FARASTAR Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · Cardiac Ablation Catheter (Pulsed Field/PFA) · First cleared Jan 2024 · 49 device variants grouped
Total Reports
137
Reports (30d)
7
Active Signals
4
Open Recalls
5
What the reports describe · Claripulse analysis
Most commonly reported problems
Generator Voltage Failure During PFA
selected use, generator, pfa procedure, error, cable
11
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
Jun 11, 2026 · Open, Classified
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
Jun 11, 2026 · Open, Classified
Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.
Jun 11, 2026 · Open, Classified
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
Jun 11, 2026 · Open, Classified
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
Jun 25, 2025 · Open, Classified
The potentially impacted units were manufactured using specific equipment that may have caused cracks in the electrode bands on the catheter's distal end.
Evidence
Related research
Pulmonary vein narrowing after pulsed field versus thermal ablation.
Mansour M, 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 pentaspline pulsed field ablation system: one-year outcomes of the FARADISE registry.
Boersma LVA, 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 · 2025
Long-term outcomes of the pentaspline pulsed-field ablation catheter for the treatment of paroxysmal atrial fibrillation: results of the prospective, multicentre FARA-Freedom Study.
Metzner A, 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
EUropean real-world outcomes with Pulsed field ablatiOn in patients with symptomatic atRIAl fibrillation: lessons from the multi-centre EU-PORIA registry.
Schmidt B, 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 · 2023
Pulsed-Field Ablation for Persistent Atrial Fibrillation in EU-PORIA Registry.
Hirokami J, et al. · Journal of cardiovascular electrophysiology · 2025
Citations indexed from PubMed.
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