Artivion, Inc: Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
- Recalling firm
- Artivion, Inc
- Product
- CryoPatch SynerGraft (SG) Pulmonary Human Cardiac Patch, Model: SGP010
- 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.
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-09-18
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the state of IL.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/895a92dc-b511-4213-b46a-96d759c5b7aa