Heartware, Inc. recalls PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103

Recall date

October 31, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0478-2024

FDA classification

Class II

Brand / firm

Heartware, Inc.

Sold / distributed

Worldwide

Why it was recalled

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 means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103