Recall archive
20 recalls · page 1 of 1
Reported Mar 25, 2026
Artegraft Vascular Graft; REF#: AG740;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.LeMaitre Vascular, Inc.
Matched: Brand · Product · Product details — Labeling mix-up resulting in the incorrect lot outer packaging of product.
FDA (openFDA device enforcement)
Reported Oct 29, 2025
Artegraft¿ Collagen Vascular Graft; REF: AG1015;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.LeMaitre Vascular, Inc.
Matched: Brand · Product · Product details — The device was incorrectly packed in the wrong size labeled outer packaging.
FDA (openFDA device enforcement)
Reported Oct 15, 2025
Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, AG845M. The Artegraft is…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.LeMaitre Vascular, Inc.
Matched: Brand · Product · Product details — Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.
FDA (openFDA device enforcement)
Reported Oct 8, 2025
Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.LeMaitre Vascular, Inc.
Matched: Brand · Product · Product details — The bovine carotid arteries used to produce the impacted grafts from affected lots were sourced using raw material from a supplier that had not been…
FDA (openFDA device enforcement)
Reported May 21, 2025
TufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651-38, 1651-44, 1651-48, 1651-58, 1651-64,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.LeMaitre Vascular, Inc.
Matched: Brand — During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 22, 2024
Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.LeMaitre Vascular, Inc.
Matched: Brand · Product · Product details — The guide tip can become damaged and result in the tip detaching.
FDA (openFDA device enforcement)
Reported Sep 6, 2023
The Chevalier Valvulotome is a device used to disrupt the valves of veins which are to be used as grafts in the in situ…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.LeMaitre Vascular, Inc.
Matched: Brand — Burrs (molding flash) on the cutter may tear the harvested vien
FDA (openFDA device enforcement)
Reported Nov 23, 2022
TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion. It is inserted…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.LeMaitre Vascular, Inc.
Matched: Brand — Three lots tied by two trainees were released without performing the required pull test. If tied with inadequate strength, the proximal ligature…
FDA (openFDA device enforcement)
Reported May 12, 2021
LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Product Usage: intended to be used to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.LeMaitre Vascular, Inc.
Matched: Brand — The firm received a complaint regarding particulate found in the packaging foam that could contaminate the sterile field.
FDA (openFDA device enforcement)
Reported Apr 8, 2020
LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88, e1651-88. The LeMaitre Over…
High riskUsing this product could cause serious injury, illness or death — stop using it now.LeMaitre Vascular, Inc.
Matched: Brand · Product · Product details — There has been an increased trend in reports of catheters failing to deflate during use, which may ultimately lead to tip separation.
FDA (openFDA device enforcement)
Reported Sep 11, 2019
The LeMaitre Aortic Occlusion Catheter is a single lumen catheter with a latex balloon, it is offered in two balloon…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.LeMaitre Vascular, Inc.
Matched: Brand · Product · Product details — incorrect device size being listed on the impacted device packaging
FDA (openFDA device enforcement)
Reported Nov 28, 2018
LeMaitre Vascular Pruitt F3¿-S Polyurethane Outlying Carotid Shunt, Sterile Model # 2014-10
Moderate riskThis product could cause temporary or reversible health problems — stop using it.LeMaitre Vascular, Inc.
Matched: Brand · Product · Product details — Pouches from this lot are not sealed compromising the sterility
FDA (openFDA device enforcement)
Reported Sep 19, 2018
AnastoClip GC Closure System, REF# 4007-08 a closure system designed to penetrate the outer layers of tissue during the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.LeMaitre Vascular, Inc.
Matched: Brand · Reason for recall — The wrong instructions for use (IFU) were supplied with the AnastoClip GC closure system. The IFU provided lists some indications which are not…
FDA (openFDA device enforcement)
Reported Mar 22, 2017
LeMaitre Vascular Reddick Cholangiogram Catheter (eIFU) REF# e2400-50
Moderate riskThis product could cause temporary or reversible health problems — stop using it.LeMaitre Vascular, Inc.
Matched: Brand · Product · Product details — The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
11 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 24, 2016
1.5 mm HYDRO LeMaitre Valvulotome, 98 cm, Sterile REF # 1009-00 Product Usage: The HYDRO LeMaitre Valvulotome is…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.LeMaitre Vascular, Inc.
Matched: Brand · Product · Product details — Wire which deploys the loop may be come detached at the handle causing the device to be inoperable
2 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 3, 2016
Anastoclip AC 8cm 35 Clips (1 Each} Medium REF # 4000-06 The Anastoclip Clip applier consists of a rotating shaft and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.LeMaitre Vascular, Inc.
Matched: Brand — US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog…
6 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 16, 2015
LeMaitre Over-the-Wire Embolectomy Catheter 3F, 40cm, Model 1651-34 and e1651-34. Indicated for the removal of arterial…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.LeMaitre Vascular, Inc.
Matched: Brand · Product · Product details — Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
12 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 25, 2015
LeMaitre Vascular Tumescent Catheter Inversion (TCI) System. The TCI System is intended to provide a system to the…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.LeMaitre Vascular, Inc.
Matched: Brand · Product · Product details — Mislabeled with an incorrect expiration date
FDA (openFDA device enforcement)
Reported Jul 31, 2013
AlboGraft Knitted with Collagen, Bifurcate 14x08 Catalog Number: AMC1408 AlboGraft Vascular Grafts are made of…
High riskUsing this product could cause serious injury, illness or death — stop using it now.LeMaitre Vascular, Inc.
Matched: Brand · Product · Product details — Blood blushing/leaking from the surface of the graft after implantation
16 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 10, 2013
LeMaitre Stent Guide: 1102-00 (100 strips); 1102-50 (50 strips); 1102-20 (20 strips). Intended to be placed on the skin…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.LeMaitre Vascular, Inc.
Matched: Brand · Product · Product details — Devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised.
1 more product in this recall
FDA (openFDA device enforcement)
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