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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 25 of 35 Results
Firm: HeartWare
 
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Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartw... 2 04/21/2021 Heartware, Inc.
Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Hear... 2 04/20/2021 Heartware, Inc.
Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these system componen... 1 04/16/2021 Heartware, Inc.
Power Supply: 1. Medtronic HVAD Controller AC Adapter, Product Numbers: 1425AU, 1425CA, 1425DE, 14... 1 04/06/2021 Heartware, Inc.
Medtronic HVAD Controller, Product Numbers: 1400, 1401, 1401AU, 1401BR, 1401CA, 1401CH, 1401DE, 140... 1 04/06/2021 Heartware, Inc.
Medtronic HVAD Alarm Adapter, Product Number: 1450 1 04/06/2021 Heartware, Inc.
Medtronic HVAD Packaged Monitor, Model Numbers: 1500, 1500AU, 1500DE, 1510US, 1511AR, 1511AU, 1511B... 1 04/06/2021 Heartware, Inc.
Medtronic HVAD Battery, Product Number: 1650, 1650CA-CLIN, 1650DE 1 04/06/2021 Heartware, Inc.
Medtronic HVAD Monitor Data Cable, Product Number: 1575 1 04/06/2021 Heartware, Inc.
Heartware HVAD Pump Implant Kit, Product (REF) Number 1103 1 05/22/2020 Heartware, Inc.
Heartware HVAD Pump Implant Kit, Product (REF) Number 1104 1 05/22/2020 Heartware, Inc.
Heartware HVAD Pump Implant Kit, Product (REF) Number 1104JP 1 05/22/2020 Heartware, Inc.
Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125 1 05/22/2020 Heartware, Inc.
Heartware HVAD Pump Implant accessories, Product (REF) Number 1153 1 05/22/2020 Heartware, Inc.
HeartWare HVAD System Battery Charger The HeartWare HVAD System is indicated for hemodynamic sup... 1 03/09/2020 Heartware, Inc.
HeartWare HVAD System Battery Charger AC Adapter The HeartWare HVAD System is indicated for hemod... 1 03/09/2020 Heartware, Inc.
Medtronic HeartWare Ventricular Assist HVAD System Battery Charger Model 1600US - Product Usage: The... 2 12/07/2018 Heartware, Inc.
Heart Ware(TM) HVAD(TM) System Controller/Controller Kits, Model Numbers: 1403, 1407, and 1420 P... 2 10/03/2018 Heartware, Inc.
Heartware Medtronic HVAD System for cardiac use. Including the following parts: (a) Controller / ... 1 05/21/2018 Heartware
HeartWare HVAD System Controller The HeartWare Ventricular Assist System (VAS is indicated for use... 1 04/27/2017 Heartware
HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended... 1 04/25/2017 Heartware
HeartWare Ventricular Assist System Controller Product Usage: For use as a bridge-to-cardiac tr... 1 10/17/2016 Heartware, Inc.
HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103; and International Product:... 1 10/13/2016 HeartWare, Inc
HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, Rx only. Catalog 1650 (... 1 07/08/2016 Heartware, Inc.
HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patien... 2 06/26/2015 HeartWare Inc
 
 
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