(1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch,… — Class II medical device recall Z-2532-2024
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-2532-2024 |
|---|---|
| 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) |
| UPC / GTIN / UDI-DI | 00877234000461, 00877234000485 |
| Serial numbers | 11586249, 12071128, 12658767 |
| Expiration dates | 2025-05-04, 2027-11-17, 2028-08-15 |
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 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-2532-2024. 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.