LeMaitre Vascular, Inc.

Complete recall history across all FDA and CPSC categories — 70 total recalls

LeMaitre Vascular, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (70)

FDA medical device enforcement actions by LeMaitre Vascular, Inc.. Showing most recent 50.

Date Product Reason Class
Feb 10, 2026 Artegraft Vascular Graft; REF#: AG740; Labeling mix-up resulting in the incorrect lot outer packaging of product. Class II
Sep 25, 2025 Artegraft¿ Collagen Vascular Graft; REF: AG1015; The device was incorrectly packed in the wrong size labeled outer packaging. Class II
Sep 2, 2025 Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3... The bovine carotid arteries used to produce the impacted grafts from affected... Class II
Aug 25, 2025 Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636... Devices were distributed with incorrect label without CE and UKCA mark, missi... Class II
Apr 11, 2025 Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09. During internal product testing, it was observed that some packages to have i... Class II
Apr 11, 2025 TufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651... During internal product testing, it was observed that some packages to have i... Class II
Apr 11, 2025 Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-... During internal product testing, it was observed that some packages to have i... Class II
Apr 17, 2024 Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular gra... The guide tip can become damaged and result in the tip detaching. Class II
Jul 13, 2023 The Chevalier Valvulotome is a device used to disrupt the valves of veins whi... Burrs (molding flash) on the cutter may tear the harvested vien Class II
Sep 30, 2022 TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon ... Three lots tied by two trainees were released without performing the required... Class II
Apr 6, 2021 LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Pr... The firm received a complaint regarding particulate found in the packaging fo... Class II
Mar 23, 2020 LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e165... There has been an increased trend in reports of catheters failing to deflate ... Class I
Jul 24, 2019 The LeMaitre Aortic Occlusion Catheter is a single lumen catheter with a late... incorrect device size being listed on the impacted device packaging Class II
Oct 1, 2018 LeMaitre Vascular Pruitt F3¿-S Polyurethane Outlying Carotid Shunt, Sterile ... Pouches from this lot are not sealed compromising the sterility Class II
Jun 19, 2018 AnastoClip GC Closure System, REF# 4007-08 a closure system designed to penet... The wrong instructions for use (IFU) were supplied with the AnastoClip GC clo... Class II
Feb 7, 2017 LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter (eIFU) REF# e2400-51 The Contains Latex symbol was not printed onto the box label or the sterile (... Class II
Feb 7, 2017 LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (pap... The Contains Latex symbol was not printed onto the box label or the sterile (... Class II
Feb 7, 2017 LeMaitre Vascular Reddick Cholangiogram Catheter (eIFU) REF# e2400-50 The Contains Latex symbol was not printed onto the box label or the sterile (... Class II
Feb 7, 2017 LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) RE... The Contains Latex symbol was not printed onto the box label or the sterile (... Class II
Feb 7, 2017 LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter (paper IFU... The Contains Latex symbol was not printed onto the box label or the sterile (... Class II
Feb 7, 2017 LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter with Introducer (e... The Contains Latex symbol was not printed onto the box label or the sterile (... Class II
Feb 7, 2017 LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) RE... The Contains Latex symbol was not printed onto the box label or the sterile (... Class II
Feb 7, 2017 LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter (eIFU) REF# e240... The Contains Latex symbol was not printed onto the box label or the sterile (... Class II
Feb 7, 2017 LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (eIF... The Contains Latex symbol was not printed onto the box label or the sterile (... Class II
Feb 7, 2017 LeMaitre Vascular Reddick Cholangiogram Catheter with introducer(eIFU) REF #... The Contains Latex symbol was not printed onto the box label or the sterile (... Class II
Feb 7, 2017 LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (paper IFU... The Contains Latex symbol was not printed onto the box label or the sterile (... Class II
