Cryolife Inc CryoValve, Pulmonary Heart Valve Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CryoValve, Pulmonary Heart Valve
Brand
Cryolife Inc
Lot Codes / Batch Numbers
Donor #68830, Serial #8038836, Model #PV10
Products Sold
Donor #68830, Serial #8038836, Model #PV10
Cryolife Inc is recalling CryoValve, Pulmonary Heart Valve due to Additional information obtained from the Outside Tissue Procurement Organization indicated that the donor's attending physician stated that the patie. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Additional information obtained from the Outside Tissue Procurement Organization indicated that the donor's attending physician stated that the patient had pneumonia and it possibly might have been a systemic infection.
Recommended Action
Per FDA guidance
The implanting physician was notified by letter on 9/25/2003. The tissue was reported implanted therefore notification was intended to provide the physician with a basis to determine if any additional patient surveillance or intervention is necessary. A self addressed stamped postcard was enclosed to affirm 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
CA, IN
Page updated: Jan 10, 2026