Heartware recalls
Heartware appears in 75 official U.S. recall notices indexed by RecallRadar.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- Heartware HVAD Pump Implant accessories, Product (REF) Number 1153
FDA Device · Class I · 2020-06-03 · Heartware - Heartware HVAD Pump Implant Kit, Product (REF) Number 1104
FDA Device · Class I · 2020-06-03 · Heartware - Heartware HVAD Pump Implant Kit, Product (REF) Number 1103
FDA Device · Class I · 2020-06-03 · Heartware - Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125
FDA Device · Class I · 2020-06-03 · Heartware - HeartWare HVAD System Battery Charger AC Adapter The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced,…
FDA Device · Class I · 2020-03-18 · Heartware - HeartWare HVAD System Battery Charger The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory…
FDA Device · Class I · 2020-03-18 · Heartware - Medtronic HeartWare Ventricular Assist HVAD System Battery Charger Model 1600US - Product Usage: The HeartWare Ventricular Assist System (H…
FDA Device · Class II · 2018-12-19 · Heartware - Heart Ware(TM) HVAD(TM) System Controller/Controller Kits, Model Numbers: 1403, 1407, and 1420 Product Usage: The HeartWare HVAD System is…
FDA Device · Class II · 2018-10-10 · Heartware - Heartware Medtronic HVAD System for cardiac use
FDA Device · Class I · 2018-06-06 · Heartware - HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once an elect…
FDA Device · Class I · 2017-05-03 · Heartware - HeartWare HVAD System Controller The HeartWare Ventricular Assist System (VAS is indicated for use as a bridge-to-cardiac transplantation i…
FDA Device · Class I · 2017-05-03 · Heartware - HeartWare Ventricular Assist System Controller Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of…
FDA Device · Class I · 2016-10-26 · Heartware - HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103
FDA Device · Class I · 2016-10-19 · Heartware - HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, Rx only
FDA Device · Class I · 2016-07-20 · Heartware - HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refracto…
FDA Device · Class II · 2015-07-08 · Heartware - HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100,1101,1102,1104,1104JP and 1205
FDA Device · Class I · 2015-06-24 · Heartware - HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refracto…
FDA Device · Class II · 2015-06-17 · Heartware - HeartWare Ventricular Assist System (HVAD). Catalog #: 1101, 1103, 1100, 1101, 1102, 1104, 1104JP, and 1205
FDA Device · Class I · 2015-06-17 · Heartware - HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100, 1101,1102,1104,1104JP and 1205
FDA Device · Class I · 2015-06-17 · Heartware - HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once an elect…
FDA Device · Class I · 2015-05-20 · Heartware - HeartWare Ventricular Assist System (HeartWare Controller) Product Usage: For use as a bridge-to-cardiac transplantation in patients who ar…
FDA Device · Class I · 2015-03-04 · Heartware - HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) - HeartWare Battery For use as a bridge-to-cardiac transplantation in…
FDA Device · Class II · 2014-05-21 · Heartware - Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Catalog Numbers: 1100, 1101, 1102, 1103, 1104, and 1205
FDA Device · Class I · 2014-04-30 · Heartware - Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
FDA Device · Class II · 2013-08-07 · Heartware - Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
FDA Device · Class II · 2013-05-22 · Heartware