Cryolife Inc CryoValve Allograft, Pulmonary Heart valve & Conduit. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CryoValve Allograft, Pulmonary Heart valve & Conduit.
Brand
Cryolife Inc
Lot Codes / Batch Numbers
Model #PV00, Serial #7916346
Products Sold
Model #PV00, Serial #7916346
Cryolife Inc is recalling CryoValve Allograft, Pulmonary Heart valve & Conduit. due to Microorganisms were detected in associated allografts after initial release of donor.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Microorganisms were detected in associated allografts after initial release of donor.
Recommended Action
Per FDA guidance
The implanting physician was notified via letter on May 5, 2003. Allograft was reported implanted 1/17/2003.
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