EZ Steer NAV Adverse Events: FDA MAUDE Data
Biosense Webster Inc · Cardiac Ablation Catheter (Percutaneous) · First cleared Oct 2006 · 5 device variants grouped
Total Reports
112
Reports (30d)
0
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Cardiac Tamponade Post-Ablation Procedure
reportable, pebax, tubing, patient underwent, procedure thermocool
3
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
Doshi A, et al. · Heart rhythm O2 · 2022
Costea A, et al. · BMJ open · 2020
Schreiber T, et al. · Journal of cardiovascular electrophysiology · 2025
Rajendra A, et al. · Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2020
Pulsed Field Ablation of Persistent Atrial Fibrillation With Continuous Electrocardiographic Monitoring Follow-Up: ADVANTAGE AF Phase 2.
Reddy VY, et al. · Circulation · 2025
Citations indexed from PubMed.
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