LeMaitre Vascular, Inc. recalls
Every recall we track for LeMaitre Vascular, Inc. — 16 in all, from 2018–2026 — plus the complaints and injury reports the public filed about them. 1 is rated “stop using now”.
Recalls per year, by danger level
Recalls from LeMaitre Vascular, Inc. more than tripled in 2025 (6, up from 1 in 2024). 6% rated “stop using now”.
All FDA recall records for LeMaitre Vascular, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 2 | 0 | 2 |
| 2019 | 0 | 0 | 1 | 0 | 1 |
| 2020 | 0 | 1 | 0 | 0 | 1 |
| 2021 | 0 | 0 | 1 | 0 | 1 |
| 2022 | 0 | 1 | 0 | 0 | 1 |
| 2023 | 1 | 0 | 0 | 0 | 1 |
| 2024 | 0 | 1 | 0 | 0 | 1 |
| 2025 | 0 | 0 | 5 | 1 | 6 |
| 2026 (to date) | 0 | 1 | 1 | 0 | 2 |
What to do if you have a recalled LeMaitre Vascular, Inc. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All LeMaitre Vascular, Inc. recalls
14 shown- Use cautionMedical device
LeMaitre Vascular, Inc. recalls TufTex¿ Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88;
LeMaitre Vascular recalls 54 units of TufTex Over-the-Wire Embolectomy Catheter (Catalog E1651-88) due to potential balloon failure during medical procedures. Affected units distributed nationwide in specific states.
LeMaitre VascularAug 28, 2026 - Lower riskMedical device
LeMaitre Vascular, Inc. recalls Artegraft Vascular Graft; REF#: AG740;
LeMaitre Vascular recalls Artegraft Vascular Graft (REF# AG740) due to incorrect labeling causing potential confusion in product identification. This affects medical devices used in vascular procedures.
LeMaitre VascularFeb 10, 2026 - Lower riskMedical device
LeMaitre Vascular, Inc. recalls Artegraft¿ Collagen Vascular Graft; REF: AG1015;
LeMaitre Vascular recalls Artegraft Collagen Vascular Graft (REF: AG1015) due to incorrect packaging size labeling. Affected units may have wrong size labels on outer packaging.
LeMaitre VascularSep 25, 2025 - UnratedMedical device
LeMaitre Vascular, Inc. recalls Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG
LeMaitre Vascular recalls Artegraft Collagen Vascular Grafts with model numbers AG 616-1030 due to unapproved raw material from supplier. Affected items may pose health risks if used in medical procedures.
LeMaitre VascularSep 2, 2025 - Lower riskMedical device
LeMaitre Vascular, Inc. recalls Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, AG845M. The Artegraft is
LeMaitre Vascular recalls Artegraft Collagen Vascular Graft models AG630M-AG845M due to missing CE/UKCA marks and patient leaflets. Affected units lack critical safety documentation.
LeMaitre VascularAug 25, 2025 - Lower riskMedical device
LeMaitre Vascular, Inc. recalls Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56
LeMaitre Vascular recalls Pruitt Occlusion Catheters with incomplete sterile seals. Affected catalog numbers include 2103-36, 2103-46, 2103-56 and E variants. Contact for remedy details.
LeMaitre VascularApr 11, 2025 - Use cautionMedical device
LeMaitre Vascular, Inc. recalls Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies.
LeMaitre Vascular recalls sterile Syntel Silicone Thrombectomy Catheters due to risk of guide tip detachment during vascular procedures. Affected items have specific model numbers and lot codes.
LeMaitre VascularApr 17, 2024 - Stop using nowMedical device
LeMaitre Vascular, Inc. recalls The Chevalier Valvulotome is a device used to disrupt the valves of veins which are to be used as grafts in the in situ
LeMaitre Vascular recalls Chevalier Valvulotomes with burrs that could tear veins during surgery. Affected models include Catalog #40025-40035 with lot numbers starting CHV. No remedy specified in recall.
LeMaitre VascularJul 13, 2023 - Use cautionMedical device
LeMaitre Vascular, Inc. recalls TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion. It is inserted
LeMaitre Vascular recalls TufTex Embolectomy Catheters (model 3F/4F, lots XSL0097-0099) due to risk of tip breaking off if ligature slips. Affected users should contact for remedy.
LeMaitre VascularSep 30, 2022 - Lower riskMedical device
LeMaitre Vascular, Inc. recalls LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Product Usage: intended to be used to
LeMaitre Vascular recalls 35cc syringes with ISO 594 female luer lock due to potential particulate contamination in packaging foam that could affect sterile procedures.
LeMaitre VascularApr 6, 2021 - Use cautionMedical device
LeMaitre Vascular, Inc. recalls LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88, e1651-88. The LeMaitre Over
LeMaitre Vascular recalls 5F Plus Over the Wire Embolectomy Catheters with specific model numbers due to increased reports of catheters failing to deflate, which may cause tip separation during medical procedures.
LeMaitreMar 23, 2020 - Lower riskMedical device
LeMaitre Vascular, Inc. recalls The LeMaitre Aortic Occlusion Catheter is a single lumen catheter with a latex balloon, it is offered in two balloon
LeMaitre recalls aortic occlusion catheters due to incorrect size listed on packaging. This may cause improper use during medical procedures. Affected units include specific lot numbers.
LeMaitreJul 24, 2019 - Lower riskMedical device
LeMaitre Vascular, Inc. recalls LeMaitre Vascular Pruitt F3¿-S Polyurethane Outlying Carotid Shunt, Sterile Model # 2014-10
LeMaitre Vascular recalls sterile polyurethane carotid shunt model 2014-10 (lot PFP1055) due to unsealed pouches risking infection. Affected units expire March 2020.
LeMaitre VascularOct 1, 2018 - Lower riskMedical device
LeMaitre Vascular, Inc. recalls AnastoClip GC Closure System, REF# 4007-08 a closure system designed to penetrate the outer layers of tissue during the
LeMaitre Vascular recalls AnastoClip GC Closure System (REF# 4007-08) due to incorrect instructions listing unapproved uses like closing arteriotomies and veinotomies. Affected users should check if they have the product.
LeMaitre VascularJun 19, 2018
LeMaitre Vascular, Inc. recall questions
How many recalls has LeMaitre Vascular, Inc. had?
16 recalls from LeMaitre Vascular, Inc. are on record with U.S. safety agencies, from 2018–2026.
What is the most recent LeMaitre Vascular, Inc. recall?
LeMaitre Vascular, Inc. recalls TufTex¿ Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88;, dated Aug 28, 2026. Every LeMaitre Vascular, Inc. recall is listed on this page, newest first.
What should I do if I have a recalled LeMaitre Vascular, Inc. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new LeMaitre Vascular, Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.