ViewFlex Adverse Events: FDA MAUDE Data
IRVINE BIOMEDICAL, INC. · Intravascular Ultrasound (IVUS) · First cleared May 2014
Total Reports
358
Reports (30d)
4
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Catheter Fracture with No Consequences
adverse, catheter replaced, soundstar, effusion, consequences
5
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
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