Boston Scientific has updated its instructions for doctors using catheter technology to ... through blood vessels. During a cryoablation procedure, a balloon expands inside the pulmonary vein ...
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 ...
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, ...
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.
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 ...
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 ...