THORATEC HEARTMATE II, LVAS IMPLANT KIT (WITH SEALED GRAFTS) Adverse Events: FDA MAUDE Data
Thoratec Corporation · Ventricular Assist Device (LVAD) · First cleared Apr 2003
Total Reports
972
Reports (30d)
3
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
Unknown Cause of Patient Death
device therapy, passed away, therapy related, outcome, patient passed
1
reports
Unknown Death with Power Log Review
passed away, file, external power, log file, patient passed
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.
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THORATEC HEARTMATE, LVAS IMPLANT KIT (WITH SEALED GRAFTS)
Thoratec Corporation · 7,254 reports
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