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.

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

LeMaitre Vascular notified consignees on about 08/25/2025 via letter. Consignees were instructed to identify any affected units in inventory, quarantine those affected units, and arrange for their return. If the product has been implanted, graft explantation/patient intervention is not required. Consignees were also instructed to notify all consignees/customers who should be aware and where affected product has been transferred. Consignees were requested to complete and return the Customer Reply Form. Distributors were requested to indicate that they have quarantine affected units in stock and notified all customers who have received the product.