Biosense Webster Inc · Cardiac Ablation Catheter (Percutaneous) · First cleared May 2000
Total Reports
156
Reports (30d)
0
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Irrigation Failure with Pericardial Effusion
pericardial effusion, flow, pericardial, effusion, pericardiocentesis
4
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
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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.
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