Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list LeMaitre Vascular with 71 device recalls, 35 510(k) clearances and 1 warning letter. The most recent is a device recall dated Aug 28, 2026: TufTex¿ Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88;.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Aug 28, 2026 | TufTex¿ Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88;Class II · Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components fai | Device recalls |
| Feb 10, 2026 | Artegraft Vascular Graft; REF#: AG740;Class II · Labeling mix-up resulting in the incorrect lot outer packaging of product. | Device recalls |
| Sep 25, 2025 | Artegraft¿ Collagen Vascular Graft; REF: AG1015;Class II · The device was incorrectly packed in the wrong size labeled outer packaging. | Device recalls |
| Sep 2, 2025 | 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) AClass II · The bovine carotid arteries used to produce the impacted grafts from affected lots were sourced using raw material from | Device recalls |
| Aug 25, 2025 | Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, AG845M. The Artegraft is intended to sClass II · Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card | Device recalls |
| Aug 11, 2025 | Warning letter: Sterility assurance, Process validation, Environmental monitoringCDRH | Warning letters |
| Apr 11, 2025 | Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56Class II · During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier). | Device recalls |
| Apr 11, 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, 16Class II · During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier). | Device recalls |
| Apr 11, 2025 | Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09.Class II · During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier). | Device recalls |
| Mar 31, 2022 | PhasTIPPK212894 · DWQ | 510(k) clearances |
| Feb 13, 2020 | XenoSure Biologic PatchK190882 · PSQ | 510(k) clearances |
| Oct 30, 2019 | EZE SIT ValvulotomeK190267 · MGZ | 510(k) clearances |
| Jun 13, 2019 | XenoSure Dura Biologic PatchK183513 · GXQ | 510(k) clearances |
| Nov 16, 2018 | Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 FrK182916 · MJN | 510(k) clearances |
| Mar 8, 2018 | AnastoClip GC Closure SystemK173323 · FZP | 510(k) clearances |
| Jan 21, 2016 | Pruitt F3-S Polyurethane Carotid ShuntK152833 · MJN | 510(k) clearances |
| Aug 27, 2015 | Pruitt F3-S Carotid ShuntK143454 · MJN | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
