1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN
This recall is currently active, issued December 2, 2023. It was issued by Heartware, Inc..
- Company
- Heartware, Inc.
- Recall Initiated
- October 31, 2023
- Posted
- December 2, 2023
- Recall Number
- Z-0480-2024
- Quantity
- 6 units
- Firm Location
- Miami Lakes, FL
- Official Source
- View on FDA website ↗
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
Worldwide
Lot / Code Info
Serial numbers: HW24101, HW24102, HW24103, HW24104, HW24763, HW24755FSCA
Root Cause
Labeling design
Action Taken
Heartware issued an URGENT: MEDICAL DEVICE CORRECTION notice to its consignees on 10/31/2023 via letter (UPS). The notice explained the issue and informed them of the updates to the HVAD IFU and PM (patient manual).