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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 10 of 13 Results
PMA Number: P100047
 
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HeartWare Ventricular Assist System Controller Product Usage: For use as a bridge-to-cardiac tr... 1 Oct-17-2016 HeartWare Inc
HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103; and International Product:... 1 Oct-13-2016 HeartWare, Inc
HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, Rx only. Catalog 1650 (... 1 Jul-08-2016 HeartWare Inc
HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patien... 2 Jun-26-2015 HeartWare Inc
HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100,1101,1102,1... 1 Jun-13-2015 HeartWare Inc
HeartWare Ventricular Assist System (HVAD). Catalog #: 1101, 1103, 1100, 1101, 1102, 1104, 1104JP, ... 1 Jun-11-2015 HeartWare Inc
HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient... 2 Jun-10-2015 HeartWare Inc
HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100, 1101,1102,11... 1 Jun-08-2015 HeartWare Inc
HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended ... 1 May-14-2015 HeartWare Inc
HeartWare Ventricular Assist System (HeartWare Controller) Product Usage: For use as a bridge-to... 1 Feb-25-2015 HeartWare Inc
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