Recall Register

LeMaitre Vascular, Inc.: FDA recalls

FDA enforcement reports name LeMaitre Vascular, Inc. as the recalling firm in 20 events. The events have 70 product records. The recalls started from 2013 to 2026. All the events are device recalls.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

20 events, newest first.

FDA enforcement events of LeMaitre Vascular, Inc.
InitiatedProduct (first record)TypeClassRecordsStatus
10 Feb 2026Artegraft Vascular Graft; REF#: AG740;DeviceClass II1Ongoing
25 Sep 2025Artegraft Collagen Vascular Graft; REF: AG1015;DeviceClass II1Ongoing
2 Sep 2025Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG 715, (7) AG 730, (8) AG 735, (9) AG 740, (10) AG 745, (11) AG 750, (12) AG 830, (13) AG 840, (14) AG 1015, (15) AG 1030;DeviceClass II1Ongoing
25 Aug 2025Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, AG845M. The Artegraft is intended to serve as a substitute conduit for blood where bypass or replacement of occluded or diseased arterial segments is required or to establish a conduit for hemodialysis.DeviceClass II1Ongoing
11 Apr 2025TufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651-38, 1651-44, 1651-48, 1651-58, 1651-64, 1651-68, 1651-78, 1651-84, 1651-88, E1651-34, E1651-38, E1651-44, E1651-48, E1651-64, E1651-68, E1651-78, E1651-84, E1651-88, 1651-44J, 1651-48J, 1651-84J, 1651-88J.DeviceClass II3Ongoing
17 Apr 2024Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies.DeviceClass II1Ongoing
13 Jul 2023The 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.…DeviceClass II1Ongoing
30 Sep 2022TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion. It is inserted using a guidewire or introducer. The devices affected by this recall are 3F and 4F..DeviceClass II1Ongoing
6 Apr 2021LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Product Usage: intended to be used to perfuse contrast medias into the vessels for angiographic procedures, Catalog #: 4100-00.DeviceClass II1Terminated
23 Mar 2020LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88, e1651-88. The LeMaitre Over the Wire Embolectomy Catheter is indicated for use in the removal of emboli and thrombi during embolectomy and/or thrombectomy. It can also be used for catheter placement over a guidewire, vessel…DeviceClass I1Ongoing
24 Jul 2019The LeMaitre Aortic Occlusion Catheter is a single lumen catheter with a latex balloon, it is offered in two balloon sizes: 28 mm or 45mm. The single lumen acts as the inflation lumen for the balloon and is indicated by the white stopcock. Other features include a balloon wall thickness designed to reduce the…DeviceClass II1Terminated
1 Oct 2018LeMaitre Vascular Pruitt F3¿-S Polyurethane Outlying Carotid Shunt, Sterile Model # 2014-10DeviceClass II1Terminated
19 Jun 2018AnastoClip GC Closure System, REF# 4007-08 a closure system designed to penetrate the outer layers of tissue during the forming of an anastomosis or closing of a vessel with possible intraluminal penetration.DeviceClass II1Terminated
7 Feb 2017LeMaitre Vascular Reddick Cholangiogram Catheter (eIFU) REF# e2400-50DeviceClass II12Terminated
3 Aug 20161.5 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 valvesDeviceClass II3Terminated
22 Jun 2016Anastoclip AC 8cm 35 Clips (1 Each} Medium REF # 4000-06 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an accessory to the Anastoclip AC Clip Applier.DeviceClass II7Terminated
21 Oct 2015LeMaitre Over-the-Wire Embolectomy Catheter 3F, 40cm, Model 1651-34 and e1651-34. Indicated for the removal of arterial emboli and thrombi.DeviceClass II13Terminated
24 Feb 2015LeMaitre Vascular Tumescent Catheter Inversion (TCI) System. The TCI System is intended to provide a system to the removal of an incompetent greater saphenous vein. Catalog Number: 7210023, lot #61049252DeviceClass III1Terminated
17 Jun 2013AlboGraft Knitted with Collagen, Bifurcate 14x08 Catalog Number: AMC1408 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.DeviceClass I17Terminated
18 Mar 2013LeMaitre Stent Guide: 1102-00 (100 strips); 1102-50 (50 strips); 1102-20 (20 strips). Intended to be placed on the skin to assist during imaging procedures.DeviceClass II2Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

LeMaitre Vascular, Inc.: events for each product type
TypeEvents
Device20
LeMaitre Vascular, Inc.: events in each class
ClassEvents
Class II17
Class I2
Class III1
Share of the events of the firm in Class I
10%
Share of all events on the register in Class I
18%
Events with the status Ongoing
9

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of LeMaitre Vascular, Inc., by the year that the recall started. The largest year is 2025, with 4 events.

Official channels

Cite this page

Recall Register. LeMaitre Vascular, Inc.: FDA recalls. https://recallregister.com/firm/lemaitre-vascular-inc/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
MA, NJ

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of LeMaitre Vascular, Inc. have?
Class II: 17 events. Class I: 2 events. Class III: 1 event. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of LeMaitre Vascular, Inc.?
FDA event 98409, which the firm started on 10 Feb 2026. The first product in the record is: Artegraft Vascular Graft; REF#: AG740;
How many FDA recalls of LeMaitre Vascular, Inc. have the status Ongoing?
9 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.