THORATEC HEARTMATE II, LVAS IMPLANT KIT, US, EP Adverse Events: FDA MAUDE Data
Thoratec Corporation · Ventricular Assist Device (LVAD) · First cleared Apr 2003
Total Reports
192
Reports (30d)
0
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
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
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
Chatterjee S, et al. · The Annals of thoracic surgery · 2004
Sandner SE, et al. · The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation · 2013
Citations indexed from PubMed.
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