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U.S. Department of Health and Human Services

Medical Device Recalls
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11 to 20 of 60 Results
Submission Number: P100047
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Product Description
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HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HVAD® System Emergency Re... 2 05/17/2022 FEI # 3007042319
Heartware, Inc.
Instructions for Use, Patient Manuals, and Emergency Responder Guides for HeartWare Ventricular Assi... 2 05/17/2022 FEI # 3001504994
Medtronic Inc
HeartWare Ventricular Assist Device (HVAD) System 2 03/04/2022 FEI # 3007042319
Heartware, Inc.
Medtronic HVAD Pump Implant Kits 2 09/16/2021 FEI # 3007042319
Heartware, Inc.
HeartWare HVAD Outflow Graft, REF MCS1725OG 1 08/06/2021 FEI # 3007042319
Heartware, Inc.
HeartWare HVAD Pump Accessories, REF MCS1753AK 1 08/06/2021 FEI # 3007042319
Heartware, Inc.
HeartWare HVAD Implant Kit, REF MCS1705PU 1 08/06/2021 FEI # 3007042319
Heartware, Inc.
HeartWare HVAD Implant Kit, REF 1104JP 1 08/06/2021 FEI # 3007042319
Heartware, Inc.
HeartWare HVAD Driveline Extension Cable, REF 100US 1 08/06/2021 FEI # 3007042319
Heartware, Inc.
HeartWare HVAD Driveline Extension Cable, REF 100 1 08/06/2021 FEI # 3007042319
Heartware, Inc.
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