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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 Lookup Mechanical Circulatory SupportHVAD Controller

HVAD Controller Adverse Events: FDA MAUDE Data

MEDTRONIC, INC. · Ventricular Assist Device (LVAD) · First cleared Nov 2012

Total Reports

3,882

Reports (30d)

20

Active Signals

1

Open Recalls

69

Monthly Report Volume

Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

1

Controller Fault Alarm Due to Battery

battery, controller exchanged, exchanged, fault alarm, remains

18

reports

2

Controller Loss of Power During Review

disconnect, data, use, occurred, remains

8

reports

3

Motor Start Event with Fault Alarms

battery, vad, device vad, alarm, alarms

8

reports

4

Controller Defect Leading to Exchange

battery, backup, controller exchanged, exchanged, cable

2

reports

5

Recurrent Driveline Power Fault Alarm

fault, driveline, modular, driveline power, modular cable

1

reports

6

Repeated Backup Battery Fault Alarms

backup battery, fault, ebb, exchanged, alarm

1

reports

Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.

Detection

Active safety signals

Disproportionate reportinghigh

Regulatory

FDA recalls for this device

Class II

Oct 31, 2023 · Open, Classified

Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components

Class II

Oct 31, 2023 · Open, Classified

Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components

Class II

Oct 31, 2023 · Open, Classified

Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components

Class II

Oct 31, 2023 · Open, Classified

Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components

Class II

Oct 31, 2023 · Open, Classified

Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components

Class II

Oct 31, 2023 · Open, Classified

Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components

Evidence

Related research

Unexpected Restart Failure of Durable Left Ventricular Assist Devices: A Report of Two Cases.

Seo HW, et al. · 2024

Left Ventricular Assist Device Management in the Emergency Department.

Trinquero P, et al. · 2018

The left ventricular assist device as a patient monitoring system.

Moscato F, et al. · 2021

Fully Elman Neural Network: A Novel Deep Recurrent Neural Network Optimized by an Improved Harris Hawks Algorithm for Classification of Pulmonary Arterial Wedge Pressure.

Fetanat M, et al. · 2022

Afterload pressure and left ventricular contractility synergistically affect left atrial pressure during veno-arterial ECMO.

Jiang J, et al. · 2023

Citations indexed from PubMed.

Keep exploring

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HeartMate

Thoratec Corporation · 16,109 reports

CARDIOSAVE HYBRID, TYPE B PLUG

Datascope Corp. · 12,800 reports

THORATEC HEARTMATE, LVAS IMPLANT KIT (WITH SEALED GRAFTS)

Thoratec Corporation · 7,148 reports

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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.

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.