ClaripulseClaripulse
MAUDE LookupResourcesBlog
LoginGet Early Access
ClaripulseClaripulse

Product

MAUDE LookupDashboard

Guides

FDA MAUDE DatabasePost-Market SurveillanceSignal Detection

Learn

BlogResourcesWhy Claripulse?

Legal

Privacy PolicyTerms of Service

This system analyzes publicly available FDA MAUDE data. It does NOT provide medical advice. MAUDE data is de-identified — do not attempt re-identification. © 2026 Claripulse.

Back to Electrophysiology: Ablation
MAUDE LookupElectrophysiology: AblationThermoCool SF

ThermoCool SF Adverse Events: FDA MAUDE Data

Biosense Webster Inc · Cardiac Ablation Catheter (Percutaneous) · First cleared Nov 2004

Total Reports

1,010

Reports (30d)

0

Active Signals

1

Open Recalls

0

Monthly Report Volume
Event Type Breakdown

Detection

Active safety signals

Disproportionate reportinghigh

Evidence

Related research

Enhanced efficiency of a novel porous tip irrigated RF ablation catheter for pulmonary vein isolation.

Park CI, et al. · 2013

The low acute effectiveness of a high-power short duration radiofrequency current application technique in pulmonary vein isolation for atrial fibrillation

Ekrem Üçer, et al. · Cardiology Journal · 2020

Lesion Size and Safety Comparison Between the Novel Flex Tip on the FlexAbility Ablation Catheter and the Solid Tips on the ThermoCool and ThermoCool SF Ablation Catheters.

Winterfield JR, et al. · 2015

Effects of open-irrigated radiofrequency ablation catheter design on lesion formation and complications: in vitro comparison of 6 different devices.

Guerra JM, et al. · 2013

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

→

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. 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.