In the agency's Nov 11, 2026 enforcement report · Ongoing
CryoPatch SynerGraft (SG) Pulmonary Human Cardiac Patch, Model: SGP010
Artivion, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Artivion, Inc · 1655 Roberts Blvd Nw · Kennesaw, GA · 30144-3632
Is this the product you have?
- CryoPatch SynerGraft (SG) Pulmonary Human Cardiac Patch
- ModelSGP010
- Lot codes and dates
- Serial/Donor Number12617554/177871
- UDI-DI00877234000478
- Shipped22May2024
- Implanted05June2024
- Amount recalled
- 1
Where it was sold
- Nationwide
- IL
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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