NaviStar ThermoCool Adverse Events: FDA MAUDE Data

Biosense Webster Inc · Cardiac Ablation Catheter for Atrial Flutter · First cleared Nov 2004

Total Reports

143

Reports (30d)

Active Signals

Open Recalls

Monthly Report Volume

Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

Electrode Noise During Ablation Procedure

observed, left, ablation procedure, completed, mapping

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 II

Sep 7, 2022 · Open, Classified

Manufacturing error resulted in potential contamination of Bi-Directional navigation catheter irrigation path with cellulose fibers that can cause 1) Failure of initial flushing inspection, 2) Insufficient irrigation causing catheter tip temperature increase, limiting the ability to deliver ablation, or 3) particles flushed through the catheter irrigation may have thrombogenic/toxic effect.

Evidence

Related research

Pulsed-Field Ablation for Atrial Premature Complexes From the Right Atrial Appendage Apex: A Novel Application.

Geng L, et al. · 2025

Comparison Between Efficacy and Safety of Remote Magnetic Navigation and Manual Catheter Navigation for Atrial Fibrillation Ablation: An Updated Meta-analysis and Systematic Review.

Ijaz R, et al. · 2025

Left atrial intramural hematoma following right atrial catheter ablation: A rare case involving coronary sinus injury.

Hatsuno M, et al. · 2025

Long-term of epicardial radiofrequency ablation and benefit for recurrent ventricular arrhythmia in Brugada syndrome: A systematic review and meta-analysis.

Adji AS, et al. · 2025

Periprocedural acute haemodynamic decompensation during substrate-based ablation of scar-related ventricular tachycardia: a rare and unpredictable event.

Stojadinović P, et al. · 2024

Citations indexed from PubMed.

Keep exploring

Related devices in Ablation

ThermoCool SmartTouch SF

Biosense Webster Inc · 5,721 reports

→

FARAWAVE

BOSTON SCIENTIFIC CORPORATION · 4,178 reports

→

Arctic Front Advance Pro

MEDTRONIC, INC. · 1,667 reports

→

PulseSelect

MEDTRONIC, INC. · 1,542 reports

→

TactiCath

ABBOTT (ST. JUDE MEDICAL) · 1,044 reports

→

ThermoCool SF

Biosense Webster Inc · 1,010 reports

→

Want automated safety signal detection?

Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more. 1 active signal detected right now.

Get Early Access

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.

→

How a safety signal is detected

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

→

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.