BEUDAMED
    FDA Enforcement Class II Terminated

    CryoValve SG Pulmonary Human Heart Valve. The valve is cryopreserved in a tissue culture medium containing cryoprotectants within the innermost pouch of a three-pouch packaging system. The packaging system not only withstands ultracold temperatures, but also allows for aseptic introduction of the valve into the operating environment. Supercooling by liquid nitrogen boost is begun prior to crystallization to minimize ice crystal damage to the valve matrix. Finally, the valve is transferred to a liquid nitrogen freezer for long-term storage at or below 135¿C. CryoValve SG is distributed in two anatomic configurations: pulmonary valve and conduit, and pulmonary valve.

    Recall: Z-0652-2021 · Reported December 30, 2020

    Enforcement

    Recall Number
    Z-0652-2021
    Event ID
    86890
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CryoLife, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    December 30, 2020
    Initiation Date
    November 10, 2020
    Classification Date
    December 21, 2020
    Termination Date
    October 26, 2021
    Address
    1655 Roberts Blvd Nw, N/A, Kennesaw, GA, 30144-3632, United States

    Description

    CryoValve SG Pulmonary Human Heart Valve. The valve is cryopreserved in a tissue culture medium containing cryoprotectants within the innermost pouch of a three-pouch packaging system. The packaging system not only withstands ultracold temperatures, but also allows for aseptic introduction of the valve into the operating environment. Supercooling by liquid nitrogen boost is begun prior to crystallization to minimize ice crystal damage to the valve matrix. Finally, the valve is transferred to a liquid nitrogen freezer for long-term storage at or below 135¿C. CryoValve SG is distributed in two anatomic configurations: pulmonary valve and conduit, and pulmonary valve.

    Reason

    On November 10, 2020, it was discovered that there are post- processing microbial culture test failures for other allografts, processed using a TRIS saline solution lot that was also used in processing allografts subjected to the recall.

    Code Info

    Model/Catalog Number: SGPV00 Serial Numbers: 11685214, 11685554, and 11682491 UDI: 00877234000447

    Distribution

    Distributed nationwide to GA, AZ, TX, MO, and OK.

    Quantity

    3 units