SynCardia Total Artificial Heart System — Class II medical device recall Z-1022-2023
Ongoing recall by SynCardia Systems LLC, reported 2023-02-08, distributed nationwide. Due to tears reported tears in the cannula due to wear and tear stress.
| Recall number | Z-1022-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SynCardia Systems LLC, Tucson, AZ, United States |
| Recall initiated | 2022-11-02 |
| Classified | 2023-01-27 |
| Reported by FDA | 2023-02-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, CA, CH, DE, ES, FI, FR, GB, GR, HR, IL, IT, KW, LB, LT, PL, RS, RU, SA, SE, SI, TR |
| Quantity | 1,732 systems |
Product
SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000
Reason for recall
Due to tears reported tears in the cannula due to wear and tear stress.
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-1022-2023. 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.