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
5,084
Reports (30d)
172
Active Signals
0
Open Recalls
5
What the reports describe · Claripulse analysis
Most commonly reported problems
Stuck Guidewire During PFA Procedure
guidewire, selected use, farawave, pfa procedure, catheter selected
48
reports
Stuck Guidewire During Atrial Fibrillation Ablation
guidewire, wire, farawave, farawave catheter, stuck
44
reports
Increased Pericardial Effusion Post-Ablation
pericardial effusion, farawave, pericardial, effusion, pericardiocentesis
30
reports
Patient Death Following Ablation Complications
bsc, farawave, patients, farawave catheter, pfa
26
reports
Guidewire Resistance in Catheter
selected use, guidewire, farawave, farawave catheter, catheter selected
19
reports
Cardiac Tamponade During Catheter Positioning
cardiac tamponade, tamponade, farawave, perforation, farawave catheter
18
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
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
Pulsed-field ablation of atrial fibrillation with a pentaspline catheter across National Health Service England centres
Mark T Mills, et al. · Open Heart · 2024
Procedural characteristics and acute outcomes with different pulsed field ablation systems for atrial fibrillation
Francis Jonathan Ha, et al. · Journal of Interventional Cardiac Electrophysiology · 2026
Pulsed Field Ablation–Related Hemolysis: Comparison Between Technologies
Carola Gianni, et al. · Circulation Arrhythmia and Electrophysiology · 2025
Safe and simple pulsed field ablation application using integrated 3D system for AF patients with cardiac tumors
Tetsuma Kawaji, et al. · Indian Pacing and Electrophysiology Journal · 2026
Citations indexed from PubMed.
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