CryoLife, Inc. CryoValve, Aortic Valve & Conduit Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CryoValve, Aortic Valve & Conduit
Brand
CryoLife, Inc.
Lot Codes / Batch Numbers
Donor number 87732, Serial number 8895131
Products Sold
Donor number 87732, Serial number 8895131
CryoLife, Inc. is recalling CryoValve, Aortic Valve & Conduit due to Tissues taken from a donor whose blood culture was found positive for Serratia marcescens, was distributed.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Tissues taken from a donor whose blood culture was found positive for Serratia marcescens, was distributed.
Recommended Action
Per FDA guidance
Hospitals were notified by letter on 3/24/2008. They were advised not to implanted the tissue and if implanted, they do not recommend explant unless medically necessary. A self addressed, stamped post card was included to confirm receipt of the notification. Serial number 8895391 was reported implanted. Serial number 8895131 was returned to CryoLife for destruction.
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
DE, IN, TN
Page updated: Jan 10, 2026