HVAD Pump Implant Kit Adverse Events: FDA MAUDE Data
Heartware Inc. · Ventricular Assist Device (LVAD) · First cleared Nov 2012 · 3 device variants grouped
Total Reports
3,244
Reports (30d)
14
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Power Cable Damage Causing Alarms
vad remains, assist device, ventricular assist, vad, device vad
11
reports
Unexpected Death with Device Remains
vad remains, assist device, ventricular assist, data registry, device vad
2
reports
Unknown Cause of Patient Death
device therapy, passed away, therapy related, outcome, patient passed
2
reports
Bacterial Driveline Infection Treated with Drugs
driveline infection, patient admitted, infection, therapy, admitted
1
reports
Pump Pocket Infection Post-VAD Exchange
ventricular assist, infection, vad, patients, device vad
1
reports
Unknown Death with Power Log Review
passed away, file, external power, log file, patient passed
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
Mechanical circulatory support devices and treatment strategies for right heart failure
Taiyo Kuroda, et al. · Frontiers in Cardiovascular Medicine · 2022
Early sST2 Liberation after Implantation of a Left Ventricular Assist Device in Patients with Advanced Heart Failure
Philipp L. Opfermann, et al. · Journal of Immunology Research · 2020
Longitudinal assessment of thrombin generation using calibrated automated thrombography in patients with continuous-flow left ventricular assist devices over a five-year period
Agnieszka Anna Kuczaj, et al. · Scientific Reports · 2026
Citations indexed from PubMed.
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