TruPulse Ablation Generator Safety with Thermocool Catheter

ANSM Drug & Device Safety Alerts

Published March 30th, 2026

Detected March 30th, 2026

Summary

ANSM issued safety notification R2608394 regarding a field safety corrective action by Biosense Webster Inc. for the TruPulse cardiac ablation generator (software version 2.7.0) when used with the Thermocool SmartTouch SF dual-energy catheter. Healthcare facilities using this equipment must review the manufacturer's safety communication dated March 30, 2026.

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What changed

Biosense Webster Inc. initiated a safety action concerning the TruPulse ablation generator software version 2.7.0 used in combination with the Thermocool SmartTouch SF dual-energy catheter. ANSM is distributing this safety notice (Reference: R2608394) to all affected healthcare establishments. The manufacturer has issued a direct communication to concerned users with specific safety instructions.

Healthcare facilities with this equipment must download and review the manufacturer's letter dated March 30, 2026. Clinical staff should assess any impact on current ablation procedures and follow the manufacturer's guidance for continued safe use or corrective measures. Contact Biosense Webster directly for questions regarding implementation of the safety action.

What to do next

Download and review the Biosense Webster Inc. safety letter from the provided PDF link
Identify all TruPulse generators running software version 2.7.0 used with Thermocool SmartTouch SF catheters at your facility
Contact Biosense Webster directly for guidance on any required corrective actions or procedure modifications

Source document (simplified)

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Information n° R2608394 destinée aux établissements de santé L'ANSM a été informée de la mise en œuvre d’une action de sécurité effectuée par la société Biosense Webster Inc.

Les utilisateurs concernés ont reçu le courrier ci-joint.

Cette action de sécurité est enregistrée à l’ANSM sous le n° R2608394. Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité.

Téléchargez le courrier de la société Biosense Webster Inc (30/03/2026)