SMARTABLATE Adverse Events: FDA MAUDE Data
Biosense Webster Inc · Cardiac Ablation Catheter (Percutaneous) · First cleared Mar 2013 · 3 device variants grouped
Total Reports
188
Reports (30d)
13
Active Signals
4
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Cardiac Tamponade Post-Ablation Procedure
reportable, pebax, tubing, patient underwent, procedure thermocool
11
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Evidence
Related research
Comparison of Ablation Index‐Guided Lesion Size in nGEN and SMARTABLATE: An Ex Vivo Porcine Heart Study
Xinru Li, et al. · Pacing and Clinical Electrophysiology · 2026
Improved 1-year outcomes after active cooling during left atrial radiofrequency ablation
Christopher Joseph, et al. · Journal of Interventional Cardiac Electrophysiology · 2023
Safety profile and long-term efficacy of very high-power short-duration (60–70 W) catheter ablation for atrial fibrillation: results of a large comparative analysis
Miruna A. Popa, et al. · EP Europace · 2022
Citations indexed from PubMed.
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