FDA-Device2023-12-13Class II
PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU
Heartware, Inc.
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
Sold states
Worldwide
Affected count
125
Manufactured in
14400 Nw 60th Ave, Miami Lakes, FL, United States
Products
PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0483-2024Don't want to check this manually?
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