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LeMaitre Vascular, Inc. recalls Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, AG845M. The Artegr
Recalled October 15, 2025 · FDA recall Z-0072-2026 · LeMaitre Vascular
Hazard
Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card. · FDA Class II
Units
10 units
Sold at
No US distribution. International distribution to Great Britian and Switzerland.
Description
Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.
Product
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.
Manufacturer(s)
LeMaitre Vascular, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →