Medical Device Recall: 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 repla
LeMaitre Vascular, Inc. · August 25, 2025
Reason for Recall
Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.
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.
Distribution
No US distribution. International distribution to Great Britian and Switzerland.
Quantity Affected
10 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0072-2026
Status: ongoing
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