FlexAbility Adverse Events: FDA MAUDE Data
ABBOTT (ST. JUDE MEDICAL) · Cardiac Ablation Catheter for Atrial Flutter · First cleared Jan 2015 · 16 device variants grouped
Total Reports
355
Reports (30d)
1
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Inconsistent Irrigation Flow During Ablation
observed, thermocool, ablation procedure, patients, study
3
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
Impact of tip design and thermocouple location on the efficacy and safety of radiofrequency application.
Yamaguchi J, et al. · Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2022
Slit-based irrigation catheters can reduce procedure-related ischemic stroke in atrial fibrillation patients undergoing radiofrequency catheter ablation.
Kim YG, et al. · PloS one · 2020
Clinical and procedural outcomes of very high-power short-duration vs. standard power ablation for pulmonary vein isolation.
Rodrigues I, et al. · Frontiers in cardiovascular medicine · 2026
Citations indexed from PubMed.
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