Heartmate 3 LVAS Implant Kit — Class II medical device recall Z-2658-2023
Ongoing recall by Thoratec Corp., reported 2023-10-11, distributed nationwide. Inability to start and/or complete the coring procedure due to inadequate sharpness of the Apical Coring Knife
| Recall number | Z-2658-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Thoratec Corp., Pleasanton, CA, United States |
| Recall initiated | 2023-08-07 |
| Classified | 2023-09-29 |
| Reported by FDA | 2023-10-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BG, BR, CA, CH, CL, CO, CZ, DE, DK, EE, EG, ES, FI, FR, GB, GR, HK, IE, IL, IN, IQ, IR, IT, JP, KR, KW, LB, LT, MA, MX, MY, NL, NO, NZ, PL, PT, QA, RO, RS, RU, SA, SE, SG, SI, TH, TN, TR, TW, ZA |
| Quantity | 2,681 |
| UPC / GTIN / UDI-DI | 00813024010227, 00813024011712, 00813024013297 |
| Serial numbers | 106524INT/00813024011712, MLP-034744, MLP-035485, MLP-035714, MLP-036330, MLP-037708, MLP-038104, MLP-038999, MLP-039000, MLP-039999, MLP-040000, MLP-040999, MLP-041000, MLP-041621 |
| Model numbers | 1050, 106524INT, 106524US |
Product
Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & HeartMate II Apical Coring Knife, REF: 1050
Reason for recall
Inability to start and/or complete the coring procedure due to inadequate sharpness of the Apical Coring Knife, provided with Left Ventricular Assist System, could result in an extended procedure or surgical time while the backup coring knife is acquired.
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-2658-2023. 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.