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FDAAugust 25, 2025device

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

lemaitre vascularlemaitre

UPCs

0031683700001500316837000022003168370000600031683700008400316837000138

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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