11 results
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46ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88, e1651-88. The LeMaitre Over the Wire Embolectomy Catheter is indicated for use in the removal of emboli and thrombi during embolectomy and/or thrombectomy. It can also be used for catheter placement over a guidewire, vessel occlusion, fluid infusion and/or aspiration.
FDA Recall
Open, Classified
·LeMaitre Vascular, Inc.·Product code DXE·March 23, 2020
Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies.
FDA Recall
Open, Classified
·LeMaitre Vascular, Inc.·Product code DXE·April 17, 2024
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.
FDA Recall
Open, Classified
·LeMaitre Vascular, Inc.·Product code DXE·April 11, 2025
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;
FDA Recall
Open, Classified
·LeMaitre Vascular, Inc.·Product code LXA·September 2, 2025
Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09.
FDA Recall
Open, Classified
·LeMaitre Vascular, Inc.·Product code DQT·April 11, 2025
Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56
FDA Recall
Open, Classified
·LeMaitre Vascular, Inc.·Product code DYG·April 11, 2025
Artegraft Collagen Vascular Graft; REF: AG1015;
FDA Recall
Open, Classified
·LeMaitre Vascular, Inc.·Product code LXA·September 25, 2025
Artegraft Vascular Graft; REF#: AG740;
FDA Recall
Open, Classified
·LeMaitre Vascular, Inc.·Product code LXA·February 10, 2026
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)
FDA Recall
Open, Classified
·LeMaitre Vascular, Inc.·Product code MGZ·July 13, 2023
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..
FDA Recall
Open, Classified
·LeMaitre Vascular, Inc.·Product code DXE·September 30, 2022
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.
FDA Recall
Open, Classified
·LeMaitre Vascular, Inc.·Product code LXA·August 25, 2025