LeMaitre Vascular, Inc.

FDA Regulatory Profile

Summary

Total Recalls
69 (18 Class I)
510(k) Clearances
35
Inspections
22
Compliance Actions
2

Recent Recalls

NumberClassProductDate
Z-0289-2026Class IIArtegraft¿ Collagen Vascular Graft; REF: AG1015;September 25, 2025
Z-0034-2026Class IIArtegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (September 2, 2025
Z-0072-2026Class IIArtegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, AG84August 25, 2025
Z-1751-2025Class IIPruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56April 11, 2025
Z-1750-2025Class IITufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651-38, 1651-44, 1651-48, April 11, 2025
Z-1752-2025Class IIPruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09.April 11, 2025
Z-1824-2024Class IISyntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venoApril 17, 2024
Z-2468-2023Class IIThe Chevalier Valvulotome is a device used to disrupt the valves of veins which are to be used as grJuly 13, 2023
Z-0228-2023Class IITufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrSeptember 30, 2022
Z-1529-2021Class IILeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Product Usage: intended tApril 6, 2021
Z-1567-2020Class ILeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88, e1651-88March 23, 2020
Z-2448-2019Class IIThe LeMaitre Aortic Occlusion Catheter is a single lumen catheter with a latex balloon, it is offereJuly 24, 2019
Z-0473-2019Class IILeMaitre Vascular Pruitt F3¿-S Polyurethane Outlying Carotid Shunt, Sterile Model # 2014-10October 1, 2018
Z-3042-2018Class IIAnastoClip GC Closure System, REF# 4007-08 a closure system designed to penetrate the outer layers oJune 19, 2018
Z-1442-2017Class IILeMaitre Vascular Reddick Cholangiogram Catheter (eIFU) REF# e2400-50February 7, 2017
Z-1444-2017Class IILeMaitre Vascular Reddick Cholangiogram Catheter with introducer(eIFU) REF # e2400-52February 7, 2017
Z-1448-2017Class IILeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-51February 7, 2017
Z-1447-2017Class IILeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter (paper IFU) REF# 2401-50February 7, 2017
Z-1452-2017Class IILeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-53February 7, 2017
Z-1451-2017Class IILeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (paper IFU) REF# 2401-52February 7, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K212894PhasTIPPMarch 31, 2022
K190882XenoSure Biologic PatchFebruary 13, 2020
K190267EZE SIT ValvulotomeOctober 30, 2019
K183513XenoSure Dura Biologic PatchJune 13, 2019
K182916Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 FrNovember 16, 2018
K173323AnastoClip GC Closure SystemMarch 8, 2018
K152833Pruitt F3-S Polyurethane Carotid ShuntJanuary 21, 2016
K143454Pruitt F3-S Carotid ShuntAugust 27, 2015
K142660Antegrade LeMills ValvulotomeOctober 17, 2014
K1400421.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOMEApril 10, 2014
K133026UNBALLOON NON-OCCLUSION MODELING CATHETERDecember 31, 2013
K132022LEMAITRE 8F OCCLUSION CATHETERNovember 6, 2013
K132047LEMILLS VALVULOTOMENovember 5, 2013
K132190EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOMEAugust 5, 2013
K130016LIFESPAN EPTFE VASCULAR GRAFTFebruary 5, 2013
K123531UNBALLOON NON-OCCLUSIVE MODELING CATHETERDecember 14, 2012
K121415MOLLRING MULTITASCSeptember 5, 2012
K121839UNBALLOON NON-OCCLUSIVE MODELING CATHETERAugust 8, 2012
K110891THE UNBALLOON NON-OCCLUSIVE CATHETER; THE UNBALLOON NON-OCCLUSIVE MODELING CATHETERSeptember 13, 2011
K111884OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOMEJuly 29, 2011