HeartMate 3 Adverse Events: FDA MAUDE Data
Thoratec Corporation · Ventricular Assist Device (LVAD) · First cleared Apr 2003 · 39 device variants grouped
Total Reports
24,019
Reports (30d)
379
Active Signals
2
Open Recalls
8
What the reports describe · Claripulse analysis
Most commonly reported problems
Patient Death with Unknown Cause
device therapy, passed away, therapy related, outcome, patient passed
124
reports
Template Summary: LVAD Outcomes with RVAD Support
outcomes, survival, patients, study, group
105
reports
Low Flow Alarms with Normal Vital Signs
flow alarms, flows, flow events, low flow, outflow
75
reports
Driveline Infection Leading to Pump Exchange
driveline infection, infection, therapy, surgical, patients
47
reports
Post-Transplant Device Non-Evaluation
device therapy, transplant, therapy related, outcome, underwent
35
reports
Emergency Backup Battery Fault Detected
backup battery, ebb, controller exchanged, emergency, faults
33
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Regulatory
FDA recalls for this device
Oct 9, 2025 · Open, Classified
Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
Oct 9, 2025 · Open, Classified
Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
Oct 9, 2025 · Open, Classified
Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
Oct 9, 2025 · Open, Classified
Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
Jun 23, 2025 · Open, Classified
Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking mechanism from properly engaging with the Mobile Power Unit and may cause unintended disconnect.
Jun 23, 2025 · Open, Classified
Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking mechanism from properly engaging with the Mobile Power Unit and may cause unintended disconnect.
Evidence
Related research
Optimal cannula positioning of HeartMate 3 left ventricular assist device
Teruhiko Imamura, et al. · Artificial Organs · 2020
Primary results of long‐term outcomes in the <scp>MOMENTUM</scp> 3 pivotal trial and continued access protocol study phase: a study of 2200 <scp>HeartMate</scp> 3 left ventricular assist device implants
Mandeep R. Mehra, et al. · European Journal of Heart Failure · 2021
Center Variability in Patient Outcomes Following HeartMate 3 Implantation: An Analysis of the MOMENTUM 3 Trial
Manreet Kanwar, et al. · Journal of Cardiac Failure · 2022
Extrinsic outflow graft obstruction of the HeartMate 3 LVAD: A state-of-the-art review
Daniel J. Goldstein, et al. · The Journal of Heart and Lung Transplantation · 2024
Comparing Short-Term Outcome after Implantation of the HeartWare® HVAD® and the Abbott® HeartMate 3®
René Schramm, et al. · ESC Heart Failure · 2020
Citations indexed from PubMed.
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