Automated Impella Controller — Class I medical device recall Z-2360-2026
Ongoing recall by Abiomed, Inc., reported 2026-06-24, distributed nationwide. Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventr
| Recall number | Z-2360-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abiomed, Inc., Danvers, MA, United States |
| Recall initiated | 2026-05-14 |
| Classified | 2026-06-12 |
| Reported by FDA | 2026-06-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BR, CA, CH, CN, CZ, DE, DK, ES, FI, FR, GB, GR, HK, HR, IE, IL, IN, IT, JP, KR, KW, LU, MX, MY, NL, NO, NZ, PA, PL, RS, SA, SE, SG, SI, TH, TW |
| Quantity | 10,297 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00813502010022, 00813502010428, 00813502010886, 00813502010930, 00813502010961, 00813502010978, 00813502010985, 00813502011272, 00813502011289, 00813502011296, 00813502011401, 00813502011418, 00813502011425, 00813502011814, 00813502012217, 00813502012484, 00813502012958, 00813502012972 |
| Serial numbers | IC10000, IC10001, IC10002, IC10003, IC10004, IC10005, IC10006, IC10007, IC10008, IC10009, IC10010, IC10011, IC10012, IC10013, IC10014, IC10015, IC10016, IC10018, IC10019, IC10020, IC10021, IC10022, IC10025, IC10026, IC10027 and 475 more |
Product
Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 3. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 4. Impella Controller, Packaged, IN; Product Code: 0042-0000-IN. 5. Impella Controller, Packaged, JP; Product Code: 0042-0000-JP. 6. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 7. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 8. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. 9. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 10. Impella Optical Controller, Packaged, IN; Product Code: 0042-0010-IN. 11. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. 12.Impella Optical Controller, Packaged, US, UK; Product Code: 0042-0010-US. 13. Optical AIC w/Impella Connect, Pack'd, CA; Product Code: 0042-0040-CA. 14. Optical AIC w/Impella Connect, Pack'd, EU; Product Code: 0042-0040-EU. 15. Optical AIC w/Impella Connect, Pack'd, JP, EU; Product Code: 0042-0040-JP. 16. Optical, AIC, Impella Connect, Pkgd, AU; Product Code: 0042-0040-AU. 17. Optical, AIC, Impella Connect, Pkgd, UK; Product Code: 0042-0040-UK. 18. Optical, AIC, Impella Connect, Pkgd, US; Product Code: 0042-0040-US.
Reason for recall
Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices.
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-2360-2026. 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.