LeMaitre Vascular, Inc.

Medical device manufacturer in North Brunswick, NJ.

35510(k) clearances
1PMA approvals
78recalls

Device types

510(k) clearances

510(k)DeviceDecision
K212894PhasTIPPDWQ · Traditional 03/31/2022SE
K190882XenoSure Biologic PatchPSQ · Traditional 02/13/2020SE
K190267EZE SIT ValvulotomeMGZ · Traditional 10/30/2019SE
K183513XenoSure Dura Biologic PatchGXQ · Traditional 06/13/2019SE
K182916Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt…MJN · Special 11/16/2018SE
K173323AnastoClip GC Closure SystemFZP · Traditional 03/08/2018SE
K152833Pruitt F3-S Polyurethane Carotid ShuntMJN · Traditional 01/21/2016SE
K143454Pruitt F3-S Carotid ShuntMJN · Traditional 08/27/2015SE
K142660Antegrade LeMills ValvulotomeMGZ · Special 10/17/2014SE
K1400421.5MM Hydro Expandable Lemaitre ValvulotomeMGZ · Traditional 04/10/2014SE
K133026Unballoon Non-Occlusion Modeling CatheterDQY · Traditional 12/31/2013SE
K132022Lemaitre 8F Occlusion CatheterMJN · Traditional 11/06/2013SE
K132047Lemills ValvulotomeMGZ · Traditional 11/05/2013SE
K132190Expandable Lemaitre Valvulotome, Over-The-Wire Lemaitre ValvulotomeMGZ · Traditional 08/05/2013SE
K130016Lifespan Eptfe Vascular GraftDSY · Special 02/05/2013SE
K123531Unballoon Non-Occlusive Modeling CatheterDQY · Special 12/14/2012SE
K121415Mollring MultitascDWX · Traditional 09/05/2012SE
K121839Unballoon Non-Occlusive Modeling CatheterDQY · Special 08/08/2012SE
K110891The Unballoon Non-Occlusive Catheter; the Unballoon Non-Occlusive Modeling CatheterDQY · Traditional 09/13/2011SE
K111884Over-The-Wire Expandable Lemaitre ValvulotomeMGZ · Special 07/29/2011SE
K103080Albograft Vascular ProsthesisMAL · Traditional 01/19/2011SE
K103356Pruitt Carotid KitMJN · Special 12/08/2010SE
K101740Albosure Polyester Vascular PatchDXZ · Traditional 09/20/2010SE
K091987Anastoclip Models 4001-01, 4000-02, 4000-03, 4000-04, 4004-01, 4004-02, AnastoclipFZP · Traditional 04/23/2010SE
K093231Albograft Vascular ProsthesisMAL · Traditional 01/14/2010SE
K081878Lemaitre TT Tortuous Tracker Introducer Catheter Delivery SystemDQY · Traditional 01/27/2009SE
K071367Flexcel Carotid Shunt (Inlying), Model 2020-05MJN · Special 08/29/2007SE
K051067Pruitt F3 Outlying and Inlying Carotid Shunt (with and Without T-Port)MJN · Special 05/27/2005SE
K043023Pruitt-Inahara Outlying Carotid Shunt, Models, 2012-49, 2013-49…MJN · Special 12/03/2004SE
K033159Lemaitre Vascular Straight Carotid Shunt, Model 2002-01, 2002-05, 2003-01, 2003-05…MJN · Traditional 12/19/2003SE
K032041Distal Perfusion Catheter (1.5 CM) and (2.5CM)DWF · Traditional 08/27/2003SE
K031282Optilock Implantable Access Port, Model 1700-05LJT · Traditional 08/05/2003SE
K021580Optilock Implantable Access Port, Models #1700-01, 1700-02, 1700-03, 1700-04 and 1700-05LJT · Traditional 02/12/2003SE
K023688Lemaitre Vascular Disposable Vein StripperGAF · Traditional 01/30/2003SE
K022145Over the Wire Embolectomy Catheter, Model 2302DXE · Traditional 01/14/2003SE

