Boston Scientific has updated the instructions for its Polarx and Polarx FIT cryoablation balloon catheters, the Food and Drug Administration said Wednesday. The update followed a higher than ...

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.

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 recall involves updating instructions for use rather than removing the device, POLARx Cryoablation Balloon Catheters, from where they are used or sold, the FDA said. The company meanwhile is ...

Boston Scientific has issued a recall for its POLARx Cryoablation Balloon Catheters after four deaths and seven reported injuries linked to astrio-esophageal fistulas, a severe complication during ...

Get Monthly Picks of Market's Fastest Movers Boston Scientific is updating use instructions for POLARx Cryoablation Balloon Catheters due to a higher than anticipated number of reports of ...

During a cryoablation procedure, a balloon expands inside the pulmonary ... Seven reports of injuries and four fatalities are linked to the catheters. The FDA has classified the instruction ...

Boston Scientific to acquire Bolt Medical for $600 million upfront plus milestones. Bolt's IVL platform addresses coronary ...

A 7-Fr 6-mm-tip CRYO catheter (Freezor Xtra, Cryocath Technologies) was used. The procedure was performed under local anesthesia (2% lignocaine) without sedation. Cryomapping was carried out at ...