HeartMate Mobile Power Unit: REF: 107754 — Class I medical device recall Z-1570-2025
Ongoing recall by Thoratec LLC, reported 2025-04-23, distributed nationwide. Left Ventricular Assist System Mobile Power Unit (MPU) may have electrical component that may cause MPU not to
| Recall number | Z-1570-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Thoratec LLC, Pleasanton, CA, United States |
| Recall initiated | 2025-03-13 |
| Classified | 2025-04-17 |
| Reported by FDA | 2025-04-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BR, CH, CL, CZ, DE, DZ, ES, FI, FR, GB, HK, IL, IT, JP, KR, KW, LB, LT, NL, NO, NZ, OM, PL, PT, RO, RS, SE, SG, TN, TR, TW, ZA |
| Quantity | 1,661 |
| UPC / GTIN / UDI-DI | 05415067038234 |
| Serial numbers | 20226183, 20226184, 20226185, 20226186, 20226187, 20226188, 20226189, 20226190, 20226191, 20226192, 20226193, 20226194, 20226195, 20226196, 20226197, 20226198, 20226199, 20226200, 20226201, 20226202, 20226263, 20226264, 20226265, 20226266, 20226267 and 475 more |
| Model numbers | 107754 |
Product
HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 107758UK, UK; L107758, EU Rental. Used with HeartMate 3 and II Left Ventricular Assist System.
Reason for recall
Left Ventricular Assist System Mobile Power Unit (MPU) may have electrical component that may cause MPU not to turn on, unprompted shut down, or turning off/restarting, may cause system controller to indicate Yellow Wrench or No External Power alarms. If MPU losses power, System Controller can support the pump up to 15 minutes, and if not switched to rechargeable batteries, pump may lose power.
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-1570-2025. 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.