HeartMate 3 Adverse Events: FDA MAUDE Data
Thoratec Corporation · Ventricular Assist Device (LVAD) · First cleared Apr 2003 · 32 device variants grouped
Total Reports
23,083
Reports (30d)
379
Active Signals
5
Open Recalls
8
What the reports describe · Claripulse analysis
Most commonly reported problems
Proximal Stenosis of Outflow Graft
flow alarms, flow, low flow, outflow graft, outflow
103
reports
Literature Batch: LVAD Mortality Outcomes
implantation, patients, heartmate, study, group
81
reports
Emergency Backup Battery Fault
backup battery, fault, ebb, emergency, faults
54
reports
Chronic Driveline Infection Treatment
left, infection, related, therapy, underwent
52
reports
Driveline Communication Fault Alarm
fault, modular, cable, power fault, driveline power
50
reports
Patient Death with Unknown Cause
passed away, outcome, patient passed, explanted, death
48
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.
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