FDA Enforcement
Class II
Ongoing
1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN
Recall: Z-0480-2024
·
Reported December 13, 2023
Enforcement
- Recall Number
- Z-0480-2024
- Event ID
- 93405
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Heartware, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- December 13, 2023
- Initiation Date
- October 31, 2023
- Classification Date
- December 1, 2023
- Address
- 14400 Nw 60th Ave, Miami Lakes, FL, 33014-2807, United States
Description
1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN
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 Info
Serial numbers: HW24101, HW24102, HW24103, HW24104, HW24763, HW24755FSCA
Distribution
Worldwide
Quantity
6 units