Boston Scientific updates catheter instructions after serious complication reports

Boston Scientific has updated the use instructions for its POLARx and POLARx FIT Cryoablation Balloon Catheters due to an unexpectedly high number of reports of atrio-esophageal fistula, a severe complication during afib ablation procedures. FDA has classified this as a Class I recall, the most serious type, indicating that the device may cause serious injury or death if used without following the updated guidelines. The revised instructions emphasize monitoring the cryoballoon's position relative to the esophagus, avoiding ablation directly over the esophagus, and utilizing temperature monitoring to minimize the risk of esophageal injury. There have been seven reported injuries and four deaths associated with these devices.

Source:

FDA. (2024, December 18). Catheter Correction: Boston Scientific Updates Use Instructions for POLARx and POLARx FIT Cryoablation Balloon Catheters due to Higher than Anticipated Number of Reports of Atrio-Esophageal Fistula. https://www.fda.gov/medical-devices/medical-device-recalls/catheter-correction-boston-scientific-updates-use-instructions-polarx-and-polarx-fit-cryoablation.