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
103
Reports (30d)
7
Active Signals
2
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Signal Loss from Generator During Procedure
adverse, current, generator, pfa procedure, cable
12
reports
Increased Pericardial Effusion During Ablation
pericardial effusion, farawave, pericardial, effusion, pericardiocentesis
6
reports
Loose Cable Connector During Procedure
completed pulsed, cardiac ablation, case completed, array, cable
4
reports
Cerebral Infarction Post-Ablation
varipulse, ablations, directional catheter, varipulse catheter, varipulse directional
1
reports
Stroke Following Farawave Catheter Use
selected use, stroke, farawave, selected, thrombus
1
reports
Visible Water Marks on Catheter
farawave, farawave nav, farawave catheter, catheter selected, nav
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
Evidence
Related research
Initial clinical experience with the balloon-in-basket pulsed field ablation system: acute results of the VOLT CE mark feasibility study
Prashanthan Sanders, et al. · EP Europace · 2024
Bioinspired balloon catheter integrated with stretchable “flounder” electrodes under high voltage for uniform pulsed field ablation
Xuejing Shen, et al. · Science Advances · 2024
Catheter ablation using pulsed‐field energy: Advantages and limitations compared with conventional energy
Kenji Kuroki, et al. · Journal of Arrhythmia · 2025
Citations indexed from PubMed.
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