FDA-Device2025-10-15Class II
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.
Hazard
Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.
Sold states
No US distribution. International distribution to Great Britian and Switzerland.
Affected count
10 units
Manufactured in
206 N Center Dr, North Brunswick, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0072-2026Want us to check the next one for you?
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