BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-2110-2023 · Initiated June 12, 2023

    Recall

    Recall Number
    Z-2110-2023
    Event Number
    92502
    Firm
    Abbott
    FEI Number
    3005334138
    Product Code
    DQY
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    June 12, 2023
    Posted
    July 11, 2023
    Address
    5050 Nathan Ln N, Plymouth, MN, 55442-3209

    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.

    Action

    Abbott issued a MEDICAL DEVICE RECALL notice to its consignees beginning on 06/12/2023. The notice explained the problem with the device, the risk, and requested the return of all units. Should you have questions about this issue, please contact your local Abbott Representative or Abbott Support at 1-800-544-1664 (Option 2) (U.S.), 7:00 a.m. - 7:00 p.m. Central Time, Monday through Friday.

    Distribution

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

    Quantity

    675 units