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

Boston Scientific initiated a stop-use recommendation and market withdrawal for its Polarx, Polarx Fit, PolarSheath, and SmartFreeze cardiac cryoablation devices, recorded by ANSM as safety alert R2610453. The action follows identification of a safety concern prompting the firm to notify affected users directly.\n\nFrench healthcare establishments using these cryoablation systems should locate and review the Boston Scientific user communication dated 20/04/2026, verify whether any affected devices are in use or in stock, and contact Boston Scientific directly for further guidance. This recall affects cardiac cryoablation procedures and procurement inventory at rhythmology centres.