VARIPULSE Bi-Directional Catheter Adverse Events: FDA MAUDE Data

Biosense Webster Inc · Cardiac Ablation Catheter (Pulsed Field/PFA) · First cleared Nov 2024

Total Reports

335

Reports (30d)

Active Signals

Open Recalls

Monthly Report Volume

Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

Cerebrovascular Accident Post-Ablation

stroke, varipulse, directional catheter, mri, varipulse catheter

reports

Cardiac Tamponade Requiring Pericardiocentesis

varipulse, directional catheter, pericardial, varipulse directional, pericardiocentesis

reports

Guidewire Stuck in Catheter Tip

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

reports

Generator Error Causing Procedure Delay

current, generator, pfa procedure, error, cable

reports

Pericardial Effusion After PFA Procedure

pericardial effusion, tamponade, pericardial, farawave catheter, pericardiocentesis

reports

Pericardial Effusion with Blood Pressure Drop

cardiac ablation, patient complications, event cardiac, pericardial, result event

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 reportinghigh

Regulatory

FDA recalls for this device

Class I

Jan 5, 2025 · Open, Classified

Due to an observed trend of neurovascular events

Evidence

Related research

When low is not low enough: zero-fluoroscopy atrial fibrillation ablation using the VARIPULSE™ pulsed field system—a prospective single-center study

Edouard Siméon, et al. · Journal of Interventional Cardiac Electrophysiology · 2025

Respiratory control minimizes diaphragmatic contraction and dry cough during pulsed-field ablation of atrial fibrillation.

Jiang R, et al. · 2023

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.