HeartMate II Left Ventricular Assist System — Class I medical device recall Z-1300-2024
Ongoing recall by Thoratec Corp., reported 2024-03-27, distributed nationwide. Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ve
| Recall number | Z-1300-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Thoratec Corp., Pleasanton, CA, United States |
| Recall initiated | 2024-02-19 |
| Classified | 2024-03-21 |
| Reported by FDA | 2024-03-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BR, CA, CH, CL, CO, CR, CY, CZ, DE, DK, EE, EG, ES, FI, FR, GB, GR, HK, HR, IE, IL, IN, IQ, IR, IT, JP, KR, KW, KY, LB, LT, MA, MX, MY, NL, NO, NZ, OM, PH, PK, PL, PT, QA, RO, RS, SA, SE, SG, SI, SK, TH, TR, TW, ZA |
| Quantity | 2,240 kits |
| UPC / GTIN / UDI-DI | 00813024010005, 00813024010616, 00813024010623, 00813024010807, 00813024010821, 00813024011170, 00813024011224, 00813024011231, 00813024011682, 00813024011996 |
| Serial numbers | VAD-0357, VAD-0638, VAD-10113, VAD-10162, VAD-10198, VAD-10418, VAD-10474, VAD-10543, VAD-10634, VAD-10708, VAD-10734, VAD-10749, VAD-10808, VAD-10840, VAD-10953, VAD-10995, VAD-11081, VAD-11099, VAD-11104, VAD-11131, VAD-11134, VAD-11241, VAD-11250, VAD-11251, VAD-11343 and 475 more |
| Model numbers | 102139, 103393, 103693, 103695, 103695-CAN, 104911, 104911JPN, 104912, 106015, 106016, 106515OUS, 107801, 1355 |
Product
HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed Outflow Graft with Bend Relief REF 103393 2. HeartMate II LVAS Implant Kit, US REF 106015 3. HeartMate II LVAS Implant Kit, OUS REF 106016 Update (February 14, 2024) HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II LVAS Implant Kit, OUS REF 102139 2. HeartMate II LVAS Implant Kit, US REF 1355 3. HeartMate II LVAS Implant Kit (with RSOC Controller), US REF 103695 4. HeartMate II LVAS Implant Kit (with RSOC Controller), OUS REF 103693 5. HeartMate II LVAS Implant Kit (with Sealed Graft), US REF 104911 6. HeartMate II LVAS Implant Kit (with Sealed Graft), OUS REF 104912 7. HeartMate II LVAS Implant Kit (Used for pump exchange, No Graft) REF 107801 8. HeartMate II LVAS Implant Kit, (EPC), CANADA REF 103695-CAN 9. HeartMate II LVAS Implant Kit (with Sealed Graft), JAPAN REF 104911JPN 10. HeartMate II LVAS Implant Kit (with Pocket System Controller and Sealed Grafts), for geographies outside of US & EU REF 106515OUS HeartMate II Left Ventricular Assist System: The HeartMate II LVAS is an axial-flow, rotary ventricular assist system. 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.
Reason for recall
Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System.
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-1300-2024. 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.