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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
PMA Number: P100047
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Product Description
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FDA Recall
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HeartWare HVAD Implant Kit, REF 1104JP 1 08/06/2021 Heartware, Inc.
HeartWare HVAD Implant Kit, REF MCS1705PU 1 08/06/2021 Heartware, Inc.
HeartWare HVAD Outflow Graft, REF MCS1725OG 1 08/06/2021 Heartware, Inc.
HeartWare HVAD Pump Accessories, REF MCS1753AK 1 08/06/2021 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.
Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these system componen... 1 04/16/2021 Heartware, Inc.
Medtronic HVAD Packaged Monitor, Model Numbers: 1500, 1500AU, 1500DE, 1510US, 1511AR, 1511AU, 1511B... 1 04/06/2021 Heartware, Inc.
Medtronic HVAD Battery, Product Number: 1650, 1650CA-CLIN, 1650DE 1 04/06/2021 Heartware, Inc.
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