Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M Recalled by LeMaitre Vascular, Inc. Due to Devices were distributed with incorrect label without CE...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact LeMaitre Vascular, Inc. directly.
Affected Products
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.
Quantity: 10 units
Why Was This Recalled?
Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.
Where Was This Sold?
No US distribution. International distribution to Great Britian and Switzerland.
About LeMaitre Vascular, Inc.
LeMaitre Vascular, Inc. has 69 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report