Device recall
CryoPatch SynerGraft (SG) Pulmonary Human Cardiac Patch, Model: SGP010
- Recall number
- Z-0325-2027
- Event id
- 100012
- Status
- Open, Classified
- FDA classification
- Class II
- Recalling firm
- Artivion, Inc
- Posted
- Oct 30, 2026
- Initiated
- Sep 18, 2026
- Product code
- DXZ
- Device type
- Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
- 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
- Quantity
- 1
- Code info
- Serial/Donor Number: 12617554/177871, UDI-DI: 00877234000478, Shipped: 22May2024, Implanted: 05June2024
- Distribution
- US Nationwide distribution in the state of IL.
- Related 510(k)s
- K101866
- Location
- Kennesaw, GA