--- title: "LeMaitre Vascular, Inc. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search LeMaitre Vascular, Inc. recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/lemaitre-vascular-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # LeMaitre Vascular, Inc. recall records **10** reported ongoing 10 records in this archive. Latest source date Feb 10, 2026. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Feb 10, 2026 FDA device enforcement ### [Artegraft Vascular Graft; REF#: AG740;](https://isitonrecall.com/recall/fda-device-z-1574-2026-artegraft-vascular-graft-ref-ag740/) Labeling mix-up resulting in the incorrect lot outer packaging of product. Class II Reported ongoing Distribution: US Nationwide distribution in the state of IL. [Official source for Artegraft Vascular Graft; REF#: AG740;](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1574-2026%22) Sep 25, 2025 FDA device enforcement ### [Artegraft¿ Collagen Vascular Graft; REF: AG1015;](https://isitonrecall.com/recall/fda-device-z-0289-2026-artegraft-collagen-vascular-graft-ref-ag1015/) The device was incorrectly packed in the wrong size labeled outer packaging. Class II Reported ongoing Distribution: US distribution to the state of: AR [Official source for Artegraft¿ Collagen Vascular Graft; REF: AG1015;](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0289-2026%22) Sep 2, 2025 FDA device enforcement ### [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) A...](https://isitonrecall.com/recall/fda-device-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-7/) 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. Class II Reported ongoing 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. [Official source for Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640,...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0034-2026%22) Aug 25, 2025 FDA device enforcement ### [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...](https://isitonrecall.com/recall/fda-device-z-0072-2026-artegraft-collagen-vascular-graft-model-catalog-part-numbers-ag630m-ag636m-ag730m-ag740m-ag845m-the/) Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card. Class II Reported ongoing Distribution: No US distribution. International distribution to Great Britian and Switzerland. [Official source for Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, AG...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0072-2026%22) Apr 11, 2025 FDA device enforcement ### [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, E16...](https://isitonrecall.com/recall/fda-device-z-1750-2025-tuftex-over-the-wire-embolectomy-catheter-all-catalog-numbers-1651-34-1651-38-1651-44-1651-48-1651-5/) During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier). Class II Reported ongoing Distribution: Nationwide distribution. International distribution to ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, BULGARIA, CAMBODIA, CANADA, CHILE, COLOMBIA, COSTA RICA, CYPRUS, CZECHIA, ... [Official source for TufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651-38, 1651-44, 1651-4...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1750-2025%22) Apr 11, 2025 FDA device enforcement ### [Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56](https://isitonrecall.com/recall/fda-device-z-1751-2025-pruitt-occlusion-catheter-catalog-numbers-2103-36-2103-46-2103-56-e2103-36-e2103-46-e2103-56/) During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier). Class II Reported ongoing Distribution: Nationwide distribution. International distribution to ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, BULGARIA, CAMBODIA, CANADA, CHILE, COLOMBIA, COSTA RICA, CYPRUS, CZECHIA, ... [Official source for Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1751-2025%22) Apr 11, 2025 FDA device enforcement ### [Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09.](https://isitonrecall.com/recall/fda-device-z-1752-2025-pruitt-irrigation-occlusion-catheter-catalog-numbers-2102-09-e2102-09/) During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier). Class II Reported ongoing Distribution: Nationwide distribution. International distribution to ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, BULGARIA, CAMBODIA, CANADA, CHILE, COLOMBIA, COSTA RICA, CYPRUS, CZECHIA, ... [Official source for Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1752-2025%22) Apr 17, 2024 FDA device enforcement ### [Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies.](https://isitonrecall.com/recall/fda-device-z-1824-2024-syntel-silicone-thrombectomy-catheter-sterile-rx-only-used-in-vascular-grafts-and-peripheral-venous/) The guide tip can become damaged and result in the tip detaching. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Canada, and Spain. [Official source for Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral v...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1824-2024%22) Jul 13, 2023 FDA device enforcement ### [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 Valvuloto...](https://isitonrecall.com/recall/fda-device-z-2468-2023-the-chevalier-valvulotome-is-a-device-used-to-disrupt-the-valves-of-veins-which-are-to-be-used-as-gr/) Burrs (molding flash) on the cutter may tear the harvested vien Class II Reported ongoing Distribution: International distribution to the countries of Belgium, France, Germany, and United Kingdom. [Official source for The Chevalier Valvulotome is a device used to disrupt the valves of veins which are to be used as...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2468-2023%22) Sep 30, 2022 FDA device enforcement ### [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 th...](https://isitonrecall.com/recall/fda-device-z-0228-2023-tuftex-embolectomy-catheter-model-no-this-catheter-has-a-latex-balloon-and-a-single-lumen-extrusion/) 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 ... Class II Reported ongoing Distribution: No US distribution. Foreign distribution to United Kingdom, Germany, France, Sweden, Austria, and Italy. [Official source for TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extru...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0228-2023%22) ## Reasons in these listed records - Labeling mix-up resulting in the incorrect lot outer packaging of product. - The device was incorrectly packed in the wrong size labeled outer packaging. - 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. - Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card. These examples come from this result page and are not a ranking of every recall reason. ## Checking LeMaitre Vascular, Inc. ### Is there a recall on lemaitre vascular, inc. right now? This archive contains 10 records, including 10 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search LeMaitre Vascular, Inc.](https://isitonrecall.com/check/?q=LeMaitre%20Vascular%2C%20Inc.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)