Device product

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

Z-0480-2024

October 31, 2023

Class II

Product summary

Firm: Heartware, Inc.
Event: Event 93405
Status: Ongoing
Classification: Class II
Quantity: 6 units
Official record key: device-enforcement:Z-0480-2024

Official wording

Reason: 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

Code information: Serial numbers: HW24101, HW24102, HW24103, HW24104, HW24763, HW24755FSCA

Distribution pattern: Worldwide

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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