IRVINE BIOMEDICAL, INC. · Intravascular Ultrasound (IVUS) · First cleared May 2014
Total Reports
340
Reports (30d)
7
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Catheter Tip Fracture During Procedure
ice, soundstar, viewflex catheter, ablation, viewflex
12
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Evidence
Perampanel for Early Seizure Prophylaxis After Severe Traumatic Brain Injury: A Retrospective Comparative Study with Levetiracetam.
Onda H, et al. · 2025
Contemporary echocardiographic guiding tools for device closure of interatrial communications.
Bartel T, et al. · 2013
Patent Foramen Ovale Closure for Stroke Prevention and Other Disorders.
Collado FMS, et al. · 2018
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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