medical Class II Updated 2023-12-13

Heartware, Inc. recalls 1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUM

Recalled Product

1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN

Hazard / Issue

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

Issued by

FDA

Distribution: Worldwide
Lot/Code Info: Serial numbers: HW24101, HW24102, HW24103, HW24104, HW24763, HW24755FSCA
View official government recall

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