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

4,178

Reports (30d)

284

Active Signals

Open Recalls

Monthly Report Volume

Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

Guidewire Stuck in Catheter Tip

selected use, guidewire, patient complications, selected, farawave catheter

314

reports

Pericardial Effusion After PFA Procedure

pericardial effusion, tamponade, pericardial, farawave catheter, pericardiocentesis

reports

Hemolysis Following PFA Procedure

lesions, posterior wall, selected, pfa procedure, patients

reports

Patient Death Post-PFA with Unknown Cause

using farawave, pfa procedure, patients, farawave catheter, access

reports

Flush Port Obstruction with Glue

opened, appearance, glue, flush, flushing

reports

ST Segment Elevation and Hypotension

air, coronary, pfa procedure, farawave catheter, elevation

reports

Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.

Detection

Active safety signals

Disproportionate reportinghighVolume spikehighIncreasing trendcriticalDisproportionate reportinghighDisproportionate reportinghighDisproportionate reportinghigh

Regulatory

FDA recalls for this device

Class II

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

Pulsed-field ablation of atrial fibrillation with a pentaspline catheter across National Health Service England centres

Mark T Mills, et al. · Open Heart · 2024

Fluoroscopy-Free Pulsed Field Ablation for Atrial Fibrillation: A Systematic Review of Procedural Feasibility and Safety.

Sawalha K, et al. · 2026

Electrogram-guided pulsed field ablation for persistent atrial fibrillation: A prospective cohort study.

Li K, et al. · 2026

Controversy: pulsed field ablation is the standard technique for all the candidates for atrial fibrillation ablation.

Di Biase L, et al. · 2025

Safety of extensive pulsed field ablation for atrial fibrillation in a patient with left ventricular assist device: a case report.

Ouali S, et al. · 2025

Citations indexed from PubMed.

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Understanding this data

What FDA MAUDE data does and does not tell you

How these reports are filed, why raw counts mislead, and the limits to know before drawing conclusions.

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How a safety signal is detected

What the "Active Signals" count above means and the methods that separate a real signal from noise.

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Disclaimer: This system analyzes publicly available FDA MAUDE data. It does NOT provide medical advice. MAUDE data is de-identified. Do not attempt re-identification. Report counts may differ from the FDA's MAUDE search due to processing cadence and deduplication. Data is updated weekly.