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Heartware, Inc. recalls STERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101
Recalled December 13, 2023 · FDA recall Z-0476-2024 · Heartware
Hazard
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 · FDA Class II
Units
380 units
Sold at
Worldwide
Description
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
Product
STERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101
Manufacturer(s)
Heartware, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →