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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE
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1
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08/18/2022
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FEI # 3007042319 Heartware, Inc.
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HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) Syst...
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1
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06/21/2022
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FEI # 3001504994 Medtronic Inc
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HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU
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1
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06/03/2022
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FEI # 3001504994 Medtronic Inc
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HeartWare HVAD Pump Accessories, REF MCS1753AK
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1
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08/06/2021
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FEI # 3007042319 Heartware, Inc.
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HeartWare HVAD Outflow Graft, REF MCS1725OG
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1
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08/06/2021
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FEI # 3007042319 Heartware, Inc.
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HeartWare HVAD Implant Kit, REF MCS1705PU
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1
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08/06/2021
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FEI # 3007042319 Heartware, Inc.
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HeartWare HVAD Implant Kit, REF 1104JP
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1
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08/06/2021
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FEI # 3007042319 Heartware, Inc.
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HeartWare HVAD Driveline Extension Cable, REF 100US
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1
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08/06/2021
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FEI # 3007042319 Heartware, Inc.
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HeartWare HVAD Driveline Extension Cable, REF 100
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1
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08/06/2021
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FEI # 3007042319 Heartware, Inc.
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HeartWare HVAD Pump Implant Kit, REF 1153
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1
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08/06/2021
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FEI # 3007042319 Heartware, Inc.
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