HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205
Reported: December 13, 2023 Initiated: October 31, 2023 #Z-0482-2024
Product Description
HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205
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
- 126 units
- Distribution
- Worldwide
- Location
- Miami Lakes, FL
Frequently Asked Questions
What product was recalled? ▼
HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205. Recalled by Heartware, Inc.. Units affected: 126 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-0482-2024.
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