LeMaitre Vascular, Inc.
LeMaitre Vascular, Inc. holds FDA 510(k) medical device clearances, first cleared 2003, most recent 2022, with 70 FDA device recalls on record.
Top product codes for LeMaitre Vascular, Inc.
FDA recalls by LeMaitre Vascular, Inc.
10 most recent of 70- Z-1574-2026 — Artegraft Vascular Graft; REF#: AG740;
- Z-0289-2026 — Artegraft¿ Collagen Vascular Graft; REF: AG1015;
- 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 1015, (15) AG 1030;
- 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 or diseased arterial segments is required or to establish a conduit for hemodialysis.
- Z-1751-2025 — Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56
- Z-1750-2025 — 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, 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.
- Z-1752-2025 — Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09.
- Z-1824-2024 — Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies.
- 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 shaft with two tips: 1) the cutting tip is shaped like an inverted tulip with four teeth at its base. This tip is designed to cut the vein valve cusps. 2) the other tip is atraumatic and used to test the patency and the course of the vein before the valvulotomy. The Chevalier Valvulotome is available in three tip diameters: 2.5 mm (Catalog # 40025); 3.0 mm (Catalog # 40030); and 3.5 mm (Catalog # 40035)
- 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..
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by LeMaitre Vascular, Inc.
- K212894 — PhasTIPP
- K183513 — XenoSure Dura Biologic Patch
- K173323 — AnastoClip GC Closure System
- K152833 — Pruitt F3-S Polyurethane Carotid Shunt
- K143454 — Pruitt F3-S Carotid Shunt
- K142660 — Antegrade LeMills Valvulotome
- K140042 — 1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME
- K133026 — UNBALLOON NON-OCCLUSION MODELING CATHETER
- K132022 — LEMAITRE 8F OCCLUSION CATHETER
- K132047 — LEMILLS VALVULOTOME
- K132190 — EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOME
- K130016 — LIFESPAN EPTFE VASCULAR GRAFT
- K123531 — UNBALLOON NON-OCCLUSIVE MODELING CATHETER
- K121415 — MOLLRING MULTITASC
- K121839 — UNBALLOON NON-OCCLUSIVE MODELING CATHETER
- K110891 — THE UNBALLOON NON-OCCLUSIVE CATHETER; THE UNBALLOON NON-OCCLUSIVE MODELING CATHETER
- K111884 — OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOME
- K103080 — ALBOGRAFT VASCULAR PROSTHESIS
- K103356 — PRUITT CAROTID KIT
- K101740 — ALBOSURE POLYESTER VASCULAR PATCH
- K091987 — ANASTOCLIP MODELS 4001-01, 4000-02, 4000-03, 4000-04, 4004-01, 4004-02, ANASTOCLIP
- K093231 — ALBOGRAFT VASCULAR PROSTHESIS
- K081878 — LEMAITRE TT TORTUOUS TRACKER INTRODUCER CATHETER DELIVERY SYSTEM
- K071367 — FLEXCEL CAROTID SHUNT (INLYING), MODEL 2020-05
- K051067 — PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT)
- K043023 — PRUITT-INAHARA OUTLYING CAROTID SHUNT, MODELS, 2012-49, 2013-49, 2014-49,2015-49,2016-49, 2017-49
- K033159 — LEMAITRE VASCULAR STRAIGHT CAROTID SHUNT, MODEL 2002-01, 2002-05, 2003-01, 2003-05, 2004-01, 2004-05, 2005-01, 2005-05
- K032041 — DISTAL PERFUSION CATHETER (1.5 CM) AND (2.5CM)
- K031282 — OPTILOCK IMPLANTABLE ACCESS PORT, MODEL 1700-05
- K021580 — OPTILOCK IMPLANTABLE ACCESS PORT, MODELS #1700-01, 1700-02, 1700-03, 1700-04 AND 1700-05
- K023688 — LEMAITRE VASCULAR DISPOSABLE VEIN STRIPPER
- K022145 — OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302
Data sourced from openFDA. This site is unofficial and independent of the FDA.