FDAOctober 31, 2023device
1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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
FDA enforcement status: Ongoing
Brands named
heartware
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAPUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP2023-10-31
- FDAPUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 11042023-10-31
- FDAHVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 12052023-10-31
- FDAPUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 11032023-10-31
- FDAHVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 11002023-10-31
- FDAHVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 11022023-10-31
- FDASTERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 11012023-10-31
- FDAPUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU2023-10-31
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