LeMaitre Vascular, Inc.
7 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for LeMaitre Vascular, Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-10-15FDA-DeviceClass IIArtegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, AG845M. The Artegraft is intended to serve as a substitute conduit for blood where bypass or replacement of occluded or diseased arterial segments is required or to establish a conduit for hemodialysis.
Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.
- 2025-10-08FDA-DeviceClass IIArtegraft 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) AG 735, (9) AG 740, (10) AG 745, (11) AG 750, (12) AG 830, (13) AG 840, (14) AG 1015, (15) AG 1030;
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.
- 2025-05-21FDA-DeviceClass IIPruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09.
During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
- 2025-05-21FDA-DeviceClass IIPruitt 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).
- 2025-05-21FDA-DeviceClass IITufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651-38, 1651-44, 1651-48, 1651-58, 1651-64, 1651-68, 1651-78, 1651-84, 1651-88, E1651-34, E1651-38, E1651-44, E1651-48, E1651-64, E1651-68, E1651-78, E1651-84, E1651-88, 1651-44J, 1651-48J, 1651-84J, 1651-88J.
During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
- 2024-05-22FDA-DeviceClass IISyntel 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.
- 2023-09-06FDA-DeviceClass IIThe 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 bypass procedure. The Chevalier Valvulotome consists of a 70 cm stainless steel shaft with two tips: 1) the cutting tip is shaped like an inverted tulip with four teeth at its base. This tip is designed to cut the vein valve cusps. 2) the other tip is atraumatic and used to test the patency and the course of the vein before the valvulotomy. The Chevalier Valv
Burrs (molding flash) on the cutter may tear the harvested vien
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