Reported Sep 6, 2023 · 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…
LeMaitre Vascular, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: LeMaitre Vascular, Inc. · 32 3rd Ave · Burlington, MA · 01803-4414
Is this the product you have?
3 of 3 products
| Model / number | Product as published |
|---|---|
40025 | 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 ( ) |
40030 | 0 mm ( ) |
40035 | and 3.5 mm ( ) |
- Amount recalled
- 225 units
Why it was recalled
Burrs (molding flash) on the cutter may tear the harvested vien
This product could cause temporary or reversible health problems — stop using it.
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