The United States Food and Drug Administration (FDA) has issued a medical device safety alert concerning Albograft Vascular Graft [Model no.: AMC1408, AMC1506, AMC1608, AMC1809, AMC1810, AMC2010, AMC4007, AMC4008, AMC6006, AMC6007, AMC6008, ATC1526, ATC1530, ATC3016, ATC3018, ATC3024, ATC3026; Batch no.: 56890A], manufactured by LeMaitre Vascular, Inc . The affected devices were manufactured in April 2011, and distributed from April 2011 through June 2013.
According to the FDA, the Albograft Vascular Graft is designed to replace or repair a damaged artery with an abnormal enlargement (aneurysm) or a blockage (occlusion) caused by a disease. This product was recalled due to blood leaking from the surface of the graft after implantation. This product may cause serious adverse health consequences, including death.
For details, please visit the following FDA websites:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm362217.htm
http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm362204.htm
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 25 July 2013