Heartware, Inc.
10 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Heartware, Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2023-12-13FDA-DeviceClass IIPUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU
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
- 2023-12-13FDA-DeviceClass IIHVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205
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
- 2023-12-13FDA-DeviceClass IIPUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP
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
- 2023-12-13FDA-DeviceClass II1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN
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
- 2023-12-13FDA-DeviceClass IIPUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104
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
- 2023-12-13FDA-DeviceClass IIPUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103
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
- 2023-12-13FDA-DeviceClass IIHVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1102
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
- 2023-12-13FDA-DeviceClass IISTERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101
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
- 2023-12-13FDA-DeviceClass IIHVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100
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
- 2023-06-28FDA-DeviceClass IIHeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor 1521GB Explore Tech, c) Monitor 1521IL Explore Tech, d) Monitor 1521DE Explore Tech
Medtronic has identified that the logfiles downloaded from the recently updated Model 1521 monitors (Serial Numbers: MON4xxxxxx for OUS and MON5xxxxxx for US), are unable to be processed by the Autologs web portal.
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