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Heartware, Inc.: Medical Device Recalls in 2023

Updated on March 25, 2026.

According to to data from the FDA, there were 10 medical device recalls made by Heartware, Inc. in 2023. See the details of the recalls below.

You can see similar recalls for other firms.

Data Source: FDA.
See this for other years:
2013
2014
2015
2016
2018
2020
2021
2022
2023
  • HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205
  • HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100
  • 1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN
  • PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104
  • STERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101
  • PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP
  • HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1102
  • PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103
  • PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU
  • HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor 1521GB Explore Tech, c) Monitor 1521IL Explore Tech, d) Monitor 1521DE Explore Tech
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