Artivion, Inc recalls CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared with Syne…
- Recall date
- May 28, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2531-2024
- FDA classification
- Class II
- Brand / firm
- Artivion, Inc
- Sold / distributed
- US Nationwide distribution in the states of CA, DC, FL, and NY.
Why it was recalled
Grafts were found to have been approved, released, shipped and implanted with an invalid test results.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared with SynerGraft (SG) Technology.
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