HeartWare Controller Adverse Events: FDA MAUDE Data
Heartware Inc. · Ventricular Assist Device (LVAD) · First cleared Nov 2012
Total Reports
1,164
Reports (30d)
1
Active Signals
2
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
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
HeartWare controller logs a diagnostic tool and clinical management aid for the HVAD pump.
Chorpenning K, et al. · ASAIO journal (American Society for Artificial Internal Organs : 1992) · 2014
Continuous LVAD monitoring reveals high suction rates in clinically stable outpatients
Christoph Gross, et al. · Artificial Organs · 2020
A Sensorless Modular Multiobjective Control Algorithm for Left Ventricular Assist Devices: A Clinical Pilot Study
Martin Maw, et al. · Frontiers in Cardiovascular Medicine · 2022
Citations indexed from PubMed.
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