Expandable LeMaitre Valvulotome 1000-90Recalls & reported problems

Lemaitre Vascular, Inc. · 1.8mm Expandable LeMaitre Valvulotome, 98 cm · Class 2

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840663100095), received between Jan 2, 2019 and Jan 2, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Open or Close” (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

Difficult to Open or Close1

Patient problems

No Information1

Recent adverse event reports

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

MalfunctionJan 2, 2019Difficult to Open or Close; Difficult to Open or Close
ONE OF THE FOUR CUTTING BLADES OF THE VALVULOTOME DID NOT CLOSE PROPERLY INTO ITS HOUSING. THE MALFUNCTION WAS DETECTED DURING PRE-USE CHECK. SO, THE DEFECTIVE DEVICE WAS REPLACED WITH A NEW VALVULOTOME.
Patient problems: No Information
MAUDE report 8210317 ↗

Device details

UDI-DI	`00840663100095`
Brand	Expandable LeMaitre Valvulotome
Model	1000-90
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	Not 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.

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Eze-Sit Valvulotome 94cm
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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.

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