BEUDAMED
    FDA Enforcement Class II Ongoing

    CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various cardiovascular catheters into the heart.

    Recall: Z-1677-2022 · Reported September 14, 2022

    Enforcement

    Recall Number
    Z-1677-2022
    Event ID
    90647
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Biosense Webster, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 14, 2022
    Initiation Date
    June 29, 2022
    Classification Date
    September 2, 2022
    Address
    15715 Arrow Hwy, N/A, Irwindale, CA, 91706-2006, United States

    Description

    CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various cardiovascular catheters into the heart.

    Reason

    Outside packaging for a device indicated for introducing cardiovascular catheters into the heart, sustained water damage, which may have affected the sterile barrier of the product inside. Devices with a compromised sterile barrier could be a source for infection.

    Code Info

    UDI-DI: 10846835016253, Lot Number: 00002001

    Distribution

    US Nationwide distribution in the states of AL, GA, AZ, TX, MA, VA, NY, ME, FL, IA, NM, NH, TN, WI, OH, SC, CA, IN.

    Quantity

    98