Field Safety Notice: Velox CD Vascular Closure Device lot #TT039762

woensdag 16 december 2015 12:00

Vascular closure implants were observed to deploy incompletely, with intraluminal material (e.g. Footplate) delivered without proper tethering to extraluminal material (e.g. Plug). In cases observed, no evidence of arterial occlusion was detected and hemostasis was achieved through application of manual compression. If the potential exists for either vessel occlusion or arterial bleeding.