BEUDAMED
    FDA Recall Open, Classified

    CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared with SynerGraft (SG) Technology.

    Recall: Z-2531-2024 · Initiated May 28, 2024

    Recall

    Recall Number
    Z-2531-2024
    Event Number
    94909
    Firm
    Artivion, Inc
    FEI Number
    3001451326
    Product Code
    OHA
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    May 28, 2024
    Posted
    August 8, 2024
    Address
    1655 Roberts Blvd Nw, Kennesaw, GA, 30144-3632

    Description

    CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared with SynerGraft (SG) Technology.

    Reason

    Grafts were found to have been approved, released, shipped and implanted with an invalid test results.

    Action

    The recalling firm issued letters to their Field Representatives on 5/24/2024 or 5/28/2024 for distribution to the consignees via email or hand delivery. The first date consignees were notified was on 5/28/2024 by their Field Representative. The letter provided the details on the tissue the consignee received, the date it was implanted, and the implanting surgeon. The issue was described and it was pointed out there was no indication the impacted tissues were contaminated and unlikely to pose a health risk to the patient. The letter discussed the testing conducted on each allograft and that the identified allograft was reported to have an invalid Post-Processing Sterility test result or a Pre-Processing Culture test result (depending on the consignee letter), which represents a technical failure in the test, not an indication of a positive result. A response form was enclosed for return to acknowledge receipt of the notification.

    Distribution

    US Nationwide distribution in the states of CA, DC, FL, and NY.

    Quantity

    2 valves