Cardiva VASCADE 5F VCS Adverse Events: FDA MAUDE Data
CARDIVA MEDICAL, INC. · Vascular Hemostasis/Closure Device · First cleared Jan 2013
Total Reports
112
Reports (30d)
3
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Device Stuck in Access Site
closure right, pre placed, close technique, prostyle, prostyle device
1
reports
Indicator Failure Prevents Deployment
exoseal, indicator, exoseal vcd, sheath introducer, exoseal vascular
1
reports
Sealant Failure During Deployment
control vascular, mynx control, balloon, verified, sealant
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
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