FDA Device recall Z-2531-2024
CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared with SynerGraft (SG) Technolo…
- FDA Device
- Class II
- ongoing
- Published 2024-08-14
On 2024-08-14 the FDA classified a Class II recall of CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared with SynerGraft (SG) Technolo… by Artivion, citing grafts were found to have been approved, released, shipped and implanted with an invalid test results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2531-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-05-28 |
| Published | 2024-08-14 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Artivion |
| Distribution | US |
Product
CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared with SynerGraft (SG) Technology.
Reason
Grafts were found to have been approved, released, shipped and implanted with an invalid test results.
Identifiers
| code_info | Serial #11673489, exp. 27Jan2026; and serial #12657716, exp. 15Aug2028, UDI-DI: 00877234000447 |
|---|
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-2531-2024%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.