Class 2 Device Recall CryoPatch SynerGraft

• Date Initiated by Firm: September 18, 2026
• Date Posted: October 30, 2026
• Recall Status: Open, Classified
• Recall Number: Z-0325-2027
• Recall Event ID: 100012
• 510(K)Number: K101866
• Product Classification: Patch, pledget and intracardiac, petp, ptfe, polypropylene - Product Code DXZ
• Product: CryoPatch SynerGraft (SG) Pulmonary Human Cardiac Patch, Model: SGP010
• Code Information: Serial/Donor Number: 12617554/177871, UDI-DI: 00877234000478, Shipped: 22May2024, Implanted: 05June2024
• FEI Number: 3001451326
• Recalling Firm/ Manufacturer: Artivion, Inc; 1655 Roberts Blvd Nw; Kennesaw GA 30144-3632
• For Additional Information Contact: Rochelle Maney; 678-290-4531
• Manufacturer Reason for Recall: A cryopreserved pulmonary human cardiac patch, taken from a 64-year-old human donor, was outside the cardiac tissue donor age specification of newborn to 60 years. The patch was implanted, and due to limitations of long-term in vivo data, the possibility of premature graft dysfunction cannot be excluded.
• FDA Determined Cause: Nonconforming Material/Component
• Action: On 9/18/2026, the notification was delivered via mail to customer who was advised of the following: Available biomechanical and histological evidence does not indicate an increased risk that would warrant additional patient testing, enhanced clinical monitoring, or other clinical intervention beyond the patient's routine standard of care. Accordingly, prophylactic removal or surgical replacement of the already implanted tissue solely because of the donor-age nonconformance is not clinically warranted. Complete and return the response form via email to fieldassurance@artivion.com Firm requests that any observed deficiency, performance concern, or other issue potentially associated with the tissue be reported to them vial email: fieldassurance@artivion.com or phone: +1-770-419-3355
• Quantity in Commerce: 1
• Distribution: US Nationwide distribution in the state of IL.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = DXZ