HeartMate 3 Left Ventricular Assist System — Class I medical device recall Z-1301-2024
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-1301-2024 |
|---|---|
| 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 | 22,663 kits |
| UPC / GTIN / UDI-DI | 00813024011675, 00813024011712, 00813024013266, 00813024013297 |
| Model numbers | 105581, 106524INTUS, 106524US, 106524USUS, 7815, MLP-00, MLP-000991, MLP-002000, MLP-002003, MLP-002005, MLP-002015, MLP-002019, MLP-002022, MLP-002023, MLP-002024, MLP-002026, MLP-002027, MLP-002028, MLP-002043, MLP-002050, MLP-002053, MLP-002055, MLP-002058, MLP-002064, MLP-002066 and 475 more |
Product
HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3 Sealed Outflow Graft with Bend Relief, US 3. HeartMate 3 Sealed Outflow Graft with Bend Relief, OUS 4. HeartMate 3 LVAS Implant Kit, IDE 5. HeartMate 3 LVAS Implant Kit, US 6. HeartMate 3 LVAS Implant Kit, OUS HeartMate 3 Left Ventricular Assist System: The HeartMate 3 LVAS is designed to provide therapeutic benefit to those affected with advanced heart failure. The LVAS assumes some or all of the workload of the left ventricle. The LVAS features a Left Ventricular Assist Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus supporting equipment.
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-1301-2024. 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.