Automated Impella Controller — Class I medical device recall Z-0136-2026
Ongoing recall by Abiomed, Inc., reported 2025-10-29, distributed nationwide. Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures.
| Recall number | Z-0136-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abiomed, Inc., Danvers, MA, United States |
| Recall initiated | 2025-09-16 |
| Classified | 2025-10-17 |
| Reported by FDA | 2025-10-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BR, CA, CH, CZ, DE, ES, FI, FR, GB, GR, HK, HR, IE, IN, IT, JP, KW, LU, MX, NL, PA, PK, PL, SA, SE, SG, TW |
| UPC / GTIN / UDI-DI | 00813502010022, 00813502010428, 00813502010442, 00813502010886, 00813502010930, 00813502010961, 00813502010978, 00813502010985, 00813502011272, 00813502011289, 00813502011296, 00813502011401, 00813502011418, 00813502011425, 00813502011814, 00813502012217, 00813502012484, 00813502012958, 00813502012972, 00813502013030 |
Product
Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect for ECP, Product Code: 1000432. 2. Dbl optical, AIC Impella Connect, Phg US, Product Code: 1000201. 3. Impella Controller, Packaged, AU, Product Code: 0042-0000-AU. 4. Impella Controller, Packaged, CA, Product Code: 0042-0000-CA. 5. Impella Controller, Packaged, EU, Product Code: 0042-0000-EU. 6. Impella Controller, Packaged, IN, Product Code: 0042-0000-IN. 7. Impella Controller, Packaged, JP, Product Code: 0042-0000-JP. 8. Impella Controller, Packaged, UK, Product Code: 0042-0000-UK. 9. Impella Controller, Packaged, US, Product Code: 0042-0000-US. 10. Impella Optical Controller, Packaged, AU, Product Code: 0042-0010-AU. 11. Impella Optical Controller, Packaged, EU, Product Code: 0042-0010-EU. 12. Impella Optical Controller, Packaged, IN, Product Code: 0042-0010-IN. 13. Impella Optical Controller, Packaged, UK, Product Code: 0042-0010-UK. 14. Impella Optical Controller, Packaged, US, Product Code: 0042-0010-US. 15. Optical AIC w/Impella Connect, Pkgd, JP, Product Codes: 0042-0040-JP. 16. Optical AIC w/Impella Connect, Pkgd, JP, Product Codes: 0042-0040-JP-L. 17. Optical AIC w/Impella Connect, Pack'd, CA, Product Code: 0042-0040-CA. 18. Optical AIC w/Impella Connect, Pack'd, EU, Product Code: 0042-0040-EU. 19. Optical, AIC, Impella Connect, Pkgd, AU, Product Code: 0042-0040-AU. 20. Optical, AIC, Impella Connect, Pkgd, UK, Product Code: 0042-0040-UK. 21. Optical, AIC, Impella Connect, Pkgd, US, Product Code: 0042-0040-US.
Reason for recall
Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures.
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-0136-2026. 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.