TruPulse Ablation Generator Safety with Thermocool Catheter

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

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.