HEARTMATE, MOBILE POWER UNIT, NA Adverse Events: FDA MAUDE Data
Thoratec Corporation · Ventricular Assist Device (LVAD) · First cleared Apr 2008
Total Reports
3,337
Reports (30d)
57
Active Signals
1
Open Recalls
11
What the reports describe · Claripulse analysis
Most commonly reported problems
External Power Loss with Controller Battery Depletion
log files, battery, controller, files, power
19
reports
Low-Flow Alarms from Outflow Graft Obstruction
log files, events, flow, files, low flow
4
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
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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