Thoratec HeartMate 3 — Class I medical device recall Z-1692-2024
Ongoing recall by Thoratec Corp., reported 2024-05-08, distributed nationwide. Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and th
| Recall number | Z-1692-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Thoratec Corp., Pleasanton, CA, United States |
| Recall initiated | 2024-03-01 |
| Classified | 2024-05-01 |
| Reported by FDA | 2024-05-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BD, 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, KY, LB, LT, MA, MX, MY, NL, NO, NZ, OM, PH, PL, PT, QA, RO, RS, RU, SA, SE, SG, SI, TH, TN, TR, TW, ZA |
| Quantity | 882 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00813024013297 |
| Serial numbers | MLP-021519, MLP-025911, MLP-026628, MLP-026733, MLP-026929, MLP-027005, MLP-027322, MLP-027363, MLP-027387, MLP-027390, MLP-027596, MLP-027675, MLP-027678, MLP-027879, MLP-028290, MLP-028518, MLP-028665, MLP-028754, MLP-028931, MLP-029026, MLP-029108, MLP-029187, MLP-029304, MLP-029321, MLP-029368 and 475 more |
| Model numbers | 106524US |
Product
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
Reason for recall
Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff.
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-1692-2024. 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.