HeartMate Adverse Events: FDA MAUDE Data
Thoratec Corporation · Ventricular Assist Device (LVAD) · First cleared Apr 2008
Total Reports
16,874
Reports (30d)
135
Active Signals
0
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
88
reports
No External Power Alarm During Use
mobile, power unit, external power, mpu, mobile power
29
reports
Mobile Power Unit Alarm Noise
mobile, unit mpu, power unit, mpu, mobile power
23
reports
Damaged Controller Cable Nut
backup, controller exchanged, damage, connected, log file
18
reports
Right Ventricular Dysfunction Outcomes Analysis
outcomes, valve repair, tricuspid, patients, group
18
reports
Power Cable Damage Causing Alarms
vad remains, assist device, ventricular assist, vad, device vad
16
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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