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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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HeartMate 3 System Controllers provided within the following HeartMate 3 Left Ventricular Assist Sys...
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2
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08/13/2024
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Thoratec LLC
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HeartMate 3 Mobile Power Unit, REF 107754, UDI or GTIN: 00813024010883, and 107758, UDI or GTIN: 008...
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2
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12/27/2019
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Thoratec Corp.
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Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only, Left Ventricular Assis...
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2
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08/22/2019
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Thoratec Corp.
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Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile, REF 105581US/105581, RX only, P...
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2
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08/22/2019
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Thoratec Corp.
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Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an optional accessory of Thora...
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2
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04/19/2019
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Thoratec Corp.
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Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US, L1286A-US, 1286C, L128...
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1
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06/07/2024
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Thoratec Corp.
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Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly
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1
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05/01/2024
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Thoratec Corp.
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Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
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1
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05/01/2024
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Thoratec Corp.
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HeartMate 3 Left Ventricular Assist System (LVAS):
1. HeartMate 3 Sealed Outflow Graft with Bend Re...
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1
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03/22/2024
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Thoratec Corp.
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1. HeartMate Touch Communication System, REF HMT1100
2. HeartMate Touch Communication System, Renta...
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1
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02/02/2024
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Thoratec Corp.
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