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

ANSM Drug & Device Safety Alerts

Filed March 30th, 2026

Detected March 30th, 2026

Summary

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.

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What changed

Medtronic has initiated a field safety corrective action for the Sphere-9 dual-energy mapping and ablation catheter compatible with the Affera ablation system. ANSM recorded this safety action under reference number R2608484. The action was communicated to affected healthcare establishments via a letter dated 30/03/2026, which is available for download from the ANSM page.

Healthcare facilities that have received the Sphere-9 catheter must immediately review the Medtronic safety correspondence, identify any affected devices in their inventory, and follow the corrective actions specified by the manufacturer. Facility managers and clinical staff should coordinate to ensure affected catheters are removed from service and returned as instructed.

What to do next

Download and review the Medtronic safety letter (dated 30/03/2026) from the ANSM page
Identify all Sphere-9 catheters covered by the recall in your facility inventory
Follow Medtronic's corrective action instructions for affected devices

Source document (simplified)

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Information n° R2608484 destinée aux établissements de santé L'ANSM a été informée de la mise en œuvre d’une action de sécurité effectuée par la société Medtronic.

Les utilisateurs concernés ont reçu le courrier ci-joint.

Cette action de sécurité est enregistrée à l’ANSM sous le n° R2608484. Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité.

Téléchargez le courrier de la société Medtronic (30/03/2026)