BEUDAMED
    FDA Enforcement Class II Ongoing

    Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D

    Recall: Z-1434-2025 · Reported April 2, 2025

    Enforcement

    Recall Number
    Z-1434-2025
    Event ID
    96292
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Merit Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 2, 2025
    Initiation Date
    January 27, 2025
    Classification Date
    March 24, 2025
    Address
    1600 W Merit Pkwy, N/A, South Jordan, UT, 84095-2416, United States

    Description

    Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D

    Reason

    Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay.

    Code Info

    UDI-DI: 00884450693919. Lot: H3082668. Expiration: 14-Nov-24

    Distribution

    International distribution to the country of Japan.

    Quantity

    40