Valvulotome
Cardiovascular · 21 CFR 870.4885
Recent MDR events
131 adverse event reports on file
- LeMaitre ValvulotomeJun 24, 2026InjuryLemaitre Vascular, Inc.1220948-2026-00160
- LEMAITRE VALVULOTOMEMay 6, 2026InjuryLemaitre Vascular, Inc.1220948-2026-00112
- HYDRO LEMAITRE VALVULOTOMEApr 9, 2026MalfunctionLemaitre Vascular, Inc.24829090
- LEMAITRE VALVULOTOMEMar 30, 2026MalfunctionLemaitre Vascular, Inc.1220948-2026-00056
- LEMAITRE VALVULOTOMEFeb 27, 2026MalfunctionLemaitre Vascular, Inc.1220948-2026-00034
- LEMAITRE VALVULOTOMEDec 18, 2025MalfunctionLemaitre Vascular, Inc.1220948-2025-00221
- LIMFLOW VECTOROct 15, 2025MalfunctionLimflow Inc.3023527320-2025-00004
- LEMAITRE VALVULOTOMESep 26, 2025InjuryLemaitre Vascular, Inc.1220948-2025-00165
- VALVULOTOME VASCULAR OVER THE WIRE EXANDABLE HYDRO LEMAITRE 1.5-6MM 98CM LENGTHSep 3, 2025InjuryLemaitre Vascular, Inc.MW5175582
- EZE-SIT VALVULOTOMEAug 19, 2025MalfunctionLemaitre Vascular, Inc.22838568
Event type breakdown
Recalls
6 recall events for this product code
- LimFlow, Inc.Open, ClassifiedJan 29, 2026
Brand Name: LimFlow Vector
Incorrect expiration date
Z-1218-2026 · View FDA record ↗ - LeMaitre Vascular, Inc.Open, ClassifiedAug 28, 2023
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 Ch
Burrs (molding flash) on the cutter may tear the harvested vien
Z-2468-2023 · View FDA record ↗ - Instrumed International, Inc.TerminatedDec 16, 2014
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
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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.
Z-0536-2015 · View FDA record ↗ - LeMaitre Vascular, Inc.TerminatedUnknown
1.5 mm HYDRO LeMaitre Valvulotome, 98 cm, Sterile
Wire which deploys the loop may be come detached at the handle causing the device to be inoperable
Z-2543-2016 · View FDA record ↗ - LeMaitre Vascular, Inc.TerminatedUnknown
1.5 mm HYDRO LeMaitre Valvulotome without LeMills, 98 cm. Sterile
Wire which deploys the loop may be come detached at the handle causing the device to be inoperable
Z-2544-2016 · View FDA record ↗ - LeMaitre Vascular, Inc.TerminatedUnknown
1.5 mm HYDRO LeMaitre Valvulotome, 40 cm. Sterile
Wire which deploys the loop may be come detached at the handle causing the device to be inoperable
Z-2545-2016 · View FDA record ↗
Registered firms
27 firms currently registered for this product code
Geister Medizintechnik Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Teleflex Medical Llc
Morrisville, NC, US
Lemaitre Vascular, Inc.
BURLINGTON, MA, US
Limflow Inc.
Irvine, CA, US
Aveera Medical
San Clemente, CA, US
Synergy Health Ast, Srl
Alajuela, CR
Lemaitre Vascular Inc.
Billerica, MA, US
Nitinol Devices & Components Costa Rica, S. R. L.
El Coyol Alajuela, CR
Contract Medical International Gmbh
DRESDEN Saxony, DE
Sterigenics U.s., Llc
Queensbury, NY, US
Scanlan International, Inc.
Saint Paul, MN, US
Teleflex Llc (nadc)
Olive Branch, MS, US
510(k) clearances
27 clearances for this product code
- LimFlow, Inc.Mar 18, 2026
K260188 · LimFlow Vector
- Aveera Medical, Inc.Jul 3, 2025
K250105 · Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125)
- LimFlow, Inc.Dec 21, 2022
K221902 · LimFlow Vector
- Lemaitre VascularOct 30, 2019
K190267 · EZE SIT Valvulotome
- LeMaitre Vascular, Inc.Oct 17, 2014
K142660 · Antegrade LeMills Valvulotome
- LeMaitre Vascular, Inc.Apr 10, 2014
K140042 · 1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME
- LeMaitre Vascular, Inc.Nov 5, 2013
K132047 · LEMILLS VALVULOTOME
- LeMaitre Vascular, Inc.Aug 5, 2013
K132190 · EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOME