FDAApril 3, 2020device
Heartware HVAD Pump Implant Kit, Product (REF) Number 1104
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump.
What to do
FDA enforcement status: Ongoing
Brands named
heartware
UPCs
008887070020280088870700238700888707001649008887070005810088870700241700888707002493008887070024000088870700254700888707000680008887070023940088870700023900888707002530
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDA1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN2023-10-31
- 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 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP2023-10-31
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