Brand Name: HeartMate Product Name: HeartMate II¿ LVAS Implant Kit… — Class II medical device recall Z-0507-2026
Ongoing recall by Thoratec LLC, reported 2025-11-26, distributed nationwide. Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup B
| Recall number | Z-0507-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Thoratec LLC, Pleasanton, CA, United States |
| Recall initiated | 2025-10-09 |
| Classified | 2025-11-14 |
| Reported by FDA | 2025-11-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BG, BH, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DZ, EE, EG, ES, FI, FR, GB, GR, IE, IL, IN, IQ, IR, IT, JP, KR, KW, KY, LB, LT, MA, MY, NL, NO, NZ, OM, PE, PL, PT, QA, RO, RS, RU, SA, SE, SG, SI, TH, TN, TR, TW, ZA |
| Quantity | 248 |
| UPC / GTIN / UDI-DI | 00813024011224, 00813024011231 |
| Model numbers | 106015, 106016 |
Product
Brand Name: HeartMate Product Name: HeartMate II¿ LVAS Implant Kit Model/Catalog Number: 106015, HeartMate II¿ LVAS Kit, with Pocket Controller, Sealed, US; 106016, HeartMate II¿ LVAS Kit, with Pocket Controller, Sealed, EU Software Version: N/A Product Description: The HeartMate II LVAS is an axial-flow, rotary ventricular assist system that generates flows up to 10 liters per minute (lpm). One end of the Left Ventricular Assist Device is attached to the apex of the left ventricle; the other end of the device connects to the ascending aorta. The Left Ventricular Assist Device diverts blood from the weakened left ventricle and propels it to the aorta. A small external computer, the System Controller, monitors system operation. A driveline, which passes through the patient s abdomen, connects the implanted pump to the System Controller. The system is powered by a Power Module or Mobile Power Unit (MPU) that is connected to an AC electrical outlet, or by two HeartMate 14 Volt Lithium-Ion batteries. Component: No
Reason for recall
Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
Machine access
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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.