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Five Medical Device Field Safety Notices Published April 13–17

MHRA published five Field Safety Notices (FSNs) covering the period 13–17 April 2026, affecting five distinct medical devices: Biosense Webster's cardiac irreversible electroporation catheter (09 March 2026), Dexcom's G7 iOS CGM App and Dexcom ONE+ iOS CGM App, Getinge's Stericool sterilant agent (April 2026), The Binding Site Group's EXENT Analyser, and Zimmer's Disposable Mixing Bowls. The notices are published by MHRA for information only; recipients are directed to contact the respective manufacturers directly with questions.

EP3731740A1 - Acclarent Anatomical Distance Monitoring System

The EPO published European patent application EP3731740A1 titled 'Monitoring Distance to Selected Anatomical Structures During a Procedure' filed by Acclarent, Inc. and Biosense Webster (Israel) Ltd. The A1 publication includes the international search report. The application covers medical devices for real-time anatomical distance tracking during surgical procedures under IPC classifications A61B 5/00, A61B 5/06, and A61B 1/233.

Catheter with Serially Connected Sensing Structures and Methods of Calibration and Detection

USPTO granted Patent US12594402B2 to Biosense Webster (Israel) Ltd. covering catheters with serially connected position and pressure sensing coils designed to reduce lead breakage and failure. The patent includes methods for calibration, position/pressure sensing, and detecting magnetic field interference between catheters or metal objects using dual sensor signals as an error-check mechanism.

Method and system for assisting a user in guiding a catheter during a cardial operation

The USPTO granted Patent US12594018B2 to Biosense Webster (Israel) Ltd. for a method and system assisting catheter guidance during cardiac procedures. The patent covers dynamically identifying displaced portions of a catheter distal end assembly using electrical information from electrodes, generating and warping visual representations for display. The patent contains 20 claims and was filed on May 20, 2024.

Atrial Fibrillation Trigger Detection Using Electrode Signal Correlation

USPTO published Biosense Webster (Israel) Ltd.'s patent application (US20260090756A1) for a method of detecting atrial fibrillation triggers using composite correlation scores based on signals from multiple electrodes. The invention relates to electro-anatomical mapping systems that identify suspected AF trigger locations in the heart by analyzing electrode signal correlations. Application No. 18903377 was filed October 1, 2024.

PSA Cardiac Activation Detection Method and System

The USPTO granted Patent No. US12588856B2 to Biosense Webster (Israel) Ltd. covering methods for identifying and graphically indicating cardiac tissue locations exhibiting progressively slowing activation (PSA) based on cardiac signal analysis. The patent includes 14 claims and names eight inventors including Tal Haim Bar-On and Kumaraswamy Nanthakumar.

TruPulse Ablation Generator Safety with Thermocool Catheter

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.