PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104
FDA device recall Z-0479-2024 · posted 2023-12-02 · Open, Classified
Recall details
- Recalling firm
- Heartware, Inc.
- 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
- 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).
- Root cause
- Labeling design
- Status
- Open, Classified
- Product code
- DSQ
- Quantity affected
- 10287 units
- Distribution
- Worldwide
- Date initiated
- 2023-10-31
- Date posted
- 2023-12-02
- Location
- Miami Lakes, FL
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