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LeMaitre Vascular Recalls
70 recalls on record · April 10, 2013 to March 25, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
March 25, 2026Medical DevicesFDA
LeMaitre Vascular, Inc. recalls Artegraft Vascular Graft; REF#: AG740;
Hazard: Labeling mix-up resulting in the incorrect lot outer packaging of product.
October 29, 2025Medical DevicesFDA
LeMaitre Vascular, Inc. recalls Artegraft¿ Collagen Vascular Graft; REF: AG1015;
Hazard: The device was incorrectly packed in the wrong size labeled outer packaging.
October 15, 2025Medical DevicesFDA
LeMaitre Vascular, Inc. recalls Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, AG845M. The Artegr
Hazard: Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.
October 8, 2025Medical DevicesFDA
LeMaitre Vascular, Inc. recalls Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG 71
Hazard: 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 reviewed and approved by the appropriate regulatory authority.
May 21, 2025Medical DevicesFDA
LeMaitre Vascular, Inc. recalls Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09.
Hazard: During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
May 21, 2025Medical DevicesFDA
LeMaitre Vascular, Inc. recalls Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56
Hazard: During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
May 21, 2025Medical DevicesFDA
LeMaitre Vascular, Inc. recalls TufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651-38, 1651-44, 1651-48, 1651-58, 1651-64, 1
Hazard: During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
May 22, 2024Medical DevicesFDA
LeMaitre Vascular, Inc. recalls Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies.
Hazard: The guide tip can become damaged and result in the tip detaching.
September 6, 2023Medical DevicesFDA
LeMaitre Vascular, Inc. recalls The Chevalier Valvulotome is a device used to disrupt the valves of veins which are to be used as grafts in the in situ
Hazard: Burrs (molding flash) on the cutter may tear the harvested vien
November 23, 2022Medical DevicesFDA
LeMaitre Vascular, Inc. recalls TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion. It is inserte
Hazard: Three lots tied by two trainees were released without performing the required pull test. If tied with inadequate strength, the proximal ligature could slip toward the tip of the catheter and block the inflation hole, leading to the risk of the tip breaking off, and potentially becoming lost in the blood vessel.
May 12, 2021Medical DevicesFDA
LeMaitre Vascular, Inc. recalls LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Product Usage: intended to be used to perfuse
Hazard: The firm received a complaint regarding particulate found in the packaging foam that could contaminate the sterile field.
April 8, 2020Medical DevicesFDA
LeMaitre Vascular, Inc. recalls LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88, e1651-88. The LeMaitre Ov
Hazard: There has been an increased trend in reports of catheters failing to deflate during use, which may ultimately lead to tip separation.
September 11, 2019Medical DevicesFDA
LeMaitre Vascular, Inc. recalls The LeMaitre Aortic Occlusion Catheter is a single lumen catheter with a latex balloon, it is offered in two balloon siz
Hazard: incorrect device size being listed on the impacted device packaging
November 28, 2018Medical DevicesFDA
LeMaitre Vascular, Inc. recalls LeMaitre Vascular Pruitt F3¿-S Polyurethane Outlying Carotid Shunt, Sterile Model # 2014-10
Hazard: Pouches from this lot are not sealed compromising the sterility
September 19, 2018Medical DevicesFDA
LeMaitre Vascular, Inc. recalls AnastoClip GC Closure System, REF# 4007-08 a closure system designed to penetrate the outer layers of tissue during the
Hazard: The wrong instructions for use (IFU) were supplied with the AnastoClip GC closure system. The IFU provided lists some indications which are not cleared by the FDA for devices distributed in the United States: 1) closure of arteriotomies and veinotomies, 2) attachment of synthetic vascular prostheses, and 3) approximation of dural tissue.
March 22, 2017Medical DevicesFDA
LeMaitre Vascular, Inc. recalls LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter with Introducer (paper IFU) REF# 2401-53
Hazard: The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
March 22, 2017Medical DevicesFDA
LeMaitre Vascular, Inc. recalls LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-53
Hazard: The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
March 22, 2017Medical DevicesFDA
LeMaitre Vascular, Inc. recalls LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (paper IFU) REF# 2401-52
Hazard: The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
March 22, 2017Medical DevicesFDA
LeMaitre Vascular, Inc. recalls LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-52
Hazard: The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
March 22, 2017Medical DevicesFDA
LeMaitre Vascular, Inc. recalls LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (paper IFU) REF# 2401-51
Hazard: The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
March 22, 2017Medical DevicesFDA
LeMaitre Vascular, Inc. recalls LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-51
Hazard: The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
March 22, 2017Medical DevicesFDA
LeMaitre Vascular, Inc. recalls LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter (paper IFU) REF# 2401-50
Hazard: The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
March 22, 2017Medical DevicesFDA
LeMaitre Vascular, Inc. recalls LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter (eIFU) REF# e2401-50
Hazard: The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
March 22, 2017Medical DevicesFDA
LeMaitre Vascular, Inc. recalls LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (eIFU) REF # e2400-53
Hazard: The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
March 22, 2017Medical DevicesFDA
LeMaitre Vascular, Inc. recalls LeMaitre Vascular Reddick Cholangiogram Catheter with introducer(eIFU) REF # e2400-52
Hazard: The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
March 22, 2017Medical DevicesFDA
LeMaitre Vascular, Inc. recalls LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter (eIFU) REF# e2400-51
Hazard: The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
March 22, 2017Medical DevicesFDA
LeMaitre Vascular, Inc. recalls LeMaitre Vascular Reddick Cholangiogram Catheter (eIFU) REF# e2400-50
Hazard: The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
August 24, 2016Medical DevicesFDA
LeMaitre Vascular, Inc. recalls 1.5 mm HYDRO LeMaitre Valvulotome, 40 cm. Sterile REF # 1010-00 Product Usage: The HYDRO LeMaitre Valvulotome is in
Hazard: Wire which deploys the loop may be come detached at the handle causing the device to be inoperable
August 24, 2016Medical DevicesFDA
LeMaitre Vascular, Inc. recalls 1.5 mm HYDRO LeMaitre Valvulotome without LeMills, 98 cm. Sterile REF# 1009-00J Product Usage: The HYDRO LeMaitre V
Hazard: Wire which deploys the loop may be come detached at the handle causing the device to be inoperable
August 24, 2016Medical DevicesFDA
LeMaitre Vascular, Inc. recalls 1.5 mm HYDRO LeMaitre Valvulotome, 98 cm, Sterile REF # 1009-00 Product Usage: The HYDRO LeMaitre Valvulotome is i
Hazard: Wire which deploys the loop may be come detached at the handle causing the device to be inoperable