Data / Medical devices / United States / Lemaitre Vascular, Inc.
Lemaitre Vascular, Inc.: FDA-registered device maker in Burlington, MA, United States, 29 510(k) clearances
Lemaitre Vascular, Inc. is registered with the FDA (registration 1220948) in Burlington, MA, United States. It lists 19 device types. The FDA files 29 510(k) clearances under its listings, the newest dated March 31, 2022. 23 recall events name it as the recalling firm (2 Class I). Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1220948
- Address
- 63 Second Avenue, Burlington, MA, United States, 01803
- Owner or operator
- LEMAITRE VASCULAR, INC. (1220948)
- Roles
- Manufacturer
- First device listed
- April 25, 2001
- Registered through
- 2027
- Brand names listed
- Albograft Vascular Grafts, AnastoClip AC Closure System, AnastoClip Atraumatic Forceps, AnastoClip GC (GripClip), AnastoClip GC Closure System, CardioCel Cardiovascular Patch, DISTAL PERFUSION CATHETER, DuraSure Biologic Patch and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 31, 2022 | K212894 | PhasTIPP | DWQ | Substantially Equivalent | LeMaitre Vascular, Inc. | accessdata.fda.gov |
| September 7, 2021 | K202049 | Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter | DXE | Substantially Equivalent | Applied Medical Resources Corporation | accessdata.fda.gov |
| February 13, 2020 | K190882 | XenoSure Biologic Patch | PSQ | Substantially Equivalent | Lemaitre Vascular | accessdata.fda.gov |
| October 30, 2019 | K190267 | EZE SIT Valvulotome | MGZ | Substantially Equivalent | Lemaitre Vascular | accessdata.fda.gov |
| June 13, 2019 | K183513 | XenoSure Dura Biologic Patch | GXQ | Substantially Equivalent | LeMaitre Vascular, Inc. | accessdata.fda.gov |
| November 16, 2018 | K182916 | Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr | MJN | Substantially Equivalent | Lemaitre Vascular | accessdata.fda.gov |
| March 8, 2018 | K173323 | AnastoClip GC Closure System | FZP | Substantially Equivalent | LeMaitre Vascular, Inc. | accessdata.fda.gov |
| October 14, 2016 | K162579 | VascuCel | DXZ | Substantially Equivalent | Admedus Regen Pty, Ltd. | accessdata.fda.gov |
| January 21, 2016 | K152833 | Pruitt F3-S Polyurethane Carotid Shunt | MJN | Substantially Equivalent | LeMaitre Vascular, Inc. | accessdata.fda.gov |
| April 10, 2014 | K140042 | 1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME | MGZ | Substantially Equivalent | LeMaitre Vascular, Inc. | accessdata.fda.gov |
| January 30, 2014 | K130872 | CARDIOCEL | DXZ | Substantially Equivalent | Celxcel Pty, Ltd. | accessdata.fda.gov |
| November 5, 2013 | K132047 | LEMILLS VALVULOTOME | MGZ | Substantially Equivalent | LeMaitre Vascular, Inc. | accessdata.fda.gov |
| February 5, 2013 | K130016 | LIFESPAN EPTFE VASCULAR GRAFT | DSY | Substantially Equivalent | LeMaitre Vascular, Inc. | accessdata.fda.gov |
| July 29, 2011 | K111884 | OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOME | MGZ | Substantially Equivalent | LeMaitre Vascular, Inc. | accessdata.fda.gov |
| April 23, 2010 | K091987 | ANASTOCLIP MODELS 4001-01, 4000-02, 4000-03, 4000-04, 4004-01, 4004-02, ANASTOCLIP | FZP | Substantially Equivalent | LeMaitre Vascular, Inc. | accessdata.fda.gov |
| January 14, 2010 | K093231 | ALBOGRAFT VASCULAR PROSTHESIS | MAL | Substantially Equivalent | LeMaitre Vascular, Inc. | accessdata.fda.gov |
| August 29, 2007 | K071367 | FLEXCEL CAROTID SHUNT (INLYING), MODEL 2020-05 | MJN | Substantially Equivalent | LeMaitre Vascular, Inc. | accessdata.fda.gov |
| May 27, 2005 | K051067 | PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT) | MJN | Substantially Equivalent | LeMaitre Vascular, Inc. | accessdata.fda.gov |
| June 15, 2004 | K040835 | PERIPATCH SHEET, MODELS 1.5P8, 1.5P16, 4P4, 4P6, 6P8 AND 10P16 | FTM | Substantially Equivalent | Pm Devices, Inc. | accessdata.fda.gov |
