Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

The Chevalier Valvulotome is a device used to disrupt the Recalled by LeMaitre Vascular, Inc. Due to Burrs (molding flash) on the cutter may tear...

Date: July 13, 2023
Company: LeMaitre Vascular, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact LeMaitre Vascular, Inc. directly.

Affected Products

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)

Quantity: 225 units

Why Was This Recalled?

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

Where Was This Sold?

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

About LeMaitre Vascular, Inc.

LeMaitre Vascular, Inc. has 69 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report