Recall Z-0325-2027 ยท DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Artivion, Inc
CryoPatch SynerGraft (SG) Pulmonary Human Cardiac Patch, Model: SGP010
| Date | Oct 30, 2026 (initiated Sep 18, 2026) |
| Status | Open, Classified |
| Reason | A cryopreserved pulmonary human cardiac patch, taken from a 64-year-old human donor, was outside the cardiac tissue donor age specification of newborn to 60 years. The patch was implanted, and due to limitations of long-term in vivo data, the possibility of premature graft dysfunction cannot be excluded. |
| Root cause | Nonconforming Material/Component |
| Action | On 9/18/2026, the notification was delivered via mail to customer who was advised of the following: Available biomechanical and histological evidence does not indicate an increased risk that would warrant additional patient testing, enhanced clinical monitoring, or other clinical intervention beyond the patient's routine standard of care. Accordingly, prophylactic removal or surgical replacement of the already implanted tissue solely because of the donor-age nonconformance is not clinically warranted. Complete and return the response form via email to fieldassurance@artivion.com Firm reques |
| Quantity | 1 |
| Distribution | US Nationwide distribution in the state of IL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101866 | CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH Cryolife, Inc., Jul 23, 2010 |