Biosense Webster Inc · Cardiac Ablation Catheter (Percutaneous) · First cleared Nov 2004
Total Reports
494
Reports (30d)
23
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Irrigation Failure with Pericardial Effusion
pericardial effusion, flow, pericardial, effusion, pericardiocentesis
18
reports
Pebax Surface Hole Before Ablation
product analysis, pebax, analysis lab, webster product, evaluation
12
reports
Force Issue with Visual Inspection
mdr reportable, visual, finding mdr, medtech, visual inspection
10
reports
Literature Batch: Hybrid Ablation Safety
left, qty, bwi devices, patients, left atrial
8
reports
Pebax Hole Identified Post-Operation
mdr reportable, pebax, customer, hole pebax, pal
5
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Evidence
Radiofrequency ablation using the ThermoCool SmartTouch Catheter guided by ablation index versus antiarrhythmic drugs in atrial fibrillation treatment in China: a cost-consequence analysis.
Zhang B, et al. · 2024
Optimal ablation settings of TactiFlex SE laser-cut irrigated-tip catheter: comparison with ThermoCool SmartTouch SurroundFlow porous irrigated-tip catheter.
Suga K, et al. · 2024
Colocalized radiofrequency and pulsed field ablation of incessant ventricular tachycardia with suspected intramural circuit in ischaemic cardiomyopathy using a 3.5 mm single-tip catheter under eCPR: a case report.
Borlich M, et al. · 2026
Combined transapical transcatheter aortic valve implantation and premature ventricular contraction ablation in a high-risk cardiomyopathy patient: a case report.
Li YB, et al. · 2025
Real-world evaluation of intracardiac echocardiography guided radio-frequency catheter ablation for atrial fibrillation: a retrospective cohort study.
Tong Y, et al. · 2024
Citations indexed from PubMed.
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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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