THORATEC HEARTMATE II, SYSTEM CONTROLLER Adverse Events: FDA MAUDE Data
Thoratec Corporation · Ventricular Assist Device (LVAD) · First cleared Apr 2003
Total Reports
1,335
Reports (30d)
2
Active Signals
0
Open Recalls
8
What the reports describe · Claripulse analysis
Most commonly reported problems
Backup Controller Failure with Driveline Disconnect
captured, backup, connected, log file, review log
2
reports
Controller Disconnection During Pump Priming
backup, considered, function, connected, heartmate
1
reports
Controller Fault Alarm with Exchange
non, captured, controller exchanged, issues, fault alarm
1
reports
Low Voltage Alarms from Battery Depletion
battery, ebb, external power, batteries, low voltage
1
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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