PMA approvals

Recalls

RecallProductInitiated
Z-1574-2026 Class IIArtegraft Vascular Graft; REF#: AG740;Labeling mix-up resulting in the incorrect lot outer packaging of product. 02/10/2026Open, Classified
Z-0289-2026 Class IIArtegraft Collagen Vascular Graft; REF: AG1015;The device was incorrectly packed in the wrong size labeled outer packaging. 09/25/2025Open, Classified
Z-0034-2026 Class IIArtegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636…The bovine carotid arteries used to produce the impacted grafts from affected lots were sourced using raw… 09/02/2025Open, Classified
Z-0072-2026 Class IIArtegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M…Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient… 08/25/2025Open, Classified
Z-1752-2025 Class IIPruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09.During internal product testing, it was observed that some packages to have incomplete seals (sterile… 04/11/2025Open, Classified
Z-1751-2025 Class IIPruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36…During internal product testing, it was observed that some packages to have incomplete seals (sterile… 04/11/2025Open, Classified
Z-1750-2025 Class IITufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651-38…During internal product testing, it was observed that some packages to have incomplete seals (sterile… 04/11/2025Open, Classified
Z-1824-2024 Class IISyntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and…The guide tip can become damaged and result in the tip detaching. 04/17/2024Open, Classified
Z-2468-2023 Class IIThe Chevalier Valvulotome is a device used to disrupt the valves of veins which are to…Burrs (molding flash) on the cutter may tear the harvested vien 07/13/2023Open, Classified
Z-0228-2023 Class IITufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single…Three lots tied by two trainees were released without performing the required pull test. If tied with… 09/30/2022Open, Classified
Z-1529-2021 Class IILeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Product…The firm received a complaint regarding particulate found in the packaging foam that could contaminate the… 04/06/2021Terminated
Z-1567-2020 Class ILeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84…There has been an increased trend in reports of catheters failing to deflate during use, which may… 03/23/2020Open, Classified
Z-2448-2019 Class IIThe LeMaitre Aortic Occlusion Catheter is a single lumen catheter with a latex balloon…incorrect device size being listed on the impacted device packaging 07/24/2019Terminated
Z-0473-2019 Class IILeMaitre Vascular Pruitt F3-S Polyurethane Outlying Carotid Shunt, Sterile Model # 2014-10Pouches from this lot are not sealed compromising the sterility 10/01/2018Terminated
Z-3042-2018 Class IIAnastoClip GC Closure System, REF# 4007-08 a closure system designed to penetrate the…The wrong instructions for use (IFU) were supplied with the AnastoClip GC closure system. The IFU provided… 06/19/2018Terminated
Z-1453-2017 Class IILeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter with Introducer…The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch 02/07/2017Terminated
Z-1452-2017 Class IILeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-53The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch 02/07/2017Terminated
Z-1451-2017 Class IILeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (paper IFU) REF#…The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch 02/07/2017Terminated
Z-1450-2017 Class IILeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-52The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch 02/07/2017Terminated
Z-1449-2017 Class IILeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (paper IFU)…The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch 02/07/2017Terminated
Z-1448-2017 Class IILeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF#…The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch 02/07/2017Terminated
Z-1447-2017 Class IILeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter (paper IFU) REF#…The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch 02/07/2017Terminated
Z-1446-2017 Class IILeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter (eIFU) REF# e2401-50The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch 02/07/2017Terminated
Z-1445-2017 Class IILeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (eIFU) REF #…The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch 02/07/2017Terminated
Z-1444-2017 Class IILeMaitre Vascular Reddick Cholangiogram Catheter with introducer(eIFU) REF # e2400-52The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch 02/07/2017Terminated
Z-1443-2017 Class IILeMaitre Vascular Reddick Cholangiogram Stiffer Catheter (eIFU) REF# e2400-51The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch 02/07/2017Terminated
Z-1442-2017 Class IILeMaitre Vascular Reddick Cholangiogram Catheter (eIFU) REF# e2400-50The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch 02/07/2017Terminated
