CentriMag Blood Pump — Class II medical device recall Z-1099-2026
Ongoing recall by Thoratec LLC, reported 2026-01-21, distributed nationwide. Acute circulatory support system pump may not fit into the motor and reports received of the pump not being se
| Recall number | Z-1099-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Thoratec LLC, Pleasanton, CA, United States |
| Recall initiated | 2025-10-10 |
| Classified | 2026-01-15 |
| Reported by FDA | 2026-01-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BH, CA, CH, CO, CR, CY, CZ, DE, DK, DZ, EE, EG, ES, FI, FR, GB, HK, IT, JO, KR, KW, KY, LT, MX, MY, NL, OM, PE, PL, PT, QA, RO, RS, SA, SE, SG, SI, TH, TR, TW, ZA |
| Quantity | 8,399 |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 05415067036414, 07640135140603, 07640135140627 |
| Lot numbers | 10007335, 10007336, 10012012, 10012013, 10012014, 10012015, 10012016, 10012020, 10012021, 10012022, 10012023, 10012024, 10012025, 10012026, 10026482, 10026483, 10026484, 10026485, 10026486, 10026487, 10026488, 10026489, 10036179, 10036180, 10036181, 10037990, 10037992, 10037993, 10037995, 10037996, 10046028, 10046029, 10046030, 10046031, 10046032, 10046033, 10058754, 10058755, 10058756, 10061666 and 460 more |
| Serial numbers | 10007335, 10007336, 10012012, 10012013, 10012014, 10012015, 10012016, 10012020, 10012021, 10012022, 10012023, 10012024, 10012025, 10012026, 10026482, 10026483, 10026484, 10026485, 10026486, 10026487, 10026488, 10026489, 10036179, 10036180, 10036181 and 475 more |
| Model numbers | 102953, 104318, 201-20003, 201-51006, 201-51007, 201-90001, 201-90001T, 201-90010, 201-90016, CMAEK00, CMAEK01 |
Product
CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMag RVAD HDE KIT, REF: 104318; CentriMag Pre-connected Pack, REF: CMAEK00; CentriMag VAD KIT, REF: 201-51006, 201-51007, 201-90001 201-90001T; Blood Pump with CentriMag Acute Circulatory Support System for ECMO, REF: CMAEK01. CentriMag Blood Pump is a component to be used with CentriMag Acute Circulatory Support System
Reason for recall
Acute circulatory support system pump may not fit into the motor and reports received of the pump not being securely locked into the motor using the screw-in locking feature. Failure to properly lock the pump into motor my not cause pump not inserted alarm, and could lead to particulate, increased heat, anxiety, inconvenience, delay in hemodynamic/ECMO support, stroke, embolism, death.
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-1099-2026. 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.