THORATEC HEARTMATE II, SYSTEM CONTROLLER Adverse Events: FDA MAUDE Data
Thoratec Corporation · Ventricular Assist Device (LVAD) · First cleared Apr 2003
Total Reports
1,344
Reports (30d)
9
Active Signals
0
Open Recalls
11
What the reports describe · Claripulse analysis
Most commonly reported problems
Damaged Controller Cable Nut
backup, controller exchanged, damage, connected, log file
3
reports
Concern for Pump Thrombus
thrombosis, file, elevated, log file, thrombus
2
reports
System Controller Exchange After Alarm
primary, connected, unusual, review log, files submitted
2
reports
Communication Failure with System Controller
expected, backup, appeared, connected, heartmate
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
May 13, 2026 · Open, Classified
Due to 11 volt Backup Battery failures.
May 13, 2026 · Open, Classified
Due to 11 volt Backup Battery failures.
May 13, 2026 · Open, Classified
Due to 11 volt Backup Battery failures.
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.
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