ThermoCool SmartTouch SF Adverse Events: FDA MAUDE Data

Biosense Webster Inc · Cardiac Ablation Catheter (Percutaneous) · First cleared Nov 2004 · 10 device variants grouped

Total Reports

5,721

Reports (30d)

Active Signals

Open Recalls

Monthly Report Volume

Event Type Breakdown

Detection

Active safety signals

Disproportionate reportinghighDisproportionate reportinghighDisproportionate reportinghighDisproportionate reportinghighDisproportionate reportinghighDisproportionate reportinghigh

Evidence

Related research

Acute procedural safety of the latest radiofrequency ablation catheters in atrial fibrillation ablation: Data from a large prospective ablation registry

Hirofumi Arai, et al. · Journal of Cardiovascular Electrophysiology · 2024

Characteristics of tissue temperature during ablation with THERMOCOOL SMARTTOUCH SF versus TactiCath versus QDOT MICRO catheters (Qmode and Qmode+): An in vivo porcine study

Naoto Otsuka, et al. · Journal of Cardiovascular Electrophysiology · 2023

Dual energy for pulmonary vein isolation using focal ablation technology integrated with a three-dimensional mapping system: SmartfIRE 12-month results.

De Potter T, et al. · 2025

Safety and effectiveness of very-high-power, short-duration ablation in patients with atrial fibrillation: Preliminary results

Karolina Mitrzak, et al. · Cardiology Journal · 2023

Citations indexed from PubMed.

Keep exploring

Related devices in Ablation

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

→

QDOT MICRO

Biosense Webster Inc · 933 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. 6 active signals 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.