FDA Device recall Z-2532-2024
(1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch, SGPH00 Cryopreserved Decellularized Cardiac Tissue Allograft Prepared…
- FDA Device
- Class II
- ongoing
- Published 2024-08-14
On 2024-08-14 the FDA classified a Class II recall of (1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch, SGPH00 Cryopreserved Decellularized Cardiac Tissue Allograft Prepared… 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-2532-2024 |
| 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
(1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch, SGPH00 Cryopreserved Decellularized Cardiac Tissue Allograft Prepared with SynerGraft (SG) Technology; and (2) CryoPatch SG Pulmonary Human Cardiac Branch Patch, SGP020, Cryopreserved Decellularized Cardiac Tissue 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 | (1) SGPH00 - Serial #12071128, exp. 17Nov2027; and serial #11586249, exp. 04May2025; UDI-DI: 00877234000461. (2) SGP02…(1) SGPH00 - Serial #12071128, exp. 17Nov2027; and serial #11586249, exp. 04May2025; UDI-DI: 00877234000461. (2) SGP020 - Serial #12658767, exp. 15Aug2028; UDI-DI: 00877234000485. |
|---|
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-2532-2024%22
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