Cryolife Inc CryoValve Pulmonary Valve & Conduct Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CryoValve Pulmonary Valve & Conduct
Brand
Cryolife Inc
Lot Codes / Batch Numbers
Model Number PV00, Serial Number 8041312
Products Sold
Model Number PV00, Serial Number 8041312
Cryolife Inc is recalling CryoValve Pulmonary Valve & Conduct due to CryoLife received information that an allograft associated with the donor had been linked to a complaint of an alleged positive pre-implant culture. . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
CryoLife received information that an allograft associated with the donor had been linked to a complaint of an alleged positive pre-implant culture. Specifically Clostridium baratii was detected on the pre-implant culture performed at the implanting hospital site.
Recommended Action
Per FDA guidance
Consignee was notified by letter on 11/4/2003. The tissue was reported implanted on 10/14/2003. The letter was intended to provide the hospital with a basis to determine if any additional patient surveillance or intervention is necessary. A self addressed, stamped postcard was enclosed to verify receipt of notification.
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
IN, MO
Page updated: Jan 10, 2026