Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CryoValve SG Pulmonary Human Heart Valve Recalled by Artivion, Inc Due to Grafts were found to have been approved, released,...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Artivion, Inc directly.
Affected Products
CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared with SynerGraft (SG) Technology.
Quantity: 2 valves
Why Was This Recalled?
Grafts were found to have been approved, released, shipped and implanted with an invalid test results.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Artivion, Inc
Artivion, Inc has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report