LeMaitre Vascular Inc.
Burlington, MA, US
LEMAITRE VASCULAR, INC. appears in FDA device records in Burlington, MA. FDA records list 35 510(k) clearances between and , 41 PMA records and 3 registered establishments. As of , FDA records show 84 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 35 510(k) clearances for LeMaitre Vascular Inc. between 2003 and 2022. The busiest year on record is 2003, with 6. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 6 |
| 2004 | 1 |
| 2005 | 1 |
| 2007 | 1 |
| 2009 | 1 |
| 2010 | 4 |
| 2011 | 3 |
| 2012 | 3 |
| 2013 | 5 |
| 2014 | 2 |
| 2015 | 1 |
| 2016 | 1 |
| 2018 | 2 |
| 2019 | 2 |
| 2020 | 1 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K212894 | PhasTIPP | DWQ | Substantially Equivalent | |
| K190882 | XenoSure Biologic Patch | PSQ | Substantially Equivalent | |
| K190267 | EZE SIT Valvulotome | MGZ | Substantially Equivalent | |
| K183513 | XenoSure Dura Biologic Patch | GXQ | Substantially Equivalent | |
| K182916 | Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr | MJN | Substantially Equivalent | |
| K173323 | AnastoClip GC Closure System | FZP | Substantially Equivalent | |
| K152833 | Pruitt F3-S Polyurethane Carotid Shunt | MJN | Substantially Equivalent | |
| K143454 | Pruitt F3-S Carotid Shunt | MJN | Substantially Equivalent | |
| K142660 | Antegrade LeMills Valvulotome | MGZ | Substantially Equivalent | |
| K140042 | 1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME | MGZ | Substantially Equivalent | |
| K133026 | UNBALLOON NON-OCCLUSION MODELING CATHETER | DQY | Substantially Equivalent | |
| K132022 | LEMAITRE 8F OCCLUSION CATHETER | MJN | Substantially Equivalent | |
| K132047 | LEMILLS VALVULOTOME | MGZ | Substantially Equivalent | |
| K132190 | EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOME | MGZ | Substantially Equivalent | |
| K130016 | LIFESPAN EPTFE VASCULAR GRAFT | DSY | Substantially Equivalent | |
| K123531 | UNBALLOON NON-OCCLUSIVE MODELING CATHETER | DQY | Substantially Equivalent | |
| K121415 | MOLLRING MULTITASC | DWX | Substantially Equivalent | |
| K121839 | UNBALLOON NON-OCCLUSIVE MODELING CATHETER | DQY | Substantially Equivalent | |
| K110891 | THE UNBALLOON NON-OCCLUSIVE CATHETER; THE UNBALLOON NON-OCCLUSIVE MODELING CATHETER | DQY | Substantially Equivalent | |
| K111884 | OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOME | MGZ | Substantially Equivalent | |
| K103080 | ALBOGRAFT VASCULAR PROSTHESIS | MAL | Substantially Equivalent | |
| K103356 | PRUITT CAROTID KIT | MJN | Substantially Equivalent | |
| K101740 | ALBOSURE POLYESTER VASCULAR PATCH | DXZ | Substantially Equivalent | |
| K091987 | ANASTOCLIP MODELS 4001-01, 4000-02, 4000-03, 4000-04, 4004-01, 4004-02, ANASTOCLIP | FZP | Substantially Equivalent | |
| K093231 | ALBOGRAFT VASCULAR PROSTHESIS | MAL | Substantially Equivalent | |
| K081878 | LEMAITRE TT TORTUOUS TRACKER INTRODUCER CATHETER DELIVERY SYSTEM | DQY | Substantially Equivalent | |
| K071367 | FLEXCEL CAROTID SHUNT (INLYING), MODEL 2020-05 | MJN | Substantially Equivalent | |
| K051067 | PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT) | MJN | Substantially Equivalent | |
| K043023 | PRUITT-INAHARA OUTLYING CAROTID SHUNT, MODELS, 2012-49, 2013-49, 2014-49,2015-49,2016-49, 2017-49 | MJN | Substantially Equivalent | |
| K033159 | LEMAITRE VASCULAR STRAIGHT CAROTID SHUNT, MODEL 2002-01, 2002-05, 2003-01, 2003-05, 2004-01, 2004-05, 2005-01, 2005-05 | MJN | Substantially Equivalent | |
| K032041 | DISTAL PERFUSION CATHETER (1.5 CM) AND (2.5CM) | DWF | Substantially Equivalent | |
| K031282 | OPTILOCK IMPLANTABLE ACCESS PORT, MODEL 1700-05 | LJT | Substantially Equivalent | |
| K021580 | OPTILOCK IMPLANTABLE ACCESS PORT, MODELS #1700-01, 1700-02, 1700-03, 1700-04 AND 1700-05 | LJT | Substantially Equivalent | |
| K023688 | LEMAITRE VASCULAR DISPOSABLE VEIN STRIPPER | GAF | Substantially Equivalent | |
| K022145 | OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302 | DXE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1220948 | 1220948 | LEMAITRE VASCULAR, INC. | 63 SECOND AVENUE, BURLINGTON, MA 01803 US | 2026 | and 9 more, listed in full below |
| 2247686 | 1000121696 | LEMAITRE VASCULAR, INC. | 206 NORTH CENTER DR., N Brunswick, NJ 08902 US | 2026 | |
| 3045042524 | 3045042524 | LeMaitre Vascular Inc. | 47 Dunham Rd, Billerica, MA 01821 US | 2026 | and 9 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HBTApplier, Hemostatic Clip
- KFXAssembly, Thigh/Knee/Shank/Ankle/Foot, External
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- KRACatheter, Continuous Flush
- DXECatheter, Embolectomy
- DYGCatheter, Flow Directed
- MJNCatheter, Intravascular Occluding, Temporary
- DQYCatheter, Percutaneous
- FZPClip, Implantable
- GXQDura Substitute
- HTDForceps
- MALGraft, Vascular, Synthetic/Biologic Composite
- PSQIntracardiac Patch Or Pledget, Biologically Derived
- FTMMesh, Surgical
- DQTOccluder, Catheter Tip
- DXZPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
- LJTPort & Catheter, Implanted, Subcutaneous, Intravascular
- DSYProsthesis, Vascular Graft, Of 6mm And Greater Diameter
- GAFSpatula, Surgical, General & Plastic Surgery
- DWXStripper, Artery, Intraluminal
- DWQStripper, Vein, External
- LXATissue Graft Of 6mm And Greater
- MGZValvulotome
- MFXVessel Guard Or Cover, To Facilitate Revision Surgeries
Recall records
Showing 25 of 84| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1574-2026 | Artegraft Vascular Graft; REF#: AG740; | Labeling mix-up resulting in the incorrect lot outer packaging of product. | Class II | Open, Classified | |
| Z-0289-2026 | Artegraft Collagen Vascular Graft; REF: AG1015; | The device was incorrectly packed in the wrong size labeled outer packaging. | Class II | Open, Classified | |
| 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; | 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 | Open, Classified | |
| 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. | Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card. | Class II | Open, Classified | |
| 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 | Open, Classified | |
| 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 | Open, Classified | |
| 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. | During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier). | Class II | Open, Classified | |
| Z-1824-2024 | Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies. | The guide tip can become damaged and result in the tip detaching. | Class II | Open, Classified | |
| 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) | Burrs (molding flash) on the cutter may tear the harvested vien | Class II | Open, Classified | |
| 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.. | 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. | Class II | Open, Classified | |
| 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. | The firm received a complaint regarding particulate found in the packaging foam that could contaminate the sterile field. | Class II | Terminated | |
| 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 embolectomy and/or thrombectomy. It can also be used for catheter placement over a guidewire, vessel occlusion, fluid infusion and/or aspiration. | There has been an increased trend in reports of catheters failing to deflate during use, which may ultimately lead to tip separation. | Class I | Open, Classified | |
| 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 the white stopcock. Other features include a balloon wall thickness designed to reduce the possibility of puncture by calcium deposits, and a stop-cock to maintain balloon inflation level throughout the procedure. | incorrect device size being listed on the impacted device packaging | Class II | Terminated | |
| Z-0473-2019 | LeMaitre Vascular Pruitt F3-S Polyurethane Outlying Carotid Shunt, Sterile Model # 2014-10 | Pouches from this lot are not sealed compromising the sterility | Class II | Terminated | |
| 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. | 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. | Class II | Terminated | |
| Z-1453-2017 | LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter with Introducer (paper IFU) REF# 2401-53 | The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch | Class II | Terminated | |
| Z-1452-2017 | LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-53 | The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch | Class II | Terminated | |
| Z-1451-2017 | LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (paper IFU) REF# 2401-52 | The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch | Class II | Terminated | |
| Z-1450-2017 | LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-52 | The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch | Class II | Terminated | |
| Z-1449-2017 | LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (paper IFU) REF# 2401-51 | The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch | Class II | Terminated | |
| Z-1448-2017 | LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-51 | The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch | Class II | Terminated | |
| Z-1447-2017 | LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter (paper IFU) REF# 2401-50 | The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch | Class II | Terminated | |
| Z-1446-2017 | LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter (eIFU) REF# e2401-50 | The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch | Class II | Terminated | |
| Z-1445-2017 | LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (eIFU) REF # e2400-53 | The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch | Class II | Terminated | |
| Z-1444-2017 | LeMaitre Vascular Reddick Cholangiogram Catheter with introducer(eIFU) REF # e2400-52 | The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain