On Wednesday, Boston Scientific Corporation (NYSE:BSX) revised the usage guidelines for its Polarx and Polarx FIT cryoablation balloon catheters following reports of serious injuries, including seven ...
The FDA is elevating a recall from Boston Scientific covering its cryoablation balloon catheters for the treatment of atrial fibrillation. No hardware is being removed from use—instead, the company’s ...
Boston Scientific (NYSE:BSX) has issued a correction recall for its POLARx and POLARx FIT cryoablation balloon catheters over concerns that they may cause serious esophageal injuries or even death.