HeartMate GoGear Adverse Events: FDA MAUDE Data

Thoratec Corporation · Ventricular Assist Device (LVAD) · First cleared Aug 2017

Total Reports

100

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

Burki S, et al. · Vascular health and risk management · 2017

Conway J, et al. · Journal of the American Heart Association · 2020

Mehra MR, et al. · European heart journal · 2024

Citations indexed from PubMed.

Keep exploring

Related devices in MCS

Impella

Abiomed, Inc. · 42,167 reports

→

HVAD Pump Implant Kit

MEDTRONIC, INC. · 37,599 reports

→

HeartMate 3

Thoratec Corporation · 23,639 reports

→

HeartMate

Thoratec Corporation · 16,451 reports

→

CARDIOSAVE HYBRID, TYPE B PLUG

Datascope Corp. · 13,331 reports

→

THORATEC HEARTMATE, LVAS IMPLANT KIT (WITH SEALED GRAFTS)

Thoratec Corporation · 7,216 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.