HeartWare Controller Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Ventricular Assist Device (LVAD) · First cleared Nov 2012
Total Reports
2,310
Reports (30d)
1
Active Signals
0
Open Recalls
69
Regulatory
FDA recalls for this device
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
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
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
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
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
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. · ASAIO journal (American Society for Artificial Internal Organs : 1992) · 2014
A Sensorless Modular Multiobjective Control Algorithm for Left Ventricular Assist Devices: A Clinical Pilot Study
Martin Maw, et al. · Frontiers in Cardiovascular Medicine · 2022
Third-Generation Continuous-Flow Left Ventricular Assist Devices: A Comparative Outcome Analysis by Device Type
Maks Mihalj, et al. · ESC Heart Failure · 2022
The left ventricular assist device as a patient monitoring system
Francesco Moscato, et al. · Annals of Cardiothoracic Surgery · 2021
Citations indexed from PubMed.
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