VARIPULSE Bi-Directional Catheter Adverse Events: FDA MAUDE Data
Biosense Webster Inc · Cardiac Ablation Catheter (Pulsed Field/PFA) · First cleared Nov 2024
Total Reports
418
Reports (30d)
41
Active Signals
1
Open Recalls
1
What the reports describe · Claripulse analysis
Most commonly reported problems
Pericardial Effusion with Catheter Error
directional, varipulse, directional catheter, varipulse catheter, varipulse directional
43
reports
Stroke After PVI + Box Ablation
stroke, varipulse, ablations, directional catheter, varipulse directional
27
reports
Phrenic Nerve Injury Post-Ablation
cardiac ablation, flow, irrigation, high, result event
3
reports
Death from Multi-Organ Failure Post-PFA
ventricular, farawave, patients, farawave catheter, study
2
reports
Catheter Leak During Flushing
selected use, farawave, farawave catheter, nav, farapulse
2
reports
Coronary Spasm During Ablation
coronary, cardiac ablation, spasm, elevation, result event
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Regulatory
FDA recalls for this device
Jan 5, 2025 · Open, Classified
Due to an observed trend of neurovascular events
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