Cryolife Inc CryoValve Allograft, Heart valve Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CryoValve Allograft, Heart valve
Brand
Cryolife Inc
Lot Codes / Batch Numbers
Donor #61838, Serial #7691913, Model #SGPV00, Donor #65235, Serial #7915089, Model #SGAV00, Donor #64922, Serial #7883079, Model #SGAV00, Donor #64779, Serial #7883080, Model #SGPV00, Donor #64779 77888910, Model #SGPV00, Donor #64779, Serial #7888909, Model #SGAV00, and Donor #63941, Serial #7894710, Model #SGPV00.
Products Sold
Donor #61838, Serial #7691913, Model #SGPV00; Donor #65235, Serial #7915089, Model #SGAV00, Donor #64922, Serial #7883079, Model #SGAV00; Donor #64779, Serial #7883080, Model #SGPV00; Donor #64779 77888910, Model #SGPV00; Donor #64779, Serial #7888909, Model #SGAV00; and Donor #63941, Serial #7894710, Model #SGPV00.
Cryolife Inc is recalling CryoValve Allograft, Heart valve due to Microorganisms were detected in associated allografts.. 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.
Recommended Action
Per FDA guidance
Implanting physicians were notified via letter on April 30, 2003. They were advised to quarantine and return the allograft if not implanted. A self addressed, stamped postcard was included to affirm receipt of the notice and to provide information of final disposition of the allograft.
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, IL, IN, NM, OH, OK
Page updated: Jan 10, 2026