Cardiac Cryoablation Device Recall - Boston Scientific Polarx System Safety Alert R2610453

Mon, 20 Apr 2026 18:16:58 +0000
Medical Devices

ANSM has recorded safety alert R2610453 following Boston Scientific's recommendation to stop use and recall of its Polarx and Polarx Fit cardiac cryoablation balloon catheters, PolarSheath steerable sheaths, and SmartFreeze cryoablation system consoles. Affected healthcare establishments have received direct notification from Boston Scientific. Users seeking further information are directed to contact Boston Scientific directly.