Cryolife Inc CryoValve, Synegraft Pulmonary Valve & Conduit Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CryoValve, Synegraft Pulmonary Valve & Conduit
Brand
Cryolife Inc
Lot Codes / Batch Numbers
Donor #65019, Serial #7925364, Model #SGPV00
Products Sold
Donor #65019, Serial #7925364, Model #SGPV00
Cryolife Inc is recalling CryoValve, Synegraft Pulmonary Valve & Conduit due to Human tissue for transplantation, which was associated with a donor whose pre-processing culture detected microorganisms, was distributed.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Human tissue for transplantation, which was associated with a donor whose pre-processing culture detected microorganisms, was distributed.
Recommended Action
Per FDA guidance
The physician was notified by letter on 7/10/2003.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, IN
Page updated: Jan 10, 2026