Class 2 Device Recall CryoValve

• Date Initiated by Firm: September 25, 2003
• Date Posted: October 24, 2003
• Recall Status: Terminated on May 06, 2004
• Recall Number: Z-0065-04
• Recall Event ID: 27390
• Product Classification: Heart-Valve, Allograft - Product Code MIE
• Product: CryoValve, Pulmonary Heart Valve
• Code Information: Donor #68830, Serial #8038836, Model #PV10
• Recalling Firm/ Manufacturer: Cryolife Inc; 1655 Roberts Blvd Nw; Kennesaw GA 30144
• For Additional Information Contact: Sylvie L. Verdon; 770-419-3355
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Other
• Action: 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.
• Quantity in Commerce: 1 unit
• Distribution: The tissue was distributed to one physician in CA.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.