THORATEC HEARTMATE, LVAS IMPLANT KIT (WITH SEALED GRAFTS) Adverse Events: FDA MAUDE Data
Thoratec Corporation · Ventricular Assist Device (LVAD) · First cleared Apr 2003
Total Reports
7,235
Reports (30d)
19
Active Signals
0
Open Recalls
8
What the reports describe · Claripulse analysis
Most commonly reported problems
Patient Death with Unknown Cause
device therapy, passed away, therapy related, outcome, patient passed
8
reports
Log Review Shows No Unusual Events
equipment, captured, recorded, log file, unusual
4
reports
Driveline Infection Leading to Pump Exchange
driveline infection, infection, therapy, surgical, patients
3
reports
Template Summary: LVAD Outcomes with RVAD Support
outcomes, survival, patients, study, group
2
reports
Power Loss During MPU Transition
battery, unit mpu, power unit, mpu, mobile power
2
reports
Severe Biventricular Failure with RVAD Exchange
left, right, right ventricular, blood, bleeding
2
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.
Evidence
Related research
Aday U, et al. · Archives of medical sciences. Atherosclerotic diseases · 2017
Pagani FD, et al. · Journal of the American College of Cardiology · 2009
Tscharre M, et al. · Pharmaceuticals (Basel, Switzerland) · 2022
Chandra D, et al. · Texas Heart Institute journal · 2007
Rigatelli G, et al. · Journal of geriatric cardiology : JGC · 2012
Citations indexed from PubMed.
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