The HeartWare Ventricular Assist Device (HVAD) has been the subject of a series of recalls. All HeartWare systems currently in use are being recalled. Recalled systems were manufactured and distributed between January 2008 and March 2015. HeartWare will replace all defective controllers by the end of June 2016. Click title to continue reading...
The FDA, in partnership with international regulatory and law enforcement agencies, took action recently against more than 1,050 websites that illegally sell potentially dangerous, unapproved prescription medicines and medical devices to consumers. These actions include the issuance of regulatory warnings to the operators of offending websites and seizure of illegal medicines and medical devices worldwide. Click title to continue reading...
A June 19, 2015 Centers for Disease Control and Prevention report found that congenital heart defects occur in approximately eight of every 1,000 live births. Critical congenital heart defects (CCHD) occur in approximately two of every 1,000 live births. CCHD are defined as those requiring surgery or catheterization before the child turns one. In the absence of early detection, infants with CCHD are at risk for serious complications or death within the first few days or weeks of life. Click title to continue reading...