Recall Z-0479-2024— Heartware, Inc.
Class II · Ongoing
Class II FDA medical device recall by Heartware, Inc., initiated 2023-10-31. FDA's recall record names no specific 510(k) clearance for this event. Product: PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104. 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.
- Recalling firm
- Heartware, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-10-31
- Firm location
- Miami Lakes, FL, United States
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.