Pulmonary Heart Valve Grafts Recalled Due to Invalid Test Results
Artivion is recalling two CryoValve SG heart valve grafts that were approved and implanted with invalid test results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves implanted heart valve grafts with invalid test results. While no injuries or deaths are reported, the product qualifies as a risk-of-harm medical device where testing integrity is critical.
Plain-English summary
Artivion, Inc. is recalling two CryoValve SG Pulmonary Human Heart Valve grafts (model SGPV00) that were approved, released, shipped, and implanted with invalid test results. These are cryopreserved decellularized heart valve allografts prepared with SynerGraft technology used for pulmonary valve replacement.
The two affected devices are: serial number 11673489 with expiration date 27 January 2026, and serial number 12657716 with expiration date 15 August 2028 (UDI-DI: 00877234000447). These products were distributed nationwide in California, District of Columbia, Florida, and New York.
The recalled product
- Product
- CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared with SynerGraft (SG) Technology.
- Manufacturer
- Artivion, Inc
- Hazard
- invalid-test-results
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Serial #11673489
- exp. 27Jan2026
- and serial #12657716
- exp. 15Aug2028
- UDI-DI: 00877234000447
Distribution
Distributed nationwide across the United States.
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