Eze-Sit Valvulotome 94cmRecalls & reported problems
Lemaitre Vascular, Inc. · Eze-Sit Valvulotome Overall product length- 94cm Usable/ effective length- 91cm · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840663102297), received between Jun 4, 2021 and Mar 26, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break1
- Connection Problem1
- Mechanical Problem1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 26, 2022Mechanical Problem; Mechanical Problem
THE VALVULOTOME WAS DAMAGED WHEN IT WAS INJECTED. THIS RESULTED IN BLOOD LEAKAGE AND WHEN THE SURGEON ATTEMPTED TO CHANGE THE BLADE HEAD, SHE NEVER SUCCEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13922740 ↗MalfunctionJun 4, 2021Break; Connection Problem
TRIED TO FLUSH THE VALVULOTOME THE CONNECTION WAS BROKEN. FREQUENT PROBLEM. NEW PRODUCT OBTAINED. FDA SAFETY REPORT ID# (B)(4).
Patient problems: Insufficient Information
MAUDE report 11946481 ↗
Other Valvulotome devices
- HYDRO LeMaitre Valvulotome 1009-00Lemaitre Vascular, Inc. · Valvulotome71 reports
- LimFlow Vector VT-US-23Inari Medical, Inc. · Valvulotome1 recall1 report
- Expandable LeMaitre Valvulotome 1000-90Lemaitre Vascular, Inc. · Valvulotome1 report
- Over-the-Wire LeMaitre Valvulotome 1005-00Lemaitre Vascular, Inc. · Valvulotome1 report
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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