Automated Impella Controller — Class I medical device recall Z-1591-2026
Ongoing recall by Abiomed, Inc., reported 2026-04-08. Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC) could be del
| Recall number | Z-1591-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abiomed, Inc., Danvers, MA, United States |
| Recall initiated | 2026-02-16 |
| Classified | 2026-03-27 |
| Reported by FDA | 2026-04-08 |
| Countries outside the US | AU, CA, DE, FR, KW |
| Quantity | 62 units |
| UPC / GTIN / UDI-DI | 00813502010022, 00813502010961, 00813502010978, 00813502011272, 00813502011289, 00813502011296, 00813502012217, 00813502012958, 00813502012972 |
| Serial numbers | IC10163, IC10306, IC10312, IC10387, IC10408, IC10425, IC1140, IC11440, IC11472, IC11490, IC11544, IC11546, IC11566, IC12008, IC12054, IC12151, IC12604, IC12605, IC12891, IC12892, IC12894, IC12895, IC1677, IC1910, IC2023 and 37 more |
Product
Automated Impella Controller (AIC), labeled as the following with 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. 5. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 6. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. 7. Optical AIC w/Impella Connect, Pack'd, CA; Product Code: 0042-0040-CA. 8. Optical AIC w/Impella Connect, Pack'd, EU; Product Code: 0042-0040-EU. 9. Optical, AIC, Impella Connect, Pkgd, AU; Product Code: 0042-0040-AU.
Reason for recall
Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC) could be delayed when using first generation Impella 5.5 (0550-0008*) pumps.
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-1591-2026. 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.