BEUDAMED
    FDA Recall Open, Classified

    Artegraft Vascular Graft; REF#: AG740;

    Recall: Z-1574-2026 · Initiated February 10, 2026

    Recall

    Recall Number
    Z-1574-2026
    Event Number
    98409
    Firm
    LeMaitre Vascular, Inc.
    FEI Number
    1000121696
    Product Code
    LXA
    Status
    Open, Classified
    Root Cause
    Labeling Change Control
    Initiated
    February 10, 2026
    Posted
    March 19, 2026
    Address
    206 N Center Dr, North Brunswick, NJ, 08902-4246

    Description

    Artegraft Vascular Graft; REF#: AG740;

    Reason

    Labeling mix-up resulting in the incorrect lot outer packaging of product.

    Action

    On February 10, 2026 URGENT: MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken: 1. Check your inventory against the list of lots in this letter. Immediately quarantine any recalled devices. 2. Complete the form at the end of this letter. Please note that you must return the form even if you have no devices in inventory. 3. If the product has been implanted, graft explantation/patient intervention is NOT required. 4. Scan the reply form and send it to [email protected]. 5. When a recalled device has been returned to LeMaitre Vascular, a replacement device will be provided. 6. If you have transferred devices to another facility, please forward a copy of this recall letter to them. If you have any questions, contact Monte Nelson; [email protected]; 732-422-8333 Monday through Friday, 8:00 AM to 4:30 PM, Eastern Time, or email [email protected]

    Distribution

    US Nationwide distribution in the state of IL.

    Quantity

    1 unit