SMARTABLATE Adverse Events: FDA MAUDE Data
Biosense Webster Inc · Cardiac Ablation Catheter (Percutaneous) · First cleared May 2000
Total Reports
175
Reports (30d)
12
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Irrigation Failure During Atrial Ablation
pebax, tubing, patient underwent, patient experienced, procedure thermocool
7
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
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
Point-by-Point Pulsed Field Ablation Using a Multimodality Generator and a Contact Force–Sensing Ablation Catheter: Comparison With Radiofrequency Ablation in a Remapped Chronic Swine Heart
Luigi Di Biase, et al. · Circulation Arrhythmia and 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 Popa, et al. · EP Europace · 2022
Citations indexed from PubMed.
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