Heartware, Inc.
59 recalls on record · Latest: Dec 13, 2023
FDA Devices Critical Jun 24, 2015
HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100,1101,1102,1104,1104JP and 1205. For use as a bridge-to-ca…
FDA Devices Moderate Jun 17, 2015
HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-sta…
FDA Devices Critical Jun 17, 2015
HeartWare Ventricular Assist System (HVAD). Catalog #: 1101, 1103, 1100, 1101, 1102, 1104, 1104JP, and 1205. Intended for use as a bridge to card…
FDA Devices Critical Jun 17, 2015
HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100, 1101,1102,1104,1104JP and 1205. Product Usage: For use …
FDA Devices Critical Mar 4, 2015
HeartWare Ventricular Assist System (HeartWare Controller) Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at r…
FDA Devices Moderate May 21, 2014
HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) - HeartWare Battery For use as a bridge-to-cardiac transplantation in patien…
FDA Devices Critical Apr 30, 2014
Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Catalog Numbers: 1100, 1101, 1102, 1103, 1104, and 1205. For use as a bridge…
FDA Devices Moderate Aug 7, 2013
Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
FDA Devices Moderate May 22, 2013