PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU
Reported: December 13, 2023 Initiated: October 31, 2023 #Z-0483-2024
Product Description
PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU
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
- 125
- Distribution
- Worldwide
- Location
- Miami Lakes, FL
Frequently Asked Questions
What product was recalled? ▼
PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU. Recalled by Heartware, Inc.. Units affected: 125.
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-0483-2024.
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