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U.S. Department of Health and Human Services

Medical Device Recalls

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51 to 60 of 60 Results
Recall Date to: 05%2F08%2F2014 PMA Number: P100047
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Product Description
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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 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 Battery, Lithium Ion, 14.8 V, Rx only. Catalog 1650 (... 1 07/08/2016 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
Instructions for Use, Patient Manuals, and Emergency Responder Guides for HeartWare Ventricular Assi... 2 05/17/2022 Medtronic 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
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