CryoValve SG Pulmonary Human Heart Valve — Class II medical device recall Z-2531-2024
Ongoing recall by Artivion, Inc, reported 2024-08-14, distributed nationwide. Grafts were found to have been approved, released, shipped and implanted with an invalid test results.
| Recall number | Z-2531-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Artivion, Inc, Kennesaw, GA, United States |
| Recall initiated | 2024-05-28 |
| Classified | 2024-08-08 |
| Reported by FDA | 2024-08-14 |
| Distributed | Nationwide (US) |
| Quantity | 2 valves |
| UPC / GTIN / UDI-DI | 00877234000447 |
| Serial numbers | 11673489, 12657716 |
| Expiration dates | 2026-01-27, 2028-08-15 |
Product
CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared with SynerGraft (SG) Technology.
Reason for recall
Grafts were found to have been approved, released, shipped and implanted with an invalid test results.
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-2531-2024. 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.