FDA-Device2023-12-13Class II
1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN
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
6 units
Manufactured in
14400 Nw 60th Ave, Miami Lakes, FL, United States
Products
1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0480-2024Don't want to check this manually?
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