Volt PFA Sensor Enabled Adverse Events: FDA MAUDE Data
ABBOTT (ST. JUDE MEDICAL) · Cardiac Ablation Catheter (Pulsed Field/PFA) · First cleared Dec 2025
Total Reports
105
Reports (30d)
13
Active Signals
2
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Guidewire Fracture with Cardiac Tamponade
fibrillation, atrial, atrial fibrillation, farawave, pfa
20
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Evidence
Related research
Initial clinical experience with the balloon-in-basket pulsed field ablation system: acute results of the VOLT CE mark feasibility study.
Sanders P, et al. · Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2024
Real‐World Experience With the Balloon‐in‐Basket Pulsed Field Ablation System for Pulmonary Vein Isolation and Ablation of Extra‐Pulmonary Vein Sites
Henri Xhakupi, et al. · Journal of Cardiovascular Electrophysiology · 2026
Pulmonary vein isolation durability in a randomized trial comparing fluoroscopy-only vs. electroanatomic mapping strategies for pulmonary vein isolation with balloon-in-basket pulsed-field ablation
Daniel Rodríguez Muñoz, et al. · EP Europace · 2026
Safety and Effectiveness of a Novel Dual-Energy Radiofrequency/Pulsed Field Ablation Catheter: 12 Month Results of the FlexPulse Study
Ayman Ali Hussein, et al. · EP Europace · 2026
Bioinspired balloon catheter integrated with stretchable “flounder” electrodes under high voltage for uniform pulsed field ablation
Xuejing Shen, et al. · Science Advances · 2024
Citations indexed from PubMed.
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