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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 60 of 60 Results
PMA Number: P100047
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HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100 2 12/02/2023 Heartware, Inc.
HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor 1521GB Exp... 2 06/22/2023 Heartware, Inc.
HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE 1 08/18/2022 Heartware, Inc.
HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) Syst... 1 06/21/2022 Medtronic Inc
HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU 1 06/03/2022 Medtronic Inc
HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH 2 05/17/2022 Heartware, Inc.
HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0 2 05/17/2022 Heartware, Inc.
HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420 2 05/17/2022 Heartware, Inc.
HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit 2 05/17/2022 Heartware, Inc.
HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104 2 05/17/2022 Heartware, Inc.
HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HVAD® System Emergency Re... 2 05/17/2022 Heartware, Inc.
Instructions for Use, Patient Manuals, and Emergency Responder Guides for HeartWare Ventricular Assi... 2 05/17/2022 Medtronic Inc
HeartWare Ventricular Assist Device (HVAD) System 2 03/04/2022 Heartware, Inc.
Medtronic HVAD Pump Implant Kits 2 09/16/2021 Heartware, Inc.
HeartWare HVAD Pump Implant Kit, REF 1103 1 08/06/2021 Heartware, Inc.
HeartWare HVAD Pump Implant Kit, REF 1104 1 08/06/2021 Heartware, Inc.
HeartWare HVAD Pump Implant Kit, REF 1125 1 08/06/2021 Heartware, Inc.
HeartWare HVAD Pump Implant Kit, REF 1153 1 08/06/2021 Heartware, Inc.
HeartWare HVAD Driveline Extension Cable, REF 100 1 08/06/2021 Heartware, Inc.
HeartWare HVAD Driveline Extension Cable, REF 100US 1 08/06/2021 Heartware, Inc.
HeartWare HVAD Implant Kit, REF 1104JP 1 08/06/2021 Heartware, Inc.
HeartWare HVAD Implant Kit, REF MCS1705PU 1 08/06/2021 Heartware, Inc.
HeartWare HVAD Outflow Graft, REF MCS1725OG 1 08/06/2021 Heartware, Inc.
HeartWare HVAD Pump Accessories, REF MCS1753AK 1 08/06/2021 Heartware, Inc.
HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated for hemodynamic support i... 2 07/13/2021 Heartware, Inc.
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.
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 Alarm Adapter, Product Number: 1450 1 04/06/2021 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 Monitor Data Cable, Product Number: 1575 1 04/06/2021 Heartware, Inc.
Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, c. PUMP 1104JP, d. P... 1 02/04/2021 Medtronic Inc
Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125 1 05/22/2020 Heartware, Inc.
Heartware HVAD Pump Implant Kit, Product (REF) Number 1104JP 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 1103 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 AC Adapter The HeartWare HVAD System is indicated for hemod... 1 03/09/2020 Heartware, Inc.
HeartWare HVAD System Battery Charger The HeartWare HVAD System is indicated for hemodynamic sup... 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
HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100,1101,1102,1... 1 06/13/2015 HeartWare Inc
HeartWare Ventricular Assist System (HVAD). Catalog #: 1101, 1103, 1100, 1101, 1102, 1104, 1104JP, ... 1 06/11/2015 HeartWare Inc
HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient... 2 06/10/2015 HeartWare Inc
HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100, 1101,1102,11... 1 06/08/2015 HeartWare Inc
HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended ... 1 05/14/2015 HeartWare Inc
HeartWare Ventricular Assist System (HeartWare Controller) Product Usage: For use as a bridge-to... 1 02/25/2015 HeartWare Inc
HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) - HeartWare Battery For use... 2 05/14/2014 HeartWare Inc
Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Catalog Numbers: 1100, 1101,... 1 04/23/2014 HeartWare Inc
Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) 2 07/29/2013 HeartWare Inc
 
 
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