Thoratec HeartMate 3 Coring Tool — Class II medical device recall Z-1203-2019
Terminated recall by Thoratec Corp., reported 2019-05-01, distributed nationwide. Small black plastic particle was observed in the left ventricle during implant procedure.
| Recall number | Z-1203-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Thoratec Corp., Pleasanton, CA, United States |
| Recall initiated | 2019-03-01 |
| Classified | 2019-04-19 |
| Reported by FDA | 2019-05-01 |
| Terminated | 2022-08-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CA, CH, DE, EE, ES, FR, GB, GR, IN, IT, KW, LT, NL, PL, SA, SG, TR |
| Quantity | 650 |
| Lot numbers | 193495, 193496, 193497, 193498, 193499, 193500, 193501, 193502, 6425740, 6425745, 6425751, 6425756, 6425758, 6425763, 6425766, 6425768, 6425770, 6425773, 6425776, 6449657, 6449662, 6449663, 6449664, 6449675, 6449677, 6449679, 6449680, 6449681, 6449682, 6449684, 6449687, 6449689, 6449691, 6449692, 6512124, 6512126, 6675591, 6675592, 6675594, 6675596 and 38 more |
| Model numbers | 10005872 |
Product
Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an optional accessory of Thoratec HeartMate 3 Left Ventricular Assist System - Product Usage: The HeartMate 3 Coring Tool is intended for use with the HeartMate 3 Left Ventricular Assist System (LVAS). The Coring Tool provides a means to resect a plug of myocardium from the left ventricle, which allows for HeartMate 3 inflow cannula insertion.
Reason for recall
Small black plastic particle was observed in the left ventricle during 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-1203-2019. 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.