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LeMaitre Vascular, Inc. FDA Recalls
11 recalls on file across devices, 0 of them Class I and 10 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Artegraft Vascular Graft; REF#: AG740;Class IIFeb 10, 2026Labeling mix-up resulting in the incorrect lot outer packagi |
| Artegraft¿ Collagen Vascular Graft; REF: AG1015;Class IISep 25, 2025The device was incorrectly packed in the wrong size labeled |
| Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG 71Class IISep 2, 2025The bovine carotid arteries used to produce the impacted gra |
| Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, AG845M. The ArtegrClass IIAug 25, 2025Devices were distributed with incorrect label without CE and |
| TufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651-38, 1651-44, 1651-48, 1651-58, 1651-64, 1Class IIApr 11, 2025During internal product testing, it was observed that some p |
| Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56Class IIApr 11, 2025During internal product testing, it was observed that some p |
| Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09.Class IIApr 11, 2025During internal product testing, it was observed that some p |
| Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies.Class IIApr 17, 2024The guide tip can become damaged and result in the tip detac |
| 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 IIJul 13, 2023Burrs (molding flash) on the cutter may tear the harvested v |
| TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion. It is inserteClass IISep 30, 2022Three lots tied by two trainees were released without perfor |
| LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Product Usage: intended to be used to perfuseClass IIApr 6, 2021The firm received a complaint regarding particulate found in |