Z-2545-2016 Class II1.5 mm HYDRO LeMaitre Valvulotome, 40 cm. Sterile REF # 1010-00 Product Usage: The HYDRO…Wire which deploys the loop may be come detached at the handle causing the device to be inoperable 08/03/2016Terminated
Z-2544-2016 Class II1.5 mm HYDRO LeMaitre Valvulotome without LeMills, 98 cm. Sterile REF# 1009-00J Product…Wire which deploys the loop may be come detached at the handle causing the device to be inoperable 08/03/2016Terminated
Z-2543-2016 Class II1.5 mm HYDRO LeMaitre Valvulotome, 98 cm, Sterile REF # 1009-00 Product Usage: The HYDRO…Wire which deploys the loop may be come detached at the handle causing the device to be inoperable 08/03/2016Terminated
Z-2289-2016 Class IIAnastoCiip Universal Clip Remover (1Each} REF# e4001-04 The Anastoclip Clip applier…US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be… 06/22/2016Terminated
Z-2288-2016 Class IIAnastoCiip Universal Clip Remover (6 Pack} REF# e4001-00 The Anastoclip Clip applier…US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be… 06/22/2016Terminated
Z-2287-2016 Class IIAnastoCiip Universal Clip Remover (1Each} REF# 4001-04 The Anastoclip Clip applier…US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be… 06/22/2016Terminated
Z-2286-2016 Class IIAnastoCiip Universal Clip Remover (6 Pack} REF# 4001-00 The Anastoclip Clip applier…US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be… 06/22/2016Terminated
Z-2285-2016 Class IIAnasto AC Closure System and Anasto Universal Clip Remover- Anasto AC 8cm 25 Clips (1…US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be… 06/22/2016Terminated
Z-2284-2016 Class IIAnastoClip AC 8cm 35 Clips (1 Each} Large REF # 4000-07 The Anastoclip Clip applier…US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be… 06/22/2016Terminated
Z-2283-2016 Class IIAnastoclip AC 8cm 35 Clips (1 Each} Medium REF # 4000-06 The Anastoclip Clip applier…US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be… 06/22/2016Terminated
Z-0390-2016 Class IILeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 2F, 60 cm, Model e1801-26.…Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to… 10/21/2015Terminated
Z-0389-2016 Class IILeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 6F, 80 cm, Model 1601-68.…Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to… 10/21/2015Terminated
Z-0388-2016 Class IILeMaitre Single Lumen Embolectomy Catheter 5F, 80 cm, Model 1601-58 and e1601-58.…Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to… 10/21/2015Terminated
Z-0387-2016 Class IILeMaitre Single Lumen Embolectomy Catheter 4F, 80 cm, Model 1601-48 and e1601-48.…Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to… 10/21/2015Terminated
Z-0386-2016 Class IILeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm, Model 1601-38 and e1601-38.…Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to… 10/21/2015Terminated
Z-0385-2016 Class IILeMaitre Over-the-Wire Embolectomy Catheter 6F, 80 cm, Model e-1651-68. Indicated for…Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to… 10/21/2015Terminated
Z-0384-2016 Class IILeMaitre Over-the-Wire Embolectomy Catheter 6F, 40 cm, Model e-1651-64. Indicated for…Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to… 10/21/2015Terminated
Z-0383-2016 Class IILeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 40 cm, Model e1651-84. Indicated…Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to… 10/21/2015Terminated
Z-0382-2016 Class IILeMaitre Over-the-Wire Embolectomy Catheter 7F, 80cm, Model 1654-78 and e1654-78.…Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to… 10/21/2015Terminated
Z-0381-2016 Class IILeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 80cm, Model 1651-88 and e1654-88.…Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to… 10/21/2015Terminated
Z-0380-2016 Class IILeMaitre Over-the-Wire Embolectomy Catheter 4F, 80cm, Model 1651-48 and e1654-48.…Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to… 10/21/2015Terminated
Z-0379-2016 Class IILeMaitre Over-the-Wire Embolectomy Catheter 3F, 80cm, Model 1651-38. Indicated for the…Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to… 10/21/2015Terminated
Z-0378-2016 Class IILeMaitre Over-the-Wire Embolectomy Catheter 3F, 40cm, Model 1651-34 and e1651-34.…Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to… 10/21/2015Terminated
Z-1294-2015 Class IIILeMaitre Vascular Tumescent Catheter Inversion (TCI) System. The TCI System is intended…Mislabeled with an incorrect expiration date 02/24/2015Terminated
Z-1770-2013 Class IAlboGraft Woven with Collagen, Straight 30x26 Catalog Number: ATC3026 AlboGraft Vascular…Blood blushing/leaking from the surface of the graft after implantation 06/17/2013Terminated
Z-1769-2013 Class IAlboGraft Woven with Collagen, Straight 30x24 Catalog Number: ATC3024 AlboGraft Vascular…Blood blushing/leaking from the surface of the graft after implantation 06/17/2013Terminated
