FDA recall record · openFDA

LeMaitre Vascular, Inc.

9 FDA recalls on record (2023–2026) — 9 device. 9 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier). 3

The guide tip can become damaged and result in the tip detaching. 1

Labeling mix-up resulting in the incorrect lot outer packaging of product. 1

The bovine carotid arteries used to produce the impacted grafts from affected lots were sourced using raw material from 1

Burrs (molding flash) on the cutter may tear the harvested vien 1

Recalls

Artegraft Vascular Graft; REF#: AG740; Class II 2026-02-10 Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG 71 Class II 2025-09-02 Artegraft¿ Collagen Vascular Graft; REF: AG1015; Class II 2025-09-25 Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56 Class II 2025-04-11 TufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651-38, 1651-44, 1651-48, 1651-58, 1651-64, 1 Class II 2025-04-11 Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, AG845M. The Artegr Class II 2025-08-25 Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09. Class II 2025-04-11 Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies. Class II 2024-04-17 The Chevalier Valvulotome is a device used to disrupt the valves of veins which are to be used as grafts in the in situ Class II 2023-07-13

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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