| August 27, 2003 | K032041 | DISTAL PERFUSION CATHETER (1.5 CM) AND (2.5CM) | DWF | Substantially Equivalent | LeMaitre Vascular, Inc. | accessdata.fda.gov |
| January 14, 2003 | K022145 | OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302 | DXE | Substantially Equivalent | LeMaitre Vascular, Inc. | accessdata.fda.gov |
| December 9, 1999 | K992368 | LEMAITRE EMBOLECTOMY CATHETER | DXE | Substantially Equivalent | Vascutech, Inc. | accessdata.fda.gov |
| March 28, 1997 | K970762 | DUAL LUMEN EMBOLECTOMY CATHETER | DXE | Substantially Equivalent | Applied Medical Resources | accessdata.fda.gov |
| September 23, 1996 | K962043 | AUTO SUTURE MODIFIED VCS CLIP APPLIER | FZP | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| July 22, 1993 | K932184 | STERILE LEMAITRE GLOW 'N TELL TAPE | KFX | Substantially Equivalent | Vascutech, Inc. | accessdata.fda.gov |
| April 26, 1991 | K910372 | INTIMAX THROMBECTOMY CATHETER | DXE | Substantially Equivalent | Applied Vascular Devices, Inc. | accessdata.fda.gov |
| May 25, 1988 | K880231 | MODIFIED PRUITT IRRIGATION & OCCLUSION CATHETER | DQT | Substantially Equivalent | Ideas For Medicine, Inc. | accessdata.fda.gov |
| October 30, 1987 | K872090 | THE ROBICSEK - PRUITT AORTIC BALLOON OCCLUSION KIT | DQT | Substantially Equivalent | Ideas For Medicine, Inc. | accessdata.fda.gov |
| June 30, 1981 | K811276 | OCCLUSION CATHETER | DYG | Substantially Equivalent | Bionomy, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 28, 2026 | 99836 | Class II | Ongoing | TufTex Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88 | Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing. | accessdata.fda.gov |
| April 11, 2025 | 96716 | Class II | Ongoing | 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- | During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier). | accessdata.fda.gov |
| April 17, 2024 | 94457 | Class II | Ongoing | 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. | accessdata.fda.gov |
| July 13, 2023 | 92825 | Class II | Ongoing | 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 | Burrs (molding flash) on the cutter may tear the harvested vien | accessdata.fda.gov |
| September 30, 2022 | 91006 | Class II | Ongoing | 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. | accessdata.fda.gov |
| April 6, 2021 | 87689 | Class II | Terminated | 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. | accessdata.fda.gov |
| March 23, 2020 | 85193 | Class I | Ongoing | 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 embol | There has been an increased trend in reports of catheters failing to deflate during use, which may ultimately lead to tip separation. | accessdata.fda.gov |
| July 24, 2019 | 83535 | Class II | Terminated | 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 | incorrect device size being listed on the impacted device packaging | accessdata.fda.gov |
| October 1, 2018 | 81391 | Class II | Terminated | LeMaitre Vascular Pruitt F3-S Polyurethane Outlying Carotid Shunt, Sterile Model # 2014-10 | Pouches from this lot are not sealed compromising the sterility | accessdata.fda.gov |
| June 19, 2018 | 80627 | Class II | Terminated | 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. | accessdata.fda.gov |
| February 7, 2017 | 76476 | Class II | Terminated | LeMaitre Vascular Reddick Cholangiogram Catheter (eIFU) REF# e2400-50 | The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch | accessdata.fda.gov |
| August 3, 2016 | 74880 | Class II | Terminated | 1.5 mm HYDRO LeMaitre Valvulotome, 98 cm, Sterile REF # 1009-00 Product Usage: The HYDRO LeMaitre Valvulotome is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous va | Wire which deploys the loop may be come detached at the handle causing the device to be inoperable | accessdata.fda.gov |
