BEUDAMED
    FDA Recall Open, Classified

    Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, AG845M. The Artegraft is intended to serve as a substitute conduit for blood where bypass or replacement of occluded or diseased arterial segments is required or to establish a conduit for hemodialysis.

    Recall: Z-0072-2026 · Initiated August 25, 2025

    Recall

    Recall Number
    Z-0072-2026
    Event Number
    97567
    Firm
    LeMaitre Vascular, Inc.
    FEI Number
    1000121696
    Product Code
    LXA
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    August 25, 2025
    Posted
    October 8, 2025
    Address
    206 N Center Dr, North Brunswick, NJ, 08902-4246

    Description

    Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, AG845M. The Artegraft is intended to serve as a substitute conduit for blood where bypass or replacement of occluded or diseased arterial segments is required or to establish a conduit for hemodialysis.

    Reason

    Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.

    Action

    LeMaitre Vascular notified consignees on about 08/25/2025 via letter. Consignees were instructed to identify any affected units in inventory, quarantine those affected units, and arrange for their return. If the product has been implanted, graft explantation/patient intervention is not required. Consignees were also instructed to notify all consignees/customers who should be aware and where affected product has been transferred. Consignees were requested to complete and return the Customer Reply Form. Distributors were requested to indicate that they have quarantine affected units in stock and notified all customers who have received the product.

    Distribution

    No US distribution. International distribution to Great Britian and Switzerland.

    Quantity

    10 units