BEUDAMED
    FDA Enforcement Class II Ongoing

    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 · Reported October 15, 2025

    Enforcement

    Recall Number
    Z-0072-2026
    Event ID
    97567
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    LeMaitre Vascular, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    October 15, 2025
    Initiation Date
    August 25, 2025
    Classification Date
    October 8, 2025
    Address
    206 N Center Dr, North Brunswick, NJ, 08902-4246, United States

    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.

    Code Info

    Model/Catalog/Part Number, UDI-DI (lot Numbers): 1. AG630M, 00316837000015 (24H361-021, 24H361-022, 24HH359-016). 2. AG636M, 00316837000022 (24H380-009). 3. AG730M, 00316837000060 (24H380-014, 24H380-004). 4. AG740M, 00316837000084 (24H380-003, 24H380-002). 5. AG845M, 00316837000138 (24HH350-017, 24HH359-011). Expiration date: 28 Jul 2027.

    Distribution

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

    Quantity

    10 units