Sphere-9 Dual-Energy Mapping and Ablation Catheter Safety Recall

Mon, 30 Mar 2026 18:21:29 +0000
Medical Devices

ANSM has recorded a field safety corrective action by Medtronic for the Sphere-9 dual-energy mapping and ablation catheter system (combining electroporation and radiofrequency) under reference R2608484. Healthcare establishments must review the Medtronic safety letter and take appropriate action regarding affected devices.