Boston Scientific revised Polarx cryoablation catheter guidelines after 7 esophageal injuries and 4 deaths were reported. Updated instructions focus on monitoring catheter position and avoiding ...
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.
No hardware is being removed from use—instead, the company’s effort focuses on updating the instructions for the POLARx procedure, following a higher-than-anticipated number of reports ...