PlainRecalls

LeMaitre Vascular, Inc.

Compiled from official public sources by the editorial team.

70 recalls on record · Latest: Mar 25, 2026

LeMaitre Vascular, Inc. Recall Insight

LeMaitre Vascular, Inc. appears on 70 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.069% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Mar 25, 2026, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 50 entries, severity tagging shows 1 critical, 49 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 50 of 50 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (50). The date window on this page runs from Dec 16, 2015 to Mar 25, 2026.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Mar 25, 2026

Artegraft Vascular Graft; REF#: AG740;

FDA Devices Moderate Oct 29, 2025

Artegraft¿ Collagen Vascular Graft; REF: AG1015;

FDA Devices Moderate Oct 15, 2025

Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, AG845M. The Artegraft is intended to serve as a…

FDA Devices Moderate Oct 8, 2025

Artegraft 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…

FDA Devices Moderate May 21, 2025

Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56

FDA Devices Moderate May 21, 2025

TufTex 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, 16…

FDA Devices Moderate May 21, 2025

Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09.

FDA Devices Moderate May 22, 2024

Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies.

FDA Devices Moderate Sep 6, 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 proced…

FDA Devices Moderate Nov 23, 2022

TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion. It is inserted using a guidewire or introd…

FDA Devices Moderate May 12, 2021

LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Product Usage: intended to be used to perfuse contrast medias into the ves…

FDA Devices Critical Apr 8, 2020

LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88, e1651-88. The LeMaitre Over the Wire Embolectomy Cathe…

FDA Devices Moderate Sep 11, 2019

The 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…

FDA Devices Moderate Nov 28, 2018

LeMaitre Vascular Pruitt F3¿-S Polyurethane Outlying Carotid Shunt, Sterile Model # 2014-10

FDA Devices Moderate Sep 19, 2018

AnastoClip GC Closure System, REF# 4007-08 a closure system designed to penetrate the outer layers of tissue during the forming of an anastomosis or …

FDA Devices Moderate Mar 22, 2017

LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter with Introducer (paper IFU) REF# 2401-53

FDA Devices Moderate Mar 22, 2017

LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (paper IFU) REF# 2401-52

FDA Devices Moderate Mar 22, 2017

LeMaitre Vascular Reddick Cholangiogram Catheter with introducer(eIFU) REF # e2400-52

FDA Devices Moderate Mar 22, 2017

LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (eIFU) REF # e2400-53

FDA Devices Moderate Mar 22, 2017

LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter (eIFU) REF# e2401-50

FDA Devices Moderate Mar 22, 2017

LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-52

FDA Devices Moderate Mar 22, 2017

LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-51

FDA Devices Moderate Mar 22, 2017

LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter (paper IFU) REF# 2401-50

FDA Devices Moderate Mar 22, 2017

LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-53

FDA Devices Moderate Mar 22, 2017

LeMaitre Vascular Reddick Cholangiogram Catheter (eIFU) REF# e2400-50

FDA Devices Moderate Mar 22, 2017

LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (paper IFU) REF# 2401-51

FDA Devices Moderate Mar 22, 2017

LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter (eIFU) REF# e2400-51

FDA Devices Moderate Aug 24, 2016

1.5 mm HYDRO LeMaitre Valvulotome without LeMills, 98 cm. Sterile REF# 1009-00J Product Usage: The HYDRO LeMaitre Valvulotome is intended for th…

FDA Devices Moderate Aug 24, 2016

1.5 mm HYDRO LeMaitre Valvulotome, 98 cm, Sterile REF # 1009-00 Product Usage: The HYDRO LeMaitre Valvulotome is intended for the treatment of …

FDA Devices Moderate Aug 24, 2016

1.5 mm HYDRO LeMaitre Valvulotome, 40 cm. Sterile REF # 1010-00 Product Usage: The HYDRO LeMaitre Valvulotome is intended for the treatment of v…

FDA Devices Moderate Aug 3, 2016

AnastoClip AC 8cm 35 Clips (1 Each} Large REF # 4000-07 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge conta…

FDA Devices Moderate Aug 3, 2016

AnastoCiip Universal Clip Remover (6 Pack} REF# 4001-00 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge cont…

FDA Devices Moderate Aug 3, 2016

Anastoclip AC 8cm 35 Clips (1 Each} Medium REF # 4000-06 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge conta…

FDA Devices Moderate Aug 3, 2016

AnastoCiip Universal Clip Remover (6 Pack} REF# e4001-00 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge cont…

FDA Devices Moderate Aug 3, 2016

Anasto AC Closure System and Anasto Universal Clip Remover- Anasto AC 8cm 25 Clips (1 Each} X-Large REF # 4000-08 The Anastoclip Clip applier…

FDA Devices Moderate Aug 3, 2016

AnastoCiip Universal Clip Remover (1Each} REF# e4001-04 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge contai…

FDA Devices Moderate Aug 3, 2016

AnastoCiip Universal Clip Remover (1Each} REF# 4001-04 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge contai…

FDA Devices Moderate Dec 16, 2015

LeMaitre Over-the-Wire Embolectomy Catheter 6F, 40 cm, Model e-1651-64. Indicated for the removal of arterial emboli and thrombi.

FDA Devices Moderate Dec 16, 2015

LeMaitre Over-the-Wire Embolectomy Catheter 3F, 80cm, Model 1651-38. Indicated for the removal of arterial emboli and thrombi.

FDA Devices Moderate Dec 16, 2015

LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 6F, 80 cm, Model 1601-68. Indicated for the removal of arterial emboli and thrombi.

FDA Devices Moderate Dec 16, 2015

LeMaitre Single Lumen Embolectomy Catheter 4F, 80 cm, Model 1601-48 and e1601-48. Indicated for the removal of arterial emboli and thrombi.

FDA Devices Moderate Dec 16, 2015

LeMaitre Over-the-Wire Embolectomy Catheter 4F, 80cm, Model 1651-48 and e1654-48. Indicated for the removal of arterial emboli and thrombi.

FDA Devices Moderate Dec 16, 2015

LeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm, Model 1601-38 and e1601-38. Indicated for the removal of arterial emboli and thrombi.

FDA Devices Moderate Dec 16, 2015

LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 2F, 60 cm, Model e1801-26. Indicated for the removal of arterial emboli and thrombi.

FDA Devices Moderate Dec 16, 2015

LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 80cm, Model 1651-88 and e1654-88. Indicated for the removal of arterial emboli and thrombi.

FDA Devices Moderate Dec 16, 2015

LeMaitre Over-the-Wire Embolectomy Catheter 6F, 80 cm, Model e-1651-68. Indicated for the removal of arterial emboli and thrombi.

FDA Devices Moderate Dec 16, 2015

LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 40 cm, Model e1651-84. Indicated for the removal of arterial emboli and thrombi.

FDA Devices Moderate Dec 16, 2015

LeMaitre Single Lumen Embolectomy Catheter 5F, 80 cm, Model 1601-58 and e1601-58. Indicated for the removal of arterial emboli and thrombi.

FDA Devices Moderate Dec 16, 2015

LeMaitre Over-the-Wire Embolectomy Catheter 7F, 80cm, Model 1654-78 and e1654-78. Indicated for the removal of arterial emboli and thrombi.

FDA Devices Moderate Dec 16, 2015

LeMaitre Over-the-Wire Embolectomy Catheter 3F, 40cm, Model 1651-34 and e1651-34. Indicated for the removal of arterial emboli and thrombi.

Nearby Manufacturers

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Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.