PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104
Reported: December 13, 2023 Initiated: October 31, 2023 #Z-0479-2024
Product Description
PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104
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
Details
- Recalling Firm
- Heartware, Inc.
- Units Affected
- 10287 units
- Distribution
- Worldwide
- Location
- Miami Lakes, FL
Frequently Asked Questions
What product was recalled? ▼
PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104. Recalled by Heartware, Inc.. Units affected: 10287 units.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 13, 2023. Severity: Moderate. Recall number: Z-0479-2024.
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