Artivion SynerGraft cardiac patch recalled over donor age concern
Artivion recalled one CryoPatch SynerGraft pulmonary human cardiac patch (Model SGP010) because it came from a 64-year-old donor, which is older than the program's accepted range of newborn to 60 years. The patch was already implanted, and because long-term data on these patches are limited, early graft dysfunction cannot be ruled out. No injuries have been reported.
From the FDA notice · Read the official notice ↗
What to do
- If you received this patch, talk with your surgeon or cardiologist about follow-up monitoring.
- Hospitals with this patch (serial 12617554, donor 177871) should follow Artivion's recall notice and contact the company for next steps.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- CryoPatch SynerGraft (SG) Pulmonary Human Cardiac Patch, Model: SGP010
- Sold in
- Nationwide
- Made for
- Adults (0 months and older)
Details
- Units affected
- 1
- Illnesses reported
- None reported
- Manufactured in
- 1655 Roberts Blvd Nw, Kennesaw, Georgia, United States
- Classification
- Class II
- Recall number
- Z-0325-2027
In the FDA's words
- Description
- CryoPatch SynerGraft (SG) Pulmonary Human Cardiac Patch, Model: SGP010 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. Serial/Donor Number: 12617554/177871, UDI-DI: 00877234000478, Shipped: 22May2024, Implanted: 05June2024 Distribution: US Nationwide distribution in the state of IL. Affected quantity: 1
- Hazard
- 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.