Official recall record
PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP
- 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
- Barcode (EAN/GTIN)
- 00763000170967
- 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.
Record last checked against the registry on 2026-05-31.
Same barcode in other registries
The same EAN appears in 1 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.
- 2022-04-14 · US FDA — Medical Devices
HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU
Other recalls from this brand
- 2023-10-31 · US FDA — Medical Devices
PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104 - 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
HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100
All 5 official recall notices naming Heartware, Inc. on this site →