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
5,803
Reports (30d)
39
Active Signals
7
Open Recalls
0
Monthly Report Volume
Event Type Breakdown
Detection
Active safety signals
Disproportionate reportinghighIncreasing trendcriticalDisproportionate reportinghighDisproportionate reportinghighDisproportionate reportinghighDisproportionate reportinghigh
Keep exploring
Related devices in Ablation
Want automated safety signal detection?
Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more. 7 active signals detected right now.
Get Early AccessUnderstanding this data
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.