Automated Impella Controller — Class I medical device recall Z-2238-2026
Ongoing recall by Abiomed, Inc., reported 2026-06-03, distributed nationwide. Retrospective submission for following issues identified: 1. Alarm failures, power-path faults, electrical-sho
| Recall number | Z-2238-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abiomed, Inc., Danvers, MA, United States |
| Recall initiated | 2011-01-17 |
| Classified | 2026-05-28 |
| Reported by FDA | 2026-06-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, CA, CH, DE, DK, ES, FR, GB, IT, KW, NL, NO, SA |
| Quantity | 625 units |
| UPC / GTIN / UDI-DI | 00813502010022, 00813502011272, 00813502011289, 00813502011296 |
| Serial numbers | IC1001, IC1002, IC1004, IC1006, IC1007, IC1008, IC1014, IC1015, IC1017, IC1019, IC1024, IC1025, IC1026, IC1027, IC1028, IC1029, IC1030, IC1031, IC1032, IC1033, IC1035, IC1036, IC1037, IC1038, IC1039 and 475 more |
Product
Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 4. Impella Controller, Packaged, US; Product Code: 0042-0000-US.
Reason for recall
Retrospective submission for following issues identified: 1. Alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing were identified in certain AIC consoles. 2. There is improper alignment between the purge cassette and the motor drive in the AIC. This can result in a piston block event and lead to the inability to complete priming of the purge system, requiring the user to switch to backup AIC console.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2238-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.