PENTARAY NAV Adverse Events: FDA MAUDE Data
Biosense Webster Inc · Intracardiac Mapping Catheter, High-Density · First cleared May 2012 · 12 device variants grouped
Total Reports
1,006
Reports (30d)
17
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Irrigation Failure with No Water Flow
pentaray, nav catheter, procedure pentaray, water, pentaray nav
26
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
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Kohei Iwasa, et al. · Canadian Journal of Cardiology · 2022
Ablation of visually identified spatiotemporal dispersion plus pulmonary vein isolation in persistent atrial fibrillation
Eduardo Franco, et al. · European Heart Journal Open · 2026
Citations indexed from PubMed.
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