IC9815IC9814IC9813IC9641IC9637IC9636IC9635IC9633IC9632IC9629. 3
- Product Code0042-0000-AU
- GTIN00813502010886; Serial Numbers
- pending correction as of 09/16/2025
IC7289IC7288IC6531IC5677IC5521IC5238IC5237IC5236. Serial
- Numbers corrected as of 09/16/2025
IC7850IC7849IC7290IC7287IC6530IC6529IC6528IC6527IC6526IC5836IC5752IC5622IC5525IC5524IC5523IC5522IC5341IC5217IC5216. 4
- Product Code0042-0000-CA
- GTIN00813502011272; Serial Numbers
- pending correction as of 09/16/2025
IC4944IC2370IC2369IC2034IC2032IC1715IC1665IC1572IC1544IC1480. Serial
- Numbers corrected as of 09/16/2025
IC9416IC9415IC9414IC9413IC8283IC7716IC7695IC7694IC6636IC6635IC6634IC6633IC6083IC6082IC5824IC5821IC5680IC5034IC5050IC4945IC3803IC3802IC3662IC3661IC2687IC2686IC2035IC2033IC1913IC1912IC1911IC1791IC1790IC1769IC1664IC1598IC1595IC1543IC1481IC1346IC1324. 5
- Product Code0042-0000-EU
- GTIN00813502011289; Serial Numbers
- pending correction as of 09/16/2025
137 of 137 codes
IC7686IC7675IC7584IC7583IC7582IC7581IC7454IC7453IC7452IC7406IC7395IC6880IC6581IC6580IC6578IC6577IC6510IC6489IC6434IC6387IC6386IC6375IC6374IC6373IC6372IC6371IC6370IC6331IC6294IC6293IC6216IC6214IC6165IC6164IC5780IC5779IC5777IC5775IC5687IC5558IC5520IC5492IC5467IC5466IC5465IC5357IC5356IC5251IC5055IC4682IC4681IC4562IC4507IC4358IC4329IC4325IC4257IC4240IC4069IC4068
- Numbers corrected as of 09/16/2025
801 of 801 codes
IC7809IC7748IC7721IC7720IC7719IC7718IC7717IC7693IC7692IC7691IC7690IC7689IC7688IC7687IC7674IC7667IC7666IC7655IC7654IC7653IC7652IC7651IC7650IC7649IC7648IC7647IC7646IC7615IC7614IC7613IC7580IC7579IC7578IC7577IC7576IC7421IC7455IC7407IC7394IC7393IC7392IC7390IC7389IC7388IC7378IC7286IC7265IC7264IC7263IC7262IC7261IC7260IC7259IC7258IC7100IC7099IC7098IC7097IC7096IC7095
- Product Code0042-0000-IN
- GTIN00813502011418; Serial Numbers
- pending correction as of 09/16/2025
IC7411IC7409IC7408IC7080IC7079IC6478IC6477IC6476IC6254IC6253IC6252IC6139. Serial
- Numbers corrected as of 09/16/2025
IC7410IC6475. 7
- Product Code0042-0000-JP
- GTIN00813502010428; Serial Numbers
- pending correction as of 09/16/2025IC5515. Serial
- Numbers corrected as of 09/16/2025
299 of 299 codes
IC8281IC8279IC8278IC8277IC8276IC8084IC8083IC8082IC8081IC8080IC8079IC8078IC8077IC8076IC8054IC8053IC8051IC8050IC8049IC8048IC8047IC8046IC7985IC7984IC7983IC7982IC7981IC7980IC7979IC7978IC7977IC7976IC7935IC7934IC7933IC7929IC7927IC7926IC7905IC7903IC7902IC7901IC7900IC7899IC7898IC7897IC7896IC7853IC7852IC7846IC7815IC7814IC7813IC7812IC7811IC7808IC7806IC7785IC7784IC7783
- Product Code0042-0000-UK
- GTIN00813502011296; Serial Numbers
- pending correction as of 09/16/2025
IC7848IC7847IC7670IC7585IC7443IC6934IC6924IC5999IC5997IC5996IC5995IC5927IC5926IC5557IC5211IC5180IC5220IC5219IC5215IC4857IC4856IC4844IC4843IC4676IC4675IC4525IC4441IC4438IC4331IC4330IC4166IC3785IC3784IC3675IC3674IC3475IC3465IC3464IC3326IC3325IC3312IC3294IC3293IC3174IC2707IC2704IC2496IC2492IC2368IC2367IC2278IC2277IC2023IC1910IC1583IC1582IC1581IC1545. Serial
- Numbers corrected as of 09/16/2025
91 of 91 codes
IC7671IC7669IC7668IC7591IC7447IC7446IC7445IC7444IC7441IC7074IC7073IC7071IC7070IC7069IC7057IC7056IC6925IC6671IC6670IC6669IC6638IC6586IC6585IC6584IC6583IC6543IC6542IC6538IC6537IC6292IC6291IC6290IC6289IC6287IC6286IC6001IC5998IC5915IC5914IC5910IC5833IC5832IC5831IC5830IC5555IC5554IC5553IC5254IC5253IC5247IC5213IC5218IC5214IC5184IC5182IC5181IC5179IC4927IC4926IC4842
- Product Code0042-0000-US
- GTIN00813502010022; Serial Numbers
- pending correction as of 09/16/2025
160 of 160 codes
IC7026IC6835IC6834IC6846IC6825IC6673IC6637IC6632IC6623IC6622IC6597IC6596IC6571IC6559IC6501IC6403IC6360IC6359IC6332IC6330IC6329IC6328IC6322IC6321IC6199IC6042IC5984IC5828IC5750IC5749IC5745IC5721IC5720IC5662IC5661IC5598IC5605IC5549IC5500IC5497IC5201IC5056IC5151IC5120IC4966IC4964IC4895IC4893IC4884IC4832IC4831IC4716IC4715IC4708IC4692IC4641IC4640IC4616IC4452IC4451
- Numbers corrected as of 09/16/2025
2,194 of 2,194 codes
IC7922IC7919IC7032IC7030IC7028IC7027IC6984IC6983IC6982IC6981IC6980IC6979IC6978IC6977IC6976IC6935IC6933IC6932IC6931IC6930IC6929IC6928IC6927IC6926IC6923IC6922IC6921IC6920IC6919IC6918IC6917IC6916IC6915IC6914IC6913IC6912IC6911IC6910IC6909IC6908IC6907IC6906IC6905IC6904IC6901IC6900IC6899IC6898IC6897IC6896IC6895IC6894IC6893IC6889IC6842IC6841IC6840IC6839IC6838IC6837
- Amount recalled
- 9,177 total distributed units (754 pending correction)
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures.
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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