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 ...

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 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 ...

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

Devices already in inventory can be used with the updated instructions by doctors. Patients already treated don’t need to do anything. Boston Scientific has updated its instructions for doctors ...

STEMart, a US-based provider of comprehensive services for all phases of medical device development, announces the expansion of its medical device testing capabilities and introduces Balloon Catheter ...

This is a prospective randomized single-blind study. The study complies with the Declaration of Helsinki. The hospital ethics committee approved the study and patients gave informed consent on ...