Several models of Albograft Vascular Grafts used to replace or repair a damaged artery with an abnormal enlargement (aneurysm) or blockage (occlusion) caused by disease are being recalled because of a potentially deadly defect that can allow blood to leak from the surface of the graft after implantation.
LeMaitre Vascular, Inc., ordered the recall on several models, which were distributed in Pennsylvania from April 2011 through June 2013. The recall is categorized as a Class 1, which is the most serious type of recall and involves situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
LeMaitre Vascular sent letters to customers who received the Vascular Grafts informing them of the problem and the action to be taken, which instructed them to identify and return the affected devices. The notice followed several device failure reports submitted to the Food and Drug Administration (FDA).
Customers or consumers can report any adverse events or quality issues with medical devices to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.