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

Recalled September 6, 2023 · FDA recall Z-2468-2023 · LeMaitre Vascular

Hazard

Burrs (molding flash) on the cutter may tear the harvested vien · FDA Class II

Units

225 units

Sold at

International distribution to the countries of Belgium, France, Germany, and United Kingdom.

Description

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

Product

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)

Manufacturer(s)

LeMaitre Vascular, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →