Over-the-Wire LeMaitre Valvulotome 1005-00Recalls & reported problems

Lemaitre Vascular, Inc. · 2.0mm Over-the-Wire LeMaitre Valvulotome, 100 cm · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840663100132), received between Oct 17, 2018 and Oct 17, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

Insufficient Device Problem Information1

Patient problems

Laceration(s)1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryOct 17, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
DURING FEMORAL POSTERIOR TIBIAL IN-SITU BYPASS, THE CUTTING BLADES OF THE VALVULOTOME CUT THE GREAT SAPHENOUS VEIN ABOUT 4-5 CM ABOVE THE DISTAL END. 6.0 PROLENE WAS USED TO SUTURE THE CUT SECTION OF THE VEIN.
Patient problems: Laceration(s)
MAUDE report 7975612 ↗

Device details

UDI-DI	`00840663100132`
Brand	Over-the-Wire LeMaitre Valvulotome
Model	1005-00
Company	Lemaitre Vascular, Inc.
Product code	MGZ · Valvulotome
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Apr 21, 2021

Device type (GMDN): Valvulotome

A hand-held manual surgical instrument designed for cutting an anatomical valve or valves in situ (e.g., to slit a heart valve or to cut the valves within a vein to allow blood flow in the opposite direction). It is typically a flexible, plastic-coated metal shaft with a proximal handle and an extremely sharp cutting edge at the distal tip (e.g., the distal tip may terminate in a blade which is curved at 90 degrees to the shaft, or an assembly of several thin helicoidal blades that are rotated). This is a reusable device.

Other Valvulotome devices

HYDRO LeMaitre Valvulotome 1009-00
Lemaitre Vascular, Inc. · Valvulotome
71 reports
LimFlow Vector VT-US-23
Inari Medical, Inc. · Valvulotome
1 recall1 report
Eze-Sit Valvulotome 94cm
Lemaitre Vascular, Inc. · Valvulotome
2 reports
Expandable LeMaitre Valvulotome 1000-90
Lemaitre Vascular, Inc. · Valvulotome
1 report

All Valvulotome devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page