LeMaitre Vascular recalls Artegraft Collagen Vascular Graft models AG630M-AG845M due to missing CE/UKCA marks and patient leaflets. Affected units lack critical safety documentation.
Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.
LeMaitre Vascular is recalling specific models of Artegraft Collagen Vascular Grafts because they were distributed without required CE and UKCA marks, and missing patient leaflets and implant cards. This means the devices may not meet safety standards and could pose risks if used without proper documentation.
The recalled devices lack required CE and UKCA certification marks, which are necessary for medical device safety compliance in the European Union and UK. They also do not include patient leaflets or implant cards that provide critical usage instructions and safety information.
Patients who received the Artegraft Collagen Vascular Grafts with model numbers AG630M, AG636M, AG730M, AG740M, or AG845M are affected. Medical professionals using these grafts for vascular procedures are most at risk.
Check if your Artegraft Collagen Vascular Graft has model numbers AG630M, AG636M, AG730M, AG740M, or AG845M. The device may also have lot numbers listed in the description above.
Look for missing CE or UKCA marks, patient leaflets, and implant cards on the device packaging or product itself.
The Artegraft Collagen Vascular Grafts were distributed without required CE and UKCA certification marks, patient leaflets, and implant cards.
Models AG630M, AG636M, AG730M, AG740M, and AG845M.
No specific stop-use instruction is provided in the recall notice. Affected units should be checked for missing documentation.
We’ve drafted a message you can send LeMaitre Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-0072-2026 — LeMaitre Vascular LeMaitre Vascular Hello, I own a LeMaitre Vascular that is covered by recall Z-0072-2026 from LeMaitre Vascular. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
