BEUDAMED
    FDA Enforcement Class II Terminated

    Amplatzer Steerable Delivery Sheath

    Recall: Z-0895-2022 · Reported April 13, 2022

    Enforcement

    Recall Number
    Z-0895-2022
    Event ID
    89714
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Abbott
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 13, 2022
    Initiation Date
    November 9, 2021
    Classification Date
    April 7, 2022
    Termination Date
    August 7, 2024
    Address
    5050 Nathan Ln N, Plymouth, MN, 55442-3209, United States

    Description

    Amplatzer Steerable Delivery Sheath

    Reason

    Instructions for use were updated.

    Code Info

    Model ASDS-14F-075, Batch Numbers: 1) 7963817 2) 7976534 3) 7981029 4) 7990340 5) 8008111 6) 8010056 7) 8025120 8) 8102214 9) 8106240 10) 8234848 11) 8274323 12) 8277741

    Distribution

    OUS distribution only

    Quantity

    529 units