FDA recall, , Moderate risk
Artivion CryoPatch SynerGraft Pulmonary Human Cardiac Patch
The patch was implanted, and due to limitations of long-term in vivo data, the possibility of premature graft dysfunction cannot be excluded.
Summary by Recall Canary from the FDA notice
What happened
Artivion, Inc, of Kennesaw, Georgia, voluntarily began a recall on September 18, 2026, of its CryoPatch SynerGraft (SG) Pulmonary Human Cardiac Patch, Model SGP010. The product was taken from a 64-year-old human donor, which 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.
The FDA added the recall to its Enforcement Report and classified it on October 30, 2026. The distribution was in Illinois.
What to do
The FDA notice gives no instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the model number and UDI-DI listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
CryoPatch SynerGraft (SG) Pulmonary Human Cardiac Patch
- Model
- SGP010
- UDI-DI
- 00877234000478
Recall details
- Posted by FDA
- Recall began
- Status
- Open
- Weekly archive
- Listed the week of Oct 26, 2026
- Sold in
US Nationwide distribution in the state of Illinois.
- Recalled by
- Artivion, IncKennesaw, Georgia
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- FDA event number
- 100012
- Recall number
- Z-0325-2027
- Recall type
- Voluntary: Firm initiated
All recalls from Artivion, Inc
Timeline
FDA's Enforcement Report is its public list of recalls; FDA posts a recall by adding it there.
Artivion began the recall
FDA posted the recall to its Enforcement Report and rated it Class II (moderate risk)
Added to Recall Canary
