Burlington, MA, United States
LeMaitre Vascular, Inc. recalls
14 recalls recorded since 2018, most recently on 28 August 2026. 10 are listed as ongoing. Status and classification are as published by the FDA.
Recalls14
Ongoing (FDA)10
Terminated or completed4
Class I (FDA)1
Ongoing Class II Medical devices
- Recall started
- 28 August 2026
- Reason
- Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing.
- Distribution
- US Nationwide distribution in the states of CA, FL, GA, KY, LA, NJ, OH, PA, SC.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0117-2027
- TufTex¿ Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88;
Ongoing Class II Medical devices
- Recall started
- 10 February 2026
- Reason
- Labeling mix-up resulting in the incorrect lot outer packaging of product.
- Distribution
- US Nationwide distribution in the state of IL.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1574-2026
- Artegraft Vascular Graft; REF#: AG740;
Ongoing Class II Medical devices
- Recall started
- 25 September 2025
- Reason
- The device was incorrectly packed in the wrong size labeled outer packaging.
- Distribution
- US distribution to the state of: AR
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0289-2026
- Artegraft¿ Collagen Vascular Graft; REF: AG1015;
Ongoing Class II Medical devices
- Recall started
- 2 September 2025
- Reason
- The bovine carotid arteries used to produce the impacted grafts from affected lots were sourced using raw material from a supplier that had not been reviewed and approved by the appropriate regulatory authority.
- Distribution
- US Nationwide distribution in the states of CA, CT, FL, GA, IL, MA, MS, NC, ND, NJ, NY, OK, PA, TN, TX, VA, WA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0034-2026
- 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) AG 740, (10) AG 745, (11) AG 750, (12) AG 830, (13) AG 840, (14) AG 1
Ongoing Class II Medical devices
- Recall started
- 25 August 2025
- Reason
- Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.
- Distribution
- No US distribution. International distribution to Great Britian and Switzerland.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0072-2026
- Artegraft 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 o
Ongoing Class II Medical devices
- Recall started
- 11 April 2025
- Reason
- During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
- Distribution
- Nationwide distribution. International distribution to ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, BULGARIA, CAMBODIA, CANADA, CHILE, COLOMBIA, COSTA RICA, CYPRUS, CZECHIA, DENMARK, DOMINICAN REPUBLIC, EGYPT, EL SALVADOR, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, GUATEMALA, GUYANA, HON
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1751-2025, Z-1750-2025, Z-1752-2025
- Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56
- 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, 1651-88, E1651-34, E1651-38, E1651-44, E1651-48, E1651-64, E1651-68, E1
- Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09.
Ongoing Class II Medical devices
- Recall started
- 17 April 2024
- Reason
- The guide tip can become damaged and result in the tip detaching.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Canada, and Spain.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1824-2024
- Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies.
Ongoing Class II Medical devices
- Recall started
- 13 July 2023
- Reason
- Burrs (molding flash) on the cutter may tear the harvested vien
- Distribution
- International distribution to the countries of Belgium, France, Germany, and United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2468-2023
- 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 Chevalier Valvulotome consists of a 70 cm stainless steel shaf
Ongoing Class II Medical devices
- Recall started
- 30 September 2022
- Reason
- Three lots tied by two trainees were released without performing the required pull test. If tied with inadequate strength, the proximal ligature could slip toward the tip of the catheter and block the inflation hole, leading to the risk of the tip breaking off, and potentially becoming lost in the blood vessel.
- Distribution
- No US distribution. Foreign distribution to United Kingdom, Germany, France, Sweden, Austria, and Italy.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0228-2023
- TufTex 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..
Terminated Class II Medical devices
- Recall started
- 6 April 2021
- Terminated
- 29 December 2022
- Reason
- The firm received a complaint regarding particulate found in the packaging foam that could contaminate the sterile field.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AL, CA, FL, IL, IN, KY, MA, MO, NY, OH, TN, TX and the countries of Bahamas, Belgium, France, Germany, Hong Kong, Spain.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1529-2021
- LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Product Usage: intended to be used to perfuse contrast medias into the vessels for angiographic procedures, Catalog #: 4100-00.
Ongoing Class I Medical devices
- Recall started
- 23 March 2020
- Reason
- There has been an increased trend in reports of catheters failing to deflate during use, which may ultimately lead to tip separation.
- Distribution
- Worldwide distribution: US (Nationwide distribution) and foreign countries of: Australia, Austria, Belgium, Bulgaria, Colombia, Costa Rica, Czech Republic, Dominican Republic, Egypt, El Salvador, Estonia, Finland, France, Germany, Georgia, Hungary, Ireland, Israel, Italy, Japan, Korea, Netherlands,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1567-2020
- LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88, e1651-88. The LeMaitre Over the Wire Embolectomy Catheter is indicated for use in the removal of emboli and thrombi during em
Terminated Class II Medical devices
- Recall started
- 24 July 2019
- Terminated
- 11 May 2020
- Reason
- incorrect device size being listed on the impacted device packaging
- Distribution
- GERMANY FRANCE SLOVENIA SPAIN SWEDEN UK
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2448-2019
- 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 lumen acts as the inflation lumen for the balloon and is indicated by
Terminated Class II Medical devices
- Recall started
- 1 October 2018
- Terminated
- 10 April 2020
- Reason
- Pouches from this lot are not sealed compromising the sterility
- Distribution
- FL Foreign: Austalia, Korea
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0473-2019
- LeMaitre Vascular Pruitt F3¿-S Polyurethane Outlying Carotid Shunt, Sterile Model # 2014-10
Terminated Class II Medical devices
- Recall started
- 19 June 2018
- Terminated
- 17 April 2019
- Reason
- The wrong instructions for use (IFU) were supplied with the AnastoClip GC closure system. The IFU provided lists some indications which are not cleared by the FDA for devices distributed in the United States: 1) closure of arteriotomies and veinotomies, 2) attachment of synthetic vascular prostheses, and 3) approximation of dural tissue.
- Distribution
- Distributed to accounts in FL, NV, OK, SC, and TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3042-2018
- 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 closing of a vessel with possible intraluminal penetration.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.