Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CryoValve SG Cryopreserved Pulmonary Human Heart Valve Recalled by Artivion, Inc Due to The blood cultures performed as part of the...
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 Cryopreserved Pulmonary Human Heart Valve
Quantity: 1 unit
Why Was This Recalled?
The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus.
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