FDA recall Z-2468-2023

LeMaitre Vascular, Inc. · Class II · device

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)

Reason for recall

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

Distribution

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

Key facts

Status
Ongoing
Initiation date
2023-07-13
Report date
2023-09-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Burlington, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2468-2023