Cryolife Inc CryoValve, Pulmonary Valve & Conduit SG Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CryoValve, Pulmonary Valve & Conduit SG
Brand
Cryolife Inc
Lot Codes / Batch Numbers
Donor #61354, Device #7693941, Model #SGPV00
Products Sold
Donor #61354, Device #7693941, Model #SGPV00
Cryolife Inc is recalling CryoValve, Pulmonary Valve & Conduit SG due to The heart valve procurement exceeded the warm ischemic time criteria.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The heart valve procurement exceeded the warm ischemic time criteria.
Recommended Action
Per FDA guidance
The physician was notified by letter on 8/18/2002. The tissue was reported implanted on 4/08/2003.
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