Washington, DC: The Food and Drug Administration has issued a Class 1 Recall of the LeMaitre Vascular, Inc. Albograft Vascular Graft due to blood leaking from the surface of the graft after implantation. This product may cause serious adverse health consequences, including death.
Within the U.S., this device was only distributed in Pennsylvania.
This device was manufactured in April 2011, and distributed from April 2011, through June 2013.
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.
On June 19 2013, the firm sent an Urgent Field Safety Notice dated June 19, 2013, to all affected customers. Affected models are: AMC1408, AMC1506, AMC1608, AMC1809, AMC1810, AMC2010, AMC4007, AMC4008, AMC6006, AMC6007, AMC6008, ATC1526, ATC1530, ATC3016, ATC3018, ATC3024, ATC3026, Batch 56890A