Federal Regulators Issue Tissue Erosion Warning on St. Jude’s Amplatzer Cardiac Implant The safety warning has been issued on St. Jude Medical’s Amplatzer ASO, a cardiac medical device used to close atrial septal defects. The heart device can cause cardiac tissue erosion. To date, the U.S. Food and Drug Administration (FDA) has … Continue reading ?
Oct. 23, 2013 - NewsInferno
STJ’s Amplatzer cardiac implant device hit with FDA safety alert St. Jude Medical (STJ) received an FDA safety alert for its Amplatzer ASO, a minimally-invasive implantable cardiac device used to treat atrial septal defect. The problem? In one to three of every 1,000 patients, “ tissue surrounding the Amplatzer ASO can break down (erode) and result in life-threatening emergencies that require immediate surgery.” More on the […]
Oct. 18, 2013 - MedCity News