Thoratec HeartMate System Monitor — Class I medical device recall Z-1921-2024
Ongoing recall by Thoratec Corp., reported 2024-06-19, distributed nationwide. System monitor screen may display atypical behavior: Overlapping screens/buttons, Frozen screen, Distorted tex
| Recall number | Z-1921-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Thoratec Corp., Pleasanton, CA, United States |
| Recall initiated | 2024-05-08 |
| Classified | 2024-06-07 |
| Reported by FDA | 2024-06-19 |
| 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, IE, IL, IN, IR, IT, JP, KR, KW, KY, LB, LT, LU, MX, MY, NL, NO, OM, PK, PL, PT, QA, RO, RS, SE, SG, SI, TH, TN, TR, TW, ZA |
| Quantity | 4,842 |
| UPC / GTIN / UDI-DI | 00813024010142, 00813024010852 |
| Model numbers | 1286, 1286A, 1286A-CAN, 1286A-US, 1286C, 1286INT, L1286, L1286A, L1286A-US, L1286C, L1286INT, L1386 |
Product
Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US, L1286A-US, 1286C, L1286C, L1386, 1286A-CAN, 1286INT and L1286INT. Left ventricular assist device
Reason for recall
System monitor screen may display atypical behavior: Overlapping screens/buttons, Frozen screen, Distorted text, blanks, or zeroes in place of values, Unresponsive buttons where the user is unable to initiate a command, which may lead to anxiety /inconvenience, hemodynamic compromise, extended surgical time, and Pump Stop command may be selected
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-1921-2024. 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.