LeMaitre Vascular recalls
9 official recalls and safety alerts involving LeMaitre Vascular since 2022-11, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with LeMaitre Vascular or the relevant agency.
- 2026-10-14
USLeMaitre Vascular, Inc. recalls TufTex¿ Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88;
Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing.
FDA · DeviceLeMaitre Vascular, Inc.US Nationwide distribution in the states of CA, FL, GA, KY, LA, NJ, OH, PA, SC.Official notice →- 2026-03-25
- US
LeMaitre Vascular, Inc. recalls Artegraft Vascular Graft; REF#: AG740;
Labeling mix-up resulting in the incorrect lot outer packaging of product.
- 2025-10-29
- US
LeMaitre Vascular, Inc. recalls Artegraft¿ Collagen Vascular Graft; REF: AG1015;
The device was incorrectly packed in the wrong size labeled outer packaging.
- 2025-10-15
- US
LeMaitre Vascular, Inc. recalls Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, AG845M. The Artegraft is intended to serve…
Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.
FDA · DeviceLeMaitre Vascular, Inc.No US distribution. International distribution to Great Britian and Switzerland.Official notice → - 2025-10-08
- US
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 715, (7) AG 730, (8)…
The bovine carotid arteries used to produce the impacted grafts from affected lots were sourced using raw material from a supplier that had not been reviewed and approved by the appropriate regulatory authority.
FDA · DeviceLeMaitre Vascular, Inc.US Nationwide distribution in the states of CA, CT, FL, GA, IL, MA, MS, NC,…Official notice → - 2025-05-21
- US
LeMaitre Vascular, Inc. recalls Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56
During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
FDA · DeviceLeMaitre Vascular, Inc.Nationwide distribution. International distribution to ARGENTINA, AUSTRALIA,…Official notice → - 2024-05-22
- US
LeMaitre Vascular, Inc. recalls Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies.
The guide tip can become damaged and result in the tip detaching.
FDA · DeviceLeMaitre Vascular, Inc.Worldwide distribution - US Nationwide and the countries of Australia, Canada,…Official notice → - 2023-09-06
- US
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 or non-reversed…
Burrs (molding flash) on the cutter may tear the harvested vien
FDA · DeviceLeMaitre Vascular, Inc.International distribution to the countries of Belgium, France, Germany, and…Official notice → - 2022-11-23
- US
LeMaitre Vascular, Inc. recalls TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion. It is inserted using a guidewire…
Three lots tied by two trainees were released without performing the required pull test. If tied with inadequate strength, the proximal ligature could slip toward the tip of the catheter and block the inflation hole,…
FDA · DeviceLeMaitre Vascular, Inc.No US distribution. Foreign distribution to United Kingdom, Germany, France,…Official notice →