LeMaitre Vascular, Inc. recalls Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M

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.

• FDA enforcement recordOfficial FDA database entry for Z-0072-2026
• FDA device classification · LXAOfficial FDA classification for this device type
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find LeMaitre Vascular, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.