HeartMate Adverse Events: FDA MAUDE Data
Thoratec Corporation · Ventricular Assist Device (LVAD) · First cleared Apr 2008
Total Reports
16,616
Reports (30d)
35
Active Signals
0
Open Recalls
8
What the reports describe · Claripulse analysis
Most commonly reported problems
Power Loss During MPU Transition
battery, unit mpu, power unit, mpu, mobile power
66
reports
Patient Death with Unknown Cause
device therapy, passed away, therapy related, outcome, patient passed
50
reports
Template Summary: LVAD Outcomes with RVAD Support
outcomes, survival, patients, study, group
29
reports
Persistent Driveline Power Fault Alarm
modular, fault alarm, power fault, modular cable, driveline power
7
reports
Power Cable Damage Causing Low Voltage Alarms
battery, captured, vad, log file, mpu
6
reports
Driveline Infection Leading to Pump Exchange
driveline infection, infection, therapy, surgical, patients
6
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
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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