Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, A...
FDA Recall #Z-0072-2026 — Class II — August 25, 2025
Product 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 for Recall
Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.
Recalling Firm
LeMaitre Vascular, Inc. — North Brunswick, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
10 units
Distribution
No US distribution. International distribution to Great Britian and Switzerland.
Code Information
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.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated