CryoValve SG Cryopreserved Pulmonary Human Heart Valve — Class II medical device recall Z-1545-2024
Ongoing recall by Artivion, Inc, reported 2024-04-24, distributed nationwide. The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus.
| Recall number | Z-1545-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Artivion, Inc, Kennesaw, GA, United States |
| Recall initiated | 2024-03-06 |
| Classified | 2024-04-16 |
| Reported by FDA | 2024-04-24 |
| Distributed | Nationwide (US) |
| Quantity | 1 units |
| Pathogens | staphylococcus |
| UPC / GTIN / UDI-DI | 00877234000447 |
| Serial numbers | 12578856 |
| Model numbers | SGPV00 |
| Expiration dates | 2028-04-05 |
Product
CryoValve SG Cryopreserved Pulmonary Human Heart Valve
Reason for recall
The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus.
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-1545-2024. 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.