HVAD PUMP IMPLANT KIT Adverse Events: FDA MAUDE Data
Heartware, Inc. · Ventricular Assist Device (LVAD)
Total Reports
194
Reports (30d)
194
Active Signals
1
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
53
reports
Motor Start Event with Low Flow Alarms
vad, complications, use, device vad, vad remains
8
reports
Template Summary: LVAD Outcomes with RVAD Support
outcomes, survival, patients, study, group
4
reports
Patient Death with Unknown Cause
device therapy, passed away, therapy related, outcome, patient passed
2
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
Role of Genetic Polymorphisms in the Development of Complications in Patients with Implanted Left Ventricular Assist Devices: HeartWare, HeartMate II, and HeartMate 3
M. Zhalbinova, et al. · Journal of Clinical Medicine · 2023
Early sST2 Liberation after Implantation of a Left Ventricular Assist Device in Patients with Advanced Heart Failure
Philipp Opfermann, et al. · Journal of Immunology Research · 2020
Mechanical circulatory support devices and treatment strategies for right heart failure
Taiyo Kuroda, et al. · Frontiers in Cardiovascular Medicine · 2022
Longitudinal assessment of thrombin generation using calibrated automated thrombography in patients with continuous-flow left ventricular assist devices over a five-year period
Agnieszka Kuczaj, et al. · Scientific Reports · 2026
Mechanical Device Malfunction of the HeartMate II Versus the HeartMate 3 Left Ventricular Assist Device: The Rotterdam Experience
Cornelis W. van der Heiden, et al. · ASAIO Journal · 2022
Citations indexed from PubMed.
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