| June 22, 2016 | 74563 | Class II | Terminated | Anastoclip AC 8cm 35 Clips (1 Each} Medium REF # 4000-06 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to | US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use | accessdata.fda.gov |
| October 21, 2015 | 72534 | Class II | Terminated | LeMaitre Over-the-Wire Embolectomy Catheter 3F, 40cm, Model 1651-34 and e1651-34. Indicated for the removal of arterial emboli and thrombi. | Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. | accessdata.fda.gov |
| February 24, 2015 | 70698 | Class III | Terminated | LeMaitre Vascular Tumescent Catheter Inversion (TCI) System. The TCI System is intended to provide a system to the removal of an incompetent greater saphenous vein. Catalog Number: 7210023, lot #61049252 | Mislabeled with an incorrect expiration date | accessdata.fda.gov |
| June 17, 2013 | 65553 | Class I | Terminated | AlboGraft Knitted with Collagen, Bifurcate 14x08 Catalog Number: AMC1408 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries. | Blood blushing/leaking from the surface of the graft after implantation | accessdata.fda.gov |
| March 18, 2013 | 64704 | Class II | Terminated | LeMaitre Stent Guide: 1102-00 (100 strips); 1102-50 (50 strips); 1102-20 (20 strips). Intended to be placed on the skin to assist during imaging procedures. | Devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised. | accessdata.fda.gov |
| October 4, 2011 | 60007 | Not yet classified | Terminated | LeMaitre 9F Pruitt F3 Outlying Carotid Shunt with T-port The Pruitt F3 Carotid Shunt (the Shunt) is a multi-lumen device with balloons at both the distal (internal carotid) and proximal (common carotid) ends of the shunt | Extended Expiration on the outer box label 2016-05, the correct expiration date is on the tray label: 2014-05 | accessdata.fda.gov |
| October 22, 2010 | 57028 | Not yet classified | Terminated | LeMaitre VascuTape Radiopaque Tape, LeMaitre Stent Guide, 20 strips Catalog Number: 1102-20 Intended to be placed on the patient's skin to assist during imaging procedures by serving as an internal frame of reference. | Box label (Top Part). Lot and Expiration Date information were switched. | accessdata.fda.gov |
| September 22, 2010 | 56908 | Not yet classified | Terminated | LeMaitre Vascular AnastoClip GC Vessel Closure System-Medium Size Models: 4007-02 Medium size 3 Pack 4008-02 Medium size 10 Pack 4007-06 Medium size 1 Pack Manufactured by LeMatire Vascular Inc, Burlington, MA 01803 | Mislabeled size on external packaging: The contents section listed on the Tyvek lid labels of the Medium and Large sizes incorrectly identified the size of the clip as XL, while the device inside was either a Medium or Large size. | accessdata.fda.gov |
| July 18, 2007 | 38894 | Not yet classified | Terminated | CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedures. Ref : OZ 1035 (Cardiovascular Innovations LLC) | Sterility of device may be compromised due to breach in sterile barrier. | accessdata.fda.gov |
| May 17, 2005 | 32971 | Not yet classified | Terminated | Product is a Pruitt Aortic Occlusion Catheter contained in a molded tray. The product is labeled in part: ''***LeMaitre VASCULAR***Distributed By:LeMaitre Vascular, Inc.***Manufactured By: LeMaitre Vascular, Inc. 3101 37 | LeMaitre Vascular is recalling certain lots of its Pruitt Aortic Occlusion Catheters due to a packaging defect which could compromise product sterility. | accessdata.fda.gov |
| February 7, 2005 | 31108 | Not yet classified | Terminated | LeMaitre Embolectomy Catheter 2F Single Lumen, Balloon Volume 0.05 ml, Length 60 cm. Latex Model: 1601-26 | Product sterility maybe compromised due to defective packaging | accessdata.fda.gov |
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Updated October 7, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.