FDA Issues Warning for Atrial Septal Defect Treatment Device
The FDA issued a warning for the St. Jude Amplatzer Atrial Septal Occluder, a device used to treat children and adults with an atrial septal defect, due to the potential for tissue erosion. According to the FDA, “in very rare instances, tissue surrounding the Amplatzer ASO can break down (erode) and result in life-threatening emergencies that require immediate surgery.” The warning urges health care professionals to read the updated instructions carefully and educate patients about symptoms of erosion so they can be treated immediately. Read the full FDA safety alert.
< Back to Listings