LeMaitre Vascular, Inc.
9 federal recalls on file, showing the 4 from the last 12 months. 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 IICheck LeMaitre Vascular Artegraft Graft packaging
LeMaitre Vascular is recalling one unit of Artegraft Vascular Graft (Model AG740) distributed in Illinois due to a labeling mix-up on the outer packaging. The product box was labeled with an incorrect lot number, which could cause confusion during clinical use. No injuries have been reported.
- 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.
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