The Albograft Vascular Graft was recalled due to blood leaking from the surface of the graft after implantation. This device was manufactured in April 2011, and distributed from April 2011, through June 2013. Within the U.S., this device was distributed only in Pennsylvania.
The Albograft Vascular Graft is made of synthetic material. It is designed to replace or repair a damaged artery with an abnormal enlargement (aneurysm) or a blockage (occlusion) caused by a disease.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
See the FDA Recall