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HeartWare Controller Adverse Events: FDA MAUDE Data

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

Total Reports

2,293

Reports (30d)

1

Active Signals

1

Open Recalls

69

Monthly Report Volume

Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

1

Unspecified Hematological Issue Reported

received report, data registry, vad, registry does, device vad

7

reports

2

Controller Loss of Power During Review

disconnect, data, use, occurred, remains

2

reports

3

Controller Fault Alarm Due to Battery

battery, controller exchanged, exchanged, fault alarm, remains

1

reports

4

Motor Start Event with Fault Alarms

battery, vad, device vad, alarm, alarms

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

HeartWare controller logs a diagnostic tool and clinical management aid for the HVAD pump.

Chorpenning K, et al. · 2014

Third-Generation Continuous-Flow Left Ventricular Assist Devices: A Comparative Outcome Analysis by Device Type

Maks Mihalj, et al. · ESC Heart Failure · 2022

A Sensorless Modular Multiobjective Control Algorithm for Left Ventricular Assist Devices: A Clinical Pilot Study

Martin Maw, et al. · Frontiers in Cardiovascular Medicine · 2022

HFA of the ESC Position Paper on the Management of LVAD Supported Patients for the Non LVAD Specialist Healthcare Provider Part 1: Introduction and at the Non-Hospital Settings in the Community

Binyamin Ben Avraham, et al. · ESC Heart Failure · 2021

Citations indexed from PubMed.

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Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more. 1 active signal detected right now.

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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.