Valvulotome
FDA adverse event reports and recall history for valvulotome (product code MGZ), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 131
- Deaths
- 0
- Injuries
- 32
- Malfunctions
- 95
Reports per year
Source: FDA adverse event reports by year received, 2006–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2026-01-29Open, ClassifiedProcess control
Brand Name: LimFlow Vector Product Name: LimFlow Vector Model/Catalog Number: VT-US-23
Incorrect expiration date
- 2023-08-28Open, ClassifiedNonconforming Material/Component
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)
Burrs (molding flash) on the cutter may tear the harvested vien
- 2014-12-16TerminatedNo Marketing Application
An external vein stripper is an extravascular device used to remove a section of a vein sold under the Symmetry Surgical, CareFusion, Boss Instruments, Phoenix Instruments, Autobahn Surgical, Echo Instruments, Millennium Surgical, B.B.M. Surgical Instruments, Stealth Surgical, Medline Industries, Medsaver M S I Precision, and Surgical Direct brand names.
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.
- TerminatedProcess control
1.5 mm HYDRO LeMaitre Valvulotome, 98 cm, Sterile REF # 1009-00 Product Usage: The HYDRO LeMaitre Valvulotome is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves
Wire which deploys the loop may be come detached at the handle causing the device to be inoperable
- TerminatedProcess control
1.5 mm HYDRO LeMaitre Valvulotome without LeMills, 98 cm. Sterile REF# 1009-00J Product Usage: The HYDRO LeMaitre Valvulotome is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves
Wire which deploys the loop may be come detached at the handle causing the device to be inoperable
- TerminatedProcess control
1.5 mm HYDRO LeMaitre Valvulotome, 40 cm. Sterile REF # 1010-00 Product Usage: The HYDRO LeMaitre Valvulotome is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves
Wire which deploys the loop may be come detached at the handle causing the device to be inoperable
Monitor valvulotome automatically
DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.