HeartMate 3 Adverse Events: FDA MAUDE Data
Thoratec Corporation · Ventricular Assist Device (LVAD) · First cleared Apr 2003 · 39 device variants grouped
Total Reports
24,385
Reports (30d)
374
Active Signals
2
Open Recalls
11
What the reports describe · Claripulse analysis
Most commonly reported problems
Unknown Cause of Patient Death
device therapy, passed away, therapy related, outcome, patient passed
144
reports
Low Flow Alarms with Normal Parameters
flow alarms, file, flow events, low flow, outflow
115
reports
Right Ventricular Dysfunction Outcomes Analysis
outcomes, valve repair, tricuspid, patients, group
81
reports
Power Cable Damage Causing Alarms
vad remains, assist device, ventricular assist, vad, device vad
56
reports
Bacterial Driveline Infection Treated with Drugs
driveline infection, patient admitted, infection, therapy, admitted
49
reports
Backup Battery Fault Alarms
backup battery, fault, ebb, emergency, faults
31
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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