ABBOTT (ST. JUDE MEDICAL) · Cardiac Ablation Catheter for Atrial Flutter · First cleared Jan 2012
Total Reports
114
Reports (30d)
1
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Electrode Noise During Ablation Procedure
observed, left, ablation procedure, completed, mapping
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Evidence
Impact of tip design and thermocouple location on the efficacy and safety of radiofrequency application.
Yamaguchi J, et al. · 2022
Efficacy and safety of catheter ablation of atrioventricular nodal re-entrant tachycardia by means of flexible-tip irrigated catheters.
Bertini M, et al. · 2019
A mesh-type flexible tip catheter vs a contact force catheter for catheter ablation of atrial fibrillation: A prospective nonrandomized 1:1 matched study.
Pak HN, et al. · 2020
Slit-based irrigation catheters can reduce procedure-related ischemic stroke in atrial fibrillation patients undergoing radiofrequency catheter ablation.
Kim YG, et al. · 2020
Pentaspline Pulsed Field Ablation Versus High-Power Short-Duration/Very High-Power Short-Duration Radiofrequency Ablation in Atrial Fibrillation: A Meta-Analysis.
Mariani MV, et al. · 2025
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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