ViewFlex Adverse Events: FDA MAUDE Data
IRVINE BIOMEDICAL, INC. · Intravascular Ultrasound (IVUS) · First cleared May 2014 · 2 device variants grouped
Total Reports
363
Reports (30d)
1
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Catheter Distal Tip Fracture
journal, study, philips volcano, journal article, listed
7
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Evidence
Related research
Accuracy of a Deep Learning Model in Intracardiac Echocardiography
Devi Nair, et al. · JACC Advances · 2026
Ablação Por Cateter Sem Uso de Fluoroscopia Para Tratamento de Fibrilação Atrial e Arritmias Atriais: Eficácia e Segurança
Eduardo Saad, et al. · Arquivos Brasileiros de Cardiologia · 2020
Three-dimensional intracardiac echocardiography for left atrial appendage sizing and percutaneous occlusion guidance
Domenico Giovanni Della Rocca, et al. · EP Europace · 2023
Safety and efficacy of left atrial appendage occlusion with the ACP or Watchman device guided by intracardiac echocardiography from the left atrium
Thibaut Pommier, et al. · Clinical Cardiology · 2021
Zero‐fluoroscopy ablation for cardiac arrhythmias: A single‐center experience in Japan
Tohru Kawakami, et al. · Journal of Arrhythmia · 2021
Citations indexed from PubMed.
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