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U.S. Department of Health and Human Services

Medical Device Recalls

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11 to 20 of 60 Results
Recall Status: ��erclassificationtypetext= Submission Number: P100047
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Medtronic HVAD Pump Implant Kits 2 09/16/2021 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.
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 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) For use as a bridge-to-cardiac transplantation in patient... 2 06/10/2015 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) 2 07/29/2013 HeartWare Inc
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