Feb 7, 2017 LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter with Intr... The Contains Latex symbol was not printed onto the box label or the sterile (... Class II
Aug 3, 2016 1.5 mm HYDRO LeMaitre Valvulotome, 40 cm. Sterile REF # 1010-00 Product U... Wire which deploys the loop may be come detached at the handle causing the de... Class II
Aug 3, 2016 1.5 mm HYDRO LeMaitre Valvulotome, 98 cm, Sterile REF # 1009-00 Product ... Wire which deploys the loop may be come detached at the handle causing the de... Class II
Aug 3, 2016 1.5 mm HYDRO LeMaitre Valvulotome without LeMills, 98 cm. Sterile REF# 1009-... Wire which deploys the loop may be come detached at the handle causing the de... Class II
Jun 22, 2016 AnastoCiip Universal Clip Remover (1Each} REF# 4001-04 The Anastoclip Cl... US marketing brochure for the AnastoClip AC Closure System states that the A... Class II
Jun 22, 2016 AnastoCiip Universal Clip Remover (1Each} REF# e4001-04 The Anastoclip Cl... US marketing brochure for the AnastoClip AC Closure System states that the A... Class II
Jun 22, 2016 Anasto AC Closure System and Anasto Universal Clip Remover- Anasto AC 8cm 2... US marketing brochure for the AnastoClip AC Closure System states that the A... Class II
Jun 22, 2016 AnastoCiip Universal Clip Remover (6 Pack} REF# e4001-00 The Anastoclip ... US marketing brochure for the AnastoClip AC Closure System states that the A... Class II
Jun 22, 2016 Anastoclip AC 8cm 35 Clips (1 Each} Medium REF # 4000-06 The Anastoclip C... US marketing brochure for the AnastoClip AC Closure System states that the A... Class II
Jun 22, 2016 AnastoCiip Universal Clip Remover (6 Pack} REF# 4001-00 The Anastoclip ... US marketing brochure for the AnastoClip AC Closure System states that the A... Class II
Jun 22, 2016 AnastoClip AC 8cm 35 Clips (1 Each} Large REF # 4000-07 The Anastoclip C... US marketing brochure for the AnastoClip AC Closure System states that the A... Class II
Oct 21, 2015 LeMaitre Over-the-Wire Embolectomy Catheter 3F, 40cm, Model 1651-34 and e1651... Manufacturing issue that could cause a pinhole in the formed end of the packa... Class II
Oct 21, 2015 LeMaitre Over-the-Wire Embolectomy Catheter 7F, 80cm, Model 1654-78 and e1654... Manufacturing issue that could cause a pinhole in the formed end of the packa... Class II
Oct 21, 2015 LeMaitre Single Lumen Embolectomy Catheter 5F, 80 cm, Model 1601-58 and e1601... Manufacturing issue that could cause a pinhole in the formed end of the packa... Class II
Oct 21, 2015 LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 40 cm, Model e1651-84. ... Manufacturing issue that could cause a pinhole in the formed end of the packa... Class II
Oct 21, 2015 LeMaitre Over-the-Wire Embolectomy Catheter 6F, 80 cm, Model e-1651-68. In... Manufacturing issue that could cause a pinhole in the formed end of the packa... Class II
Oct 21, 2015 LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 80cm, Model 1651-88 and ... Manufacturing issue that could cause a pinhole in the formed end of the packa... Class II
Oct 21, 2015 LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 2F, 60 cm, Model ... Manufacturing issue that could cause a pinhole in the formed end of the packa... Class II
Oct 21, 2015 LeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm, Model 1601-38 and e1601... Manufacturing issue that could cause a pinhole in the formed end of the packa... Class II
Oct 21, 2015 LeMaitre Over-the-Wire Embolectomy Catheter 4F, 80cm, Model 1651-48 and e1654... Manufacturing issue that could cause a pinhole in the formed end of the packa... Class II
Oct 21, 2015 LeMaitre Single Lumen Embolectomy Catheter 4F, 80 cm, Model 1601-48 and e1601... Manufacturing issue that could cause a pinhole in the formed end of the packa... Class II
Oct 21, 2015 LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 6F, 80 cm, Model ... Manufacturing issue that could cause a pinhole in the formed end of the packa... Class II
Oct 21, 2015 LeMaitre Over-the-Wire Embolectomy Catheter 3F, 80cm, Model 1651-38. Indicat... Manufacturing issue that could cause a pinhole in the formed end of the packa... Class II
Oct 21, 2015 LeMaitre Over-the-Wire Embolectomy Catheter 6F, 40 cm, Model e-1651-64. Indi... Manufacturing issue that could cause a pinhole in the formed end of the packa... Class II

View all 70 device recalls →

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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