Official recall record
PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2023-10-31
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Brand on record
- Heartware, Inc.
What the authority reported
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
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2023-10-31 · US FDA — Medical Devices
HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100 - 2023-10-31 · US FDA — Medical Devices
PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103 - 2023-10-31 · US FDA — Medical Devices
PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP
All 5 official recall notices naming Heartware, Inc. on this site →
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