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U.S. Department of Health and Human Services

Medical Device Recalls
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21 to 30 of 60 Results
Recall Status: ��erclassificationtypetext= Submission Number: P100047
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Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Catalog Numbers: 1100, 1101,... 1 04/23/2014 HeartWare Inc
HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated for hemodynamic support i... 2 07/13/2021 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 Controller Product Usage: For use as a bridge-to-cardiac tr... 1 10/17/2016 Heartware, Inc.
HeartWare Ventricular Assist System (HeartWare Controller) Product Usage: For use as a bridge-to... 1 02/25/2015 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). Catalog #'s US: 1101 and 1103 / OUS: 1100, 1101,1102,11... 1 06/08/2015 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 (HVAD) Pump Driveline Splice Kit Product Usage: Is intended... 1 04/25/2017 Heartware
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