Z-1768-2013 Class IAlboGraft Woven with Collagen, Straight 30x18 Catalog Number: ATC3018 AlboGraft Vascular…Blood blushing/leaking from the surface of the graft after implantation 06/17/2013Terminated
Z-1767-2013 Class IAlboGraft Woven with Collagen, Straight 30x16 Catalog Number: ATC3016 AlboGraft Vascular…Blood blushing/leaking from the surface of the graft after implantation 06/17/2013Terminated
Z-1766-2013 Class IAlboGraft Woven with Collagen, Straight 15x30 Catalog Number: ATC1530 AlboGraft Vascular…Blood blushing/leaking from the surface of the graft after implantation 06/17/2013Terminated
Z-1765-2013 Class IAlboGraft Woven with Collagen, Straight 15x26 Catalog Number: ATC1526 AlboGraft Vascular…Blood blushing/leaking from the surface of the graft after implantation 06/17/2013Terminated
Z-1764-2013 Class IAlboGraft Knitted with Collagen, Straight 60x08 Catalog Number: AMC6008 AlboGraft…Blood blushing/leaking from the surface of the graft after implantation 06/17/2013Terminated
Z-1763-2013 Class IAlboGraft Knitted with Collagen, Straight 60x07 Catalog Number: AMC6007 AlboGraft…Blood blushing/leaking from the surface of the graft after implantation 06/17/2013Terminated
Z-1762-2013 Class IAlboGraft Knitted with Collagen, Straight 60x06 Catalog Number: AMC6006 AlboGraft…Blood blushing/leaking from the surface of the graft after implantation 06/17/2013Terminated
Z-1761-2013 Class IAlboGraft Knitted with Collagen, Straight 40x08 Catalog Number: AMC4008 AlboGraft…Blood blushing/leaking from the surface of the graft after implantation 06/17/2013Terminated
Z-1760-2013 Class IAlboGraft Knitted with Collagen, Straight 40x07 Catalog Number: AMC4007 AlboGraft…Blood blushing/leaking from the surface of the graft after implantation 06/17/2013Terminated
Z-1759-2013 Class IAlboGraft Knitted with Collagen, Bifurcate 20x10Catalog Number: AMC2010 AlboGraft…Blood blushing/leaking from the surface of the graft after implantation 06/17/2013Terminated
Z-1758-2013 Class IAlboGraft Knitted with Collagen, Bifurcate 18x10 Catalog Number: AMC1810 AlboGraft…Blood blushing/leaking from the surface of the graft after implantation 06/17/2013Terminated
Z-1757-2013 Class IAlboGraft Knitted with Collagen, Bifurcate 18x09 Catalog Number: AMC1809 AlboGraft…Blood blushing/leaking from the surface of the graft after implantation 06/17/2013Terminated
Z-1756-2013 Class IAlbo Graft Knitted with Collagen, Bifurcate 16x08 Catalog Number: AMC1608 AlboGraft…Blood blushing/leaking from the surface of the graft after implantation 06/17/2013Terminated
Z-1755-2013 Class IAlboGraft Knitted with Collagen, Straight 15x06 Catalog Number: AMC1506 AlboGraft…Blood blushing/leaking from the surface of the graft after implantation 06/17/2013Terminated
Z-1754-2013 Class IAlboGraft Knitted with Collagen, Bifurcate 14x08 Catalog Number: AMC1408 AlboGraft…Blood blushing/leaking from the surface of the graft after implantation 06/17/2013Terminated
Z-1055-2013 Class IIGlow 'N Tell 20 cm Tape: 1100-00 (100 strips); 1100-50 (50 strips); 1100-20 (20 strips).…Devices were not sealed correctly during the manufacturing process, and the sterility of these products have… 03/18/2013Terminated
Z-1054-2013 Class IILeMaitre Stent Guide: 1102-00 (100 strips); 1102-50 (50 strips); 1102-20 (20 strips).…Devices were not sealed correctly during the manufacturing process, and the sterility of these products have… 03/18/2013Terminated
Z-0070-2012 LeMaitre 9F Pruitt F3 Outlying Carotid Shunt with T-port The Pruitt F3 Carotid Shunt…Extended Expiration on the outer box label 2016-05, the correct expiration date is on the tray label: 2014-05 10/04/2011Terminated
Z-0436-2011 LeMaitre VascuTape Radiopaque Tape, Glow 'N Tell 55cm Tape 20 strips Catalog Number:…Box label (Top Part). Lot and Expiration Date information were switched. 10/22/2010Terminated
Z-0435-2011 LeMaitre VascuTape Radiopaque Tape, Glow 'N Tell 30cm Tape, 100 strips Catalog Number:…Box label (Top Part). Lot and Expiration Date information were switched. 10/22/2010Terminated
Z-0434-2011 LeMaitre VascuTape Radiopaque Tape, LeMaitre Stent Guide, 100 strips Catalog Number:…Box label (Top Part). Lot and Expiration Date information were switched. 10/22/2010Terminated
Z-0433-2011 LeMaitre VascuTape Radiopaque Tape, LeMaitre Stent Guide, 20 strips Catalog Number:…Box label (Top Part). Lot and Expiration Date information were switched. 10/22/2010Terminated
Z-0165-2011 LeMaitre Vascular AnastoClip GC Vessel Closure System-Large Size Models: 4007-03 Large…Mislabeled size on external packaging: The contents section listed on the Tyvek lid labels of the Medium and… 09/22/2010Terminated
Z-0164-2011 LeMaitre Vascular AnastoClip GC Vessel Closure System-Medium Size Models: 4007-02 Medium…Mislabeled size on external packaging: The contents section listed on the Tyvek lid labels of the Medium and… 09/22/2010Terminated
Z-0008-2008 CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic…Sterility of device may be compromised due to breach in sterile barrier. 07/18/2007Terminated