Heartware, Inc.: Medical Device Recalls in 2022

According to to data from the FDA, there were 17 medical device recalls made by Heartware, Inc. in 2022. See the details of the recalls below.

You can see similar recalls for other firms.

• HeartWare HVAD Pump Kit, REF 1104CA-CLIN
• HeartWare Model 1101
• HeartWare HVAD Pump Kit, REF 1104
• HeartWare Model 1102
• HeartWare Model 1100
• HeartWare HVAD Pump Kit, REF 1103
• HeartWare HVAD Pump Kit, REF MCS1705PU
• HeartWare HVAD Pump Kit, REF 1104JP
• HeartWare HVAD Pump Kit, REF 1205
• HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE
• HeartWare Ventricular Assist Device (HVAD) System
• HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH
• HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0
• HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit
• HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104
• HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Instructions For Use (FI) HVAD¿ System Instructions For Use (FI) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Instructions For Use - FI HVAD¿ System Instructions For Use (FI) HVAD¿ System OUS Patient Manual (FI-Finnish) HVAD¿ System Emergency Responder Guide (TR-Turkish) HVAD¿ System Patient Manual (TR-Turkish) HVAD¿ System Patient Manual (TR-Turkish) HVAD¿ System Patient Manual (TR-Turkish) HVAD¿ System Patient Manual (TR-Turkish) HVAD¿ System OUS Instructions For Use (TR-Turkish)
• HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420