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This system analyzes publicly available FDA MAUDE data. It does NOT provide medical advice. MAUDE data is de-identified — do not attempt re-identification. © 2026 Claripulse.

Back to Mechanical Circulatory Support
MAUDE LookupMechanical Circulatory SupportHeartMate 3

HeartMate 3 Adverse Events: FDA MAUDE Data

Thoratec Corporation · Ventricular Assist Device (LVAD) · First cleared Apr 2003 · 32 device variants grouped

Total Reports

22,317

Reports (30d)

401

Active Signals

5

Open Recalls

8

Monthly Report Volume
No timeline data available.
Event Type Breakdown
No event type data available.

Detection

Active safety signals

Increasing trendmediumDisproportionate reportinghighDisproportionate reportinghighDisproportionate reportinghighDisproportionate reportinghigh

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

Single-beat right ventricular-pulmonary artery coupling and residual heart failure in patients with a HeartMate 3 left ventricular assist device.

Castagna F, et al. · 2026

Feasibility of the PSCOPE hybrid model for predicting post-left ventricular assist device hemodynamics: Three patient-specific cases.

Umo AE, et al. · 2025

Post-LVAD diuretic trajectories and predictors of diuretic resistance.

Borović S, et al. · 2026

Citations indexed from PubMed.

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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.

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How a safety signal is detected

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

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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.