FARAWAVE Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · Cardiac Ablation Catheter (Pulsed Field/PFA) · First cleared Jan 2024 · 9 device variants grouped
Total Reports
4,906
Reports (30d)
168
Active Signals
1
Open Recalls
5
What the reports describe · Claripulse analysis
Most commonly reported problems
Guidewire Stuck During Use
selected use, guidewire, farawave, selected, farawave catheter
117
reports
Pericardial Effusion with Blood Pressure Drop
pericardial effusion, farawave, pericardial, effusion, farawave catheter
99
reports
Guidewire Stuck in Catheter Lumen
selected use, guidewire, farawave, pfa procedure, farawave catheter
54
reports
Literature Batch: Acute Kidney Injury
farawave, acute, patients, farawave catheter, study
14
reports
Stroke Following Procedure
post procedure, stroke, farawave, selected, farawave catheter
12
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
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
First clinical experience using a pentaspline pulse field ablation catheter with integrated electroanatomic 3-dimensional mapping for pulmonary vein isolation
Gianfranco Mitacchione, et al. · Heart Rhythm · 2025
Controversy: pulsed field ablation is the standard technique for all the candidates for atrial fibrillation ablation
Luigi Di Biase, et al. · EP Europace · 2025
Pulsed-field ablation-based pulmonary vein isolation: acute safety, efficacy and short-term follow-up in a multi-center real world scenario
Marc D. Lemoine, et al. · Clinical Research in Cardiology · 2022
Pulsed field ablation for atrial fibrillation in a patient with cor triatriatum sinister using a single-shot mapping-integrated catheter
Panteleimon E. Papakonstantinou, et al. · Heart Rhythm O2 · 2026
Pulsed Field Ablation–Related Hemolysis: Comparison Between Technologies
Carola Gianni, et al. · Circulation Arrhythmia and Electrophysiology · 2025
Citations indexed from PubMed.
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