Open, Classified

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 Z-2468-2023 · Posted 2023-08-28

Recalling FirmLeMaitre Vascular, Inc.

Recall StatusOpen, Classified

Product CodeMGZ

Date Initiated2023-07-13

Product Quantity225 units

Reason for Recall

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

Firm Action

LeMaitre issued Field Safety Notice (FSN) Chevalier Valvulotome (FSCA Ref: CAPA 2023-022) on July 13, 2023 to OUS Customers. Letter states reason for recall, health risk and action to take: Please quarantine the affected devices. Then, return the faxback/reply form (at the end of this FSN) to LeMaitre Vascular as soon as possible. Then, LeMaitre will give you instructions on how to return the devices.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.