VARIPULSE Bi-Directional Catheter Adverse Events: FDA MAUDE Data
Biosense Webster Inc · Cardiac Ablation Catheter (Pulsed Field/PFA) · First cleared Nov 2024
Total Reports
519
Reports (30d)
49
Active Signals
1
Open Recalls
1
What the reports describe · Claripulse analysis
Most commonly reported problems
Cerebral Infarction Post-Ablation
varipulse, ablations, directional catheter, varipulse catheter, varipulse directional
58
reports
Pericardial Effusion with Blood Pressure Drop
pericardial effusion, farawave, pericardial, effusion, farawave catheter
12
reports
Coronary Spasm with ST Elevation
varipulse, spasm, event cardiac, elevation, result event
4
reports
Literature Batch: Acute Kidney Injury
farawave, acute, patients, farawave catheter, study
1
reports
Vagal Response Inducing Bradycardia
unknown patient, pacing, vagal response, presented, 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
Evidence
Related research
AI-Assisted 3D Intracardiac Echocardiography for Pulsed Field Ablation of Atrial Fibrillation Using a Novel Variable Loop Circular Catheter: A Multicenter Evaluation
Antonio Dello Russo, et al. · Journal of Clinical Medicine · 2025
When low is not low enough: zero-fluoroscopy atrial fibrillation ablation using the VARIPULSE™ pulsed field system—a prospective single-center study
Edouard Siméon, et al. · Journal of Interventional Cardiac Electrophysiology · 2025
Mitigating Iatrogenic Air Entrainment During Pulsed Field Ablation ― A Comparative Study of a Novel Submerged-Entry Technique Using the VARIPULSE<sup>TM</sup> System ―
Ting‐Yung Chang, et al. · Circulation Reports · 2026
Left atrial substrate modification in addition to pulmonary vein isolation using a novel circular variable loop pulsed field ablation catheter
Alessandro Parlato, et al. · European Heart Journal - Case Reports · 2025
Borlich M, et al. · Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2025
Citations indexed from PubMed.
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