Device recall
Z-2532-2024: (1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch, SGPH00…
FDA device recall · Class II · Artivion, Inc
Key facts
| Recall number (Z-number) | Z-2532-2024 |
|---|---|
| Recall event | 94909 |
| 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… |
| Product code | DXZ |
| Recalling firm | Artivion, Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K091626 |
| FEI number | 3001451326 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database