Cryolife Inc CryoValve Pulmonary Valve and Conduit Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CryoValve Pulmonary Valve and Conduit
Brand
Cryolife Inc
Lot Codes / Batch Numbers
Donor #29640, Serial #6194362, Model #PV00 (Pulmonary Valve)
Products Sold
Donor #29640, Serial #6194362, Model #PV00 (Pulmonary Valve)
Cryolife Inc is recalling CryoValve Pulmonary Valve and Conduit due to As part of this ongoing retrospective review, CryoLife has identified a donor who does not meet current guidelines regarding serodilution of plasma be. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
As part of this ongoing retrospective review, CryoLife has identified a donor who does not meet current guidelines regarding serodilution of plasma because of the amount of transfused/infused fluids administered.
Recommended Action
Per FDA guidance
The consignee was notified by letter on 12/10/2003. CryoLife received confirmation of receipt of the notification from the physician who reported the tissue was implanted on 04/17/1997.
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, TX
Page updated: Jan 10, 2026