The U.S. Food and Drug Administration (FDA) issued a Class 1 Recall of Albograft Vascular Graft, made by LeMaitre Vascular, Inc., due to the fact that after implantation, blood would leak from the surface of the graft.
Class 1 recalls are the most serious type of recall, and involve situations that relate to the possibility of serious adverse health consequences or death.
As a result, the Albograft Vascular Graft may cause serious adverse health effects, such as death. In the United States, only Pennsylvania distributed the defective device.
On June 19, 2013, there was an Urgent Field Safety Notice, which was sent to all affected customers.
This device was manufactured in April 2011, and distribution occurred from April 2011 through June 2013. The Albograft Vascular Graft is made of synthetic material, designed to replace or repair a damaged artery suffering from an aneurysm, or abnormal enlargement, or a blockage, or occlusion, caused by a disease.
The affected models are: AMC1408, AMC1506, AMC1809, AMC1810, AMC2010, AMC4007, AMC4008, AMC6006, AMC6007, AMC6008, ATC1526, ATC3016, ATC3018, ATC3024, ATC3026, Batch 56890A.
For more information, contact a Gacovino Lake attorney at 1-800-246-HURT (4878).