Lemaitre Vascular, Inc.

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Top device categories

• Catheter, EmbolectomyDXE709
• Catheter, Intravascular Occluding, TemporaryMJN457
• ValvulotomeMGZ109
• Tissue Graft Of 6mm And GreaterLXA92
• Stripper, Vein, ExternalDWQ87
• Mesh, SurgicalFTM47
• Prosthesis, Vascular Graft, Of 6mm And Greater DiameterDSY38
• Graft, Vascular, Synthetic/Biologic CompositeMAL27
• Clip, ImplantableFZP20
• Intracardiac Patch Or Pledget, Biologically DerivedPSQ12

Recent recalls

• 2026-03-19Open, ClassifiedLabeling Change Control

  Artegraft Vascular Graft; REF#: AG740;

  Labeling mix-up resulting in the incorrect lot outer packaging of product.

• 2025-10-23Open, ClassifiedPackaging change control

  Artegraft Collagen Vascular Graft; REF: AG1015;

  The device was incorrectly packed in the wrong size labeled outer packaging.

• 2025-10-08Open, ClassifiedProcess control

  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.

  Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.

• 2025-10-02Open, ClassifiedNonconforming Material/Component

  Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG 715, (7) AG 730, (8) AG 735, (9) AG 740, (10) AG 745, (11) AG 750, (12) AG 830, (13) AG 840, (14) AG 1015, (15) AG 1030;

  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.

• 2025-05-12Open, ClassifiedPackaging process control

  TufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651-38, 1651-44, 1651-48, 1651-58, 1651-64, 1651-68, 1651-78, 1651-84, 1651-88, E1651-34, E1651-38, E1651-44, E1651-48, E1651-64, E1651-68, E1651-78, E1651-84, E1651-88, 1651-44J, 1651-48J, 1651-84J, 1651-88J.

  During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).

• 2025-05-12Open, ClassifiedPackaging process control

  Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56

  During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).

• 2025-05-12Open, ClassifiedPackaging process control

  Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09.

  During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).

• 2024-05-15Open, ClassifiedUnder Investigation by firm

  Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies.

  The guide tip can become damaged and result in the tip detaching.

• 2023-08-28Open, ClassifiedNonconforming Material/Component

  The Chevalier Valvulotome is a device used to disrupt the valves of veins which are to be used as grafts in the in situ or non-reversed bypass procedure. The Chevalier Valvulotome consists of a 70 cm stainless steel shaft with two tips: 1) the cutting tip is shaped like an inverted tulip with four teeth at its base. This tip is designed to cut the vein valve cusps. 2) the other tip is atraumatic and used to test the patency and the course of the vein before the valvulotomy. The Chevalier Valvulotome is available in three tip diameters: 2.5 mm (Catalog # 40025); 3.0 mm (Catalog # 40030); and 3.5 mm (Catalog # 40035)

  Burrs (molding flash) on the cutter may tear the harvested vien

• 2022-11-11Open, ClassifiedProcess design

  TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion. It is inserted using a guidewire or introducer. The devices affected by this recall are 3F and 4F..

  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.