THORATEC HEARTMATE II, SYSTEM CONTROLLER, US, EP Adverse Events: FDA MAUDE Data

Thoratec Corporation · Ventricular Assist Device (LVAD) · First cleared Apr 2003

Total Reports

143

Reports (30d)

Active Signals

Open Recalls

Monthly Report Volume

Event Type Breakdown

Regulatory

FDA recalls for this device

Class II

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.

Class II

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.

Class II

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.

Class II

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.

Class I

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.

Class I

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

Morgan JA, et al. · The Journal of thoracic and cardiovascular surgery · 2004

McIlvennan CK, et al. · Circulation. Heart failure · 2014

LVAD as a Bridge to Transplantation—Current Status and Future Perspectives

Maximilian J. Roesel, et al. · Reviews in Cardiovascular Medicine · 2024

Spiliopoulos K, et al. · Cardiology research and practice · 2012

Tabit CE, et al. · Circulation · 2016

Citations indexed from PubMed.

Keep exploring

Related devices in MCS

Impella

Abiomed, Inc. · 43,110 reports

→

HVAD Pump Implant Kit

MEDTRONIC, INC. · 37,651 reports

→

HeartMate 3

Thoratec Corporation · 24,019 reports

→

HeartMate

Thoratec Corporation · 16,616 reports

→

CARDIOSAVE HYBRID, TYPE B PLUG

Datascope Corp. · 13,507 reports

→

THORATEC HEARTMATE, LVAS IMPLANT KIT (WITH SEALED GRAFTS)

Thoratec Corporation · 7,235 reports

→

Want automated safety signal detection?

Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more.

Get Early Access

Understanding this data

What FDA MAUDE data does and does not tell you

How these reports are filed, why raw counts mislead, and the limits to know before drawing conclusions.

→

How a safety signal is detected

What the "Active Signals" count above means and the methods that separate a real signal from noise.

→

Disclaimer: This system analyzes publicly available FDA MAUDE data. It does NOT provide medical advice. MAUDE data is de-identified. Do not attempt re-identification. Report counts may differ from the FDA's MAUDE search due to processing cadence and deduplication. Data is updated weekly.