Artegraft Collagen Vascular Graft recalled over labeling errors

Recall date

August 25, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

LeMaitre Vascular, Inc. recalls Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, AG845M. The Artegraft is…

Recall number

Z-0072-2026

FDA classification

Class II

Brand / firm

LeMaitre Vascular, Inc.

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.