HeartLight Adverse Events: FDA MAUDE Data
CARDIOFOCUS, INC. · Cardiac Ablation Catheter for Atrial Fibrillation · First cleared Apr 2016 · 11 device variants grouped
Total Reports
125
Reports (30d)
0
Active Signals
0
Open Recalls
1
Regulatory
FDA recalls for this device
Feb 7, 2025 · Open, Classified
Damage to the sterile barrier pouch of catheter, which could potentially compromise its sterility.
Evidence
Related research
Pulmonary Vein Isolation Using the Visually Guided Laser Balloon: A Prospective, Multicenter, and Randomized Comparison to Standard Radiofrequency Ablation.
Dukkipati SR, et al. · Journal of the American College of Cardiology · 2015
Pivotal Study of a Novel Motor-Driven Endoscopic Ablation System
Boris Schmidt, et al. · Circulation Arrhythmia and Electrophysiology · 2021
Initial multicenter clinical experience with the first-generation endoscopic guided laser balloon in Japan
Masahiko Goya, et al. · Journal of Interventional Cardiac Electrophysiology · 2023
Rapid pulmonary vein isolation utilizing the third-generation laserballoon – The PhoeniX registry
Christian-Hendrik H. Heeger, et al. · IJC Heart & Vasculature · 2020
Visually guided laser ablation for atrial fibrillation: First experience in Greece
Charalampos Kossyvakis, et al. · Hellenic Journal of Cardiology · 2020
Citations indexed from PubMed.
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