LeMaitre Vascular, Inc.
FDA Regulatory Profile
LeMaitre Vascular, Inc. appears in FDA public data with 70 recalls — including 18 Class I (most serious) —, 35 510(k) clearances, 22 FDA inspections, and 2 compliance actions on record. Its most recent recall (Z-1574-2026, Class II) was initiated on February 10, 2026. Its most recent 510(k) clearance was granted on March 31, 2022.
Summary
- Total Recalls
- 70 (18 Class I)
- 510(k) Clearances
- 35
- Inspections
- 22
- Compliance Actions
- 2
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1574-2026 | Class II | Artegraft Vascular Graft; REF#: AG740; | February 10, 2026 |
| Z-0289-2026 | Class II | Artegraft¿ Collagen Vascular Graft; REF: AG1015; | September 25, 2025 |
| Z-0034-2026 | Class II | Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, ( | September 2, 2025 |
| Z-0072-2026 | Class II | Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, AG84 | August 25, 2025 |
| Z-1751-2025 | Class II | Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56 | April 11, 2025 |
| Z-1750-2025 | Class II | TufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651-38, 1651-44, 1651-48, | April 11, 2025 |
| Z-1752-2025 | Class II | Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09. | April 11, 2025 |
| Z-1824-2024 | Class II | Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral veno | April 17, 2024 |
| Z-2468-2023 | Class II | The Chevalier Valvulotome is a device used to disrupt the valves of veins which are to be used as gr | July 13, 2023 |
| Z-0228-2023 | Class II | TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extr | September 30, 2022 |
| Z-1529-2021 | Class II | LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Product Usage: intended t | April 6, 2021 |
| Z-1567-2020 | Class I | LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88, e1651-88 | March 23, 2020 |
| Z-2448-2019 | Class II | The LeMaitre Aortic Occlusion Catheter is a single lumen catheter with a latex balloon, it is offere | July 24, 2019 |
| Z-0473-2019 | Class II | LeMaitre Vascular Pruitt F3¿-S Polyurethane Outlying Carotid Shunt, Sterile Model # 2014-10 | October 1, 2018 |
| Z-3042-2018 | Class II | AnastoClip GC Closure System, REF# 4007-08 a closure system designed to penetrate the outer layers o | June 19, 2018 |
| Z-1446-2017 | Class II | LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter (eIFU) REF# e2401-50 | February 7, 2017 |
| Z-1448-2017 | Class II | LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-51 | February 7, 2017 |
| Z-1442-2017 | Class II | LeMaitre Vascular Reddick Cholangiogram Catheter (eIFU) REF# e2400-50 | February 7, 2017 |
| Z-1447-2017 | Class II | LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter (paper IFU) REF# 2401-50 | February 7, 2017 |
| Z-1449-2017 | Class II | LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (paper IFU) REF# 2401-51 | February 7, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K212894 | PhasTIPP | March 31, 2022 |
| K190882 | XenoSure Biologic Patch | February 13, 2020 |
| K190267 | EZE SIT Valvulotome | October 30, 2019 |
| K183513 | XenoSure Dura Biologic Patch | June 13, 2019 |
| K182916 | Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr | November 16, 2018 |
| K173323 | AnastoClip GC Closure System | March 8, 2018 |
| K152833 | Pruitt F3-S Polyurethane Carotid Shunt | January 21, 2016 |
| K143454 | Pruitt F3-S Carotid Shunt | August 27, 2015 |
| K142660 | Antegrade LeMills Valvulotome | October 17, 2014 |
| K140042 | 1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME | April 10, 2014 |
| K133026 | UNBALLOON NON-OCCLUSION MODELING CATHETER | December 31, 2013 |
| K132022 | LEMAITRE 8F OCCLUSION CATHETER | November 6, 2013 |
| K132047 | LEMILLS VALVULOTOME | November 5, 2013 |
| K132190 | EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOME | August 5, 2013 |
| K130016 | LIFESPAN EPTFE VASCULAR GRAFT | February 5, 2013 |
| K123531 | UNBALLOON NON-OCCLUSIVE MODELING CATHETER | December 14, 2012 |
| K121415 | MOLLRING MULTITASC | September 5, 2012 |
| K121839 | UNBALLOON NON-OCCLUSIVE MODELING CATHETER | August 8, 2012 |
| K110891 | THE UNBALLOON NON-OCCLUSIVE CATHETER; THE UNBALLOON NON-OCCLUSIVE MODELING CATHETER | September 13, 2011 |
| K111884 | OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOME | July 29, 2011 |