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U.S. Department of Health and Human Services

Medical Device Recalls

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11 to 20 of 47 Results
Submission Number: P100047
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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), US product: Model No.: 1103; and International Product:... 1 10/13/2016 HeartWare, Inc
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) Pump Driveline Splice Kit Product Usage: Is intended... 1 04/25/2017 Heartware
HeartWare HVAD System Controller The HeartWare Ventricular Assist System (VAS is indicated for use... 1 04/27/2017 Heartware
Heartware Medtronic HVAD System for cardiac use. Including the following parts: (a) Controller / ... 1 05/21/2018 Heartware
Heart Ware(TM) HVAD(TM) System Controller/Controller Kits, Model Numbers: 1403, 1407, and 1420 P... 2 10/03/2018 Heartware, Inc.
Medtronic HeartWare Ventricular Assist HVAD System Battery Charger Model 1600US - Product Usage: The... 2 12/07/2018 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.
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