BEUDAMED
    FDA Recall Open, Classified

    Artegraft Collagen Vascular Graft; REF: AG1015;

    Recall: Z-0289-2026 · Initiated September 25, 2025

    Recall

    Recall Number
    Z-0289-2026
    Event Number
    97700
    Firm
    LeMaitre Vascular, Inc.
    FEI Number
    1000121696
    Product Code
    LXA
    Status
    Open, Classified
    Root Cause
    Packaging change control
    Initiated
    September 25, 2025
    Posted
    October 23, 2025
    Address
    206 N Center Dr, North Brunswick, NJ, 08902-4246

    Description

    Artegraft Collagen Vascular Graft; REF: AG1015;

    Reason

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

    Action

    On September 25, 2025, an "URGENT: MEDICAL DEVICE RECALL" letter was sent to the customer. Actions to be taken: Check your inventory against the list of lots in this letter. Immediately quarantine any recalled devices. Complete and return the form provided even if you have no devices in inventory. If the product has been implanted, graft explantation/patient intervention is NOT required. Scan the reply form and send it to [email protected]. When a recalled device has been returned to LeMaitre Vascular, a replacement device will be provided. If you have transferred devices to another facility, please forward a copy of this recall letter to them. If you have any questions, contact Sr. Director, Quality Affairs, via email: [email protected] or at 732-422-8333 Monday through Friday, 8:00AM to 4:30 PM, Eastern Time.

    Distribution

    US distribution to the state of: AR

    Quantity

    1 unit