HEARTWARE VENTRICULAR ASSIST SYSTEM DRIVELINE Adverse Events: FDA MAUDE Data
Heartware Inc. · Ventricular Assist Device (LVAD)
Total Reports
2,594
Reports (30d)
55
Active Signals
2
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Data Registry: VAD Outcomes Tracking
data registry, outcomes, vad, intermacs, device vad
51
reports
Driveline Sheath Damage with Repair
vad, damage, use, device vad, remains
12
reports
Motor Start Event with Low Flow Alarms
vad, complications, use, device vad, vad remains
4
reports
Patient Death with Unknown Cause
device therapy, passed away, therapy related, outcome, patient passed
1
reports
Template Summary: LVAD Outcomes Analysis
outcomes, survival, patients, study, group
1
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
Citations indexed from PubMed.
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