THORATEC HEARTMATE II, LVAS IMPLANT KIT Adverse Events: FDA MAUDE Data
Thoratec Corporation · Ventricular Assist Device (LVAD) · First cleared Apr 2003
Total Reports
682
Reports (30d)
2
Active Signals
0
Open Recalls
11
What the reports describe · Claripulse analysis
Most commonly reported problems
Right Ventricular Dysfunction Outcomes Analysis
outcomes, valve repair, tricuspid, patients, group
2
reports
Bacterial Infection with Arrhythmia
requiring, infection, admitted, considered, included
1
reports
Concern for Pump Thrombus
thrombosis, file, elevated, log file, thrombus
1
reports
Driveline Tear with Asymptomatic Patient
external, previously, captured, damage, modular cable
1
reports
Low Flow Alarms with Normal Parameters
flow alarms, file, flow events, low flow, outflow
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.
Evidence
Related research
Fitzgibbon J, et al. · The Journal of emergency medicine · 2016
Roçi E, et al. · AME case reports · 2023
Blankstein R, et al. · Journal of the American College of Cardiology · 2013
Citations indexed from PubMed.
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