LeMaitre Vascular, Inc. Recalls
8 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.
Medical Device Recalls (8)
- Class II
February 10, 2026
Artegraft Vascular Graft; REF#: AG740;
Labeling mix-up resulting in the incorrect lot outer packaging of product.
- Class II
September 25, 2025
Artegraft¿ Collagen Vascular Graft; REF: AG1015;
The device was incorrectly packed in the wrong size labeled outer packaging.
- Class II
September 2, 2025
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) AG 735, (9) AG 740, (10) AG 745, (11) AG 750, (12) AG 830, (1
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.
- Class II
August 25, 2025
Artegraft 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 repla
Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.
- Class II
April 11, 2025
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).
- Class II
April 11, 2025
Pruitt 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).
- Class II
April 11, 2025
TufTex 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, E16
During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
- Class II
April 17, 2024
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.
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