ViewFlex Adverse Events: FDA MAUDE Data
IRVINE BIOMEDICAL, INC. · Intravascular Ultrasound (IVUS) · First cleared May 2014
Total Reports
351
Reports (30d)
3
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Fractured Tip on Catheter
replaced, viewflex catheter, ablation, viewflex, consequences
12
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
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