PlainRecalls
FDA Devices Moderate Class II Ongoing

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 Valv

Reported: September 6, 2023 Initiated: July 13, 2023 #Z-2468-2023

Product Description

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

Details

Recalling Firm
LeMaitre Vascular, Inc.
Units Affected
225 units
Distribution
International distribution to the countries of Belgium, France, Germany, and United Kingdom.
Location
Burlington, MA

Frequently Asked Questions

What product was recalled? ▼
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). Recalled by LeMaitre Vascular, Inc.. Units affected: 225 units.
Why was this product recalled? ▼
Burrs (molding flash) on the cutter may tear the harvested vien
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 6, 2023. Severity: Moderate. Recall number: Z-2468-2023.

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