Z-0480-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 13, 2023
- Initiation Date
- October 31, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 units
Product Description
1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN
Reason for Recall
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
Distribution Pattern
Worldwide
Code Information
Serial numbers: HW24101, HW24102, HW24103, HW24104, HW24763, HW24755FSCA