Thoratec HeartMate 3 LVAS Implant Kit — Class II medical device recall Z-2348-2019
Terminated recall by Thoratec Corp., reported 2019-08-28, distributed nationwide. Outflow Graft leaking at the pump connection during the implantation process. If the C-Ring is insufficiently
| Recall number | Z-2348-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Thoratec Corp., Pleasanton, CA, United States |
| Recall initiated | 2019-03-30 |
| Classified | 2019-08-22 |
| Reported by FDA | 2019-08-28 |
| Terminated | 2020-08-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BR, CA, CH, CL, CO, DE, EG, FR, GB, GR, IR, IT, KW, KY, LB, RO, SG, TH |
| Quantity | 7,200 left |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00813024013297 |
| Lot numbers | 50000000, 6613000 |
| Model numbers | 106524/106524US |
Product
Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only, Left Ventricular Assist System
Reason for recall
Outflow Graft leaking at the pump connection during the implantation process. If the C-Ring is insufficiently seated, it renders the device nonfunctional because the Outflow Graft connection will leak during the implant procedure.
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-2348-2019. 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.