FDAFDA · Food and drugs·Recall number Z-2531-2024
CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared with SynerGraft (SG) Technology.
Published August 14, 2024 · Recall initiated: May 28, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Grafts were found to have been approved, released, shipped and implanted with an invalid test results.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Artivion, Inc
- Distributor
- US Nationwide distribution in the states of CA, DC, FL, and NY.
- Lot
- Serial #11673489, exp. 27Jan2026; and serial #12657716, exp. 15Aug2028, UDI-DI: 00877234000447
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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