Z-2468-2023Class II

The Chevalier Valvulotome is a device used to disrupt the valves of veins which are to be used as grafts in...

Name: Z-2468-2023 The Chevalier Valvulotome is a device used to disrupt the valves of veins which are to be used as grafts in...
Creator: LeMaitre Vascular, Inc.
Published: 2023-07-13
License: https://open.fda.gov/license/

LeMaitre Vascular Inc. / initiated 2023-07-13 / Open, Classified / root cause: manufacturing process

FDA source

LeMaitre Vascular, Inc. began a recall of 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... on 2023-07-13. FDA classified it as Class II and gives the reason as "Burrs (molding flash) on the cutter may tear the harvested vien". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2468-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-07-13
Posted: 2023-08-28
Recalling firm: LeMaitre Vascular Inc.
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)
Product code: MGZ Valvulotome
Reason for recall: Burrs (molding flash) on the cutter may tear the harvested vien
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 225 units
Distribution: International distribution to the countries of Belgium, France, Germany, and United Kingdom.
Product codes and lots: (1)Catalog # 40025 UDI-DI: 00840663110469; (2)Catalog # 40030 UDI-DI: 00840663110476; (3) Catalog # 40035 UDI-DI: 00840663110483 Lot Numbers: All lots starting with CHV. Only lots beginning with CHV are being recalled. Older lots (with CL lot prefixes) are not being recalled. REF (Catalog #) LOT Catalog Number: (1)40025 Lot Number: CHV1003, CHV1006, CHV1022 (2) 40030 Lot Number: CHV1002, CHV1004, (3) 40035 Lot Number: CHV1001, CHV1005

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2468-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2468-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-06	2023-08-28

Product code MGZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)