BEUDAMED
    FDA Enforcement Class I Ongoing

    Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac).

    Recall: Z-2110-2023 · Reported July 19, 2023

    Enforcement

    Recall Number
    Z-2110-2023
    Event ID
    92502
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Abbott
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 19, 2023
    Initiation Date
    June 12, 2023
    Classification Date
    July 11, 2023
    Address
    5050 Nathan Ln N, N/A, Plymouth, MN, 55442-3209, United States

    Description

    Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac).

    Reason

    There is an overall reported incidence rate of 0.77% related to observed or potential air embolism during procedures in which the ASDS product was used.

    Code Info

    UDI/DI 05415067036025, Batch Numbers: 8597228, 8598983, 8601676, 8611443, 8619197, 8627877, 8650955, 8663679, 8795668, 8815423, 8824607, 8830530, 8846835

    Distribution

    Worldwide distribution - US Nationwide and the countries of Slovakia, Czech Republic.

    Quantity

    675 units