# FDA recall Z-2468-2023

> **LeMaitre Vascular, Inc.** · Class II · device recall initiated 2023-07-13.

## 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

- **Recall number:** Z-2468-2023
- **Recalling firm:** LeMaitre Vascular, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-07-13
- **Report date:** 2023-09-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Burlington, MA, United States

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-2468-2023. Retrieved 2026-09-04 from https://api.ai-analytics.org/recall/Z-2468-2023. Source: US FDA. Licensed CC0.

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