Recall Z-0072-2026— LeMaitre Vascular, Inc.
Class II · Ongoing
Class II FDA medical device recall by LeMaitre Vascular, Inc., initiated 2025-08-25. FDA's recall record names no specific 510(k) clearance for this event. Product: 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 replacement of occluded or diseased arterial segments is required or to establish a conduit for hemodialysis.. Reason: Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card..
- Recalling firm
- LeMaitre Vascular, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-08-25
- Firm location
- North Brunswick, NJ, United States
Product description
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 replacement of occluded or diseased arterial segments is required or to establish a conduit for hemodialysis.
Reason for recall
Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.
Data sourced from openFDA. This site is unofficial and independent of the FDA.