FDA-Device2023-12-13Class II
PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104
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
10287 units
Manufactured in
14400 Nw 60th Ave, Miami Lakes, FL, United States
Products
PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0479-2024Don't want to check this manually?
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