Reported Sep 23, 2026 · Ongoing · Updated Sep 29, 2026
Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella…
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?
6 of 6 products
| Model / number | Product as published |
|---|---|
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 |
- Lot codes and dates
- 1. Impella Controller, Packaged, CA
- Product Code0042-0000-CA
- UDI-DI00813502010022
- Serial Numbers
IC1324IC1346IC1480IC1481IC1543IC1544IC1572IC1595IC1598IC1664IC1665IC1715IC1769IC1790IC1791IC1911IC1912IC1913IC2032IC2033IC2034IC2035IC2369IC2370IC2686IC2687IC3661IC3662IC3802IC3803IC4944IC4945IC5034IC5050IC5680IC5821IC5824IC6082IC6083IC6633IC6634IC6635IC6636IC7694IC7695IC7716IC8283IC9413IC9414IC9415IC94162. Impella ControllerPackagedEU
- Product Code0042-0000-EU
- UDI-DI00813502011289
- Serial Numbers
979 of 979 codes
IC1347IC1349IC6845IC1285IC1416IC2765IC2766IC3021IC3022IC3718IC3719IC3720IC3776IC5558IC5559IC1578IC1585IC1902IC1903IC1905IC2678IC2679IC2855IC2856IC3053IC3054IC3329IC3671IC3672IC3830IC3831IC4033IC4837IC5086IC5169IC5171IC5560IC5681IC5682IC5683IC6064IC6081IC6149IC6270IC6272IC6437IC6439IC6441IC6443IC6810IC6812IC6813IC6814IC7261IC7262IC7393IC7394IC7576IC7577IC7646
- Product Code0042-0000-IN
- UDI-DI00813502011418
- Serial Numbers
IC6139IC6252IC6253IC6254IC6475IC6476IC6477IC6478IC7079IC7080IC7408IC7409IC7410IC74114. Impella ControllerPackagedJP
- Product Code0042-0000-JP
- UDI-DI00813502010428
- Serial Numbers
303 of 303 codes
IC4732IC5027IC5241IC5243IC5245IC5259IC5260IC5261IC5444IC5445IC5447IC5478IC5505IC5506IC5507IC5510IC5511IC5512IC5515IC5516IC5556IC5563IC5651IC5652IC5653IC5654IC5656IC5657IC5658IC5659IC5660IC5665IC5700IC5727IC5728IC5729IC5731IC5732IC5733IC5734IC5735IC5819IC5820IC5860IC5861IC5862IC5863IC5864IC5865IC5866IC5867IC5868IC5930IC5935IC5936IC5937IC5938IC6046IC6047IC6048
- Product Code0042-0000-UK
- UDI-DI00813502011296
- Serial Numbers
161 of 161 codes
IC1387IC1389IC1519IC1542IC1573IC1792IC1868IC1869IC1909IC2277IC2278IC2493IC2497IC2871IC2872IC3293IC3294IC3295IC3674IC3675IC3784IC3785IC4439IC4440IC4721IC4722IC4739IC4741IC4841IC4842IC5179IC5181IC5219IC5220IC5247IC5553IC5554IC5555IC5831IC5832IC5911IC5912IC5926IC5927IC6286IC6287IC6289IC6290IC6537IC6538IC6540IC6583IC6584IC6585IC6586IC6925IC7056IC7057IC7069IC7070
- Product Code0042-0000-US
- UDI-DI00813502010022
- Serial Numbers
2,496 of 2,496 codes
IC1004IC1006IC1007IC1008IC1014IC1015IC1017IC1019IC1024IC1025IC1026IC1027IC1028IC1029IC1030IC1031IC1032IC1033IC1035IC1036IC1037IC1038IC1039IC1040IC1041IC1042IC1043IC1044IC1046IC1047IC1049IC1050IC1051IC1052IC1053IC1055IC1056IC1058IC1060IC1061IC1062IC1064IC1065IC1066IC1067IC1068IC1069IC1070IC1071IC1072IC1073IC1074IC1075IC1076IC1077IC1078IC1079IC1080IC1081IC1082
- Amount recalled
- 5232 units (3733 US, 1499 OUS) 36 3
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.
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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