BEUDAMED
    FDA Enforcement Class II Ongoing

    Artegraft¿ Collagen Vascular Graft; REF: AG1015;

    Recall: Z-0289-2026 · Reported October 29, 2025

    Enforcement

    Recall Number
    Z-0289-2026
    Event ID
    97700
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    LeMaitre Vascular, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 29, 2025
    Initiation Date
    September 25, 2025
    Classification Date
    October 23, 2025
    Address
    206 N Center Dr, North Brunswick, NJ, 08902-4246, United States

    Description

    Artegraft¿ Collagen Vascular Graft; REF: AG1015;

    Reason

    The device was incorrectly packed in the wrong size labeled outer packaging.

    Code Info

    REF: AG1015; UDI-DI: 00316837000343; Lot/Serial Number: 23MM581-016;

    Distribution

    US distribution to the state of: AR

    Quantity

    1 unit