FDA Device recall Z-1545-2024
CryoValve SG Cryopreserved Pulmonary Human Heart Valve
- FDA Device
- Class II
- ongoing
- Published 2024-04-24
On 2024-04-24 the FDA classified a Class II recall of CryoValve SG Cryopreserved Pulmonary Human Heart Valve by Artivion, citing the blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1545-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-03-06 |
| Published | 2024-04-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Artivion |
| Distribution | US |
Product
CryoValve SG Cryopreserved Pulmonary Human Heart Valve
Reason
The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus.
Identifiers
| code_info | Model/Catalog Number: SGPV00; Serial ID Number: 12578856; UDI-DI Number: 00877234000447; Expiration Date 04/05/2028 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1545-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.