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.
- 2026-03-25FDA-DeviceClass IIArtegraft Vascular Graft; REF#: AG740;
Labeling mix-up resulting in the incorrect lot outer packaging of product.
- 2025-10-29FDA-DeviceClass IIArtegraft¿ Collagen Vascular Graft; REF: AG1015;
The device was incorrectly packed in the wrong size labeled outer packaging.
- 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).
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