device recall
saveLeMaitre Vascular, Inc. device recall (Cls II)
community read0 votes
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. — Status: Ongoing
view source ↗