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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 7 of 7 Results
PMA Number: P160054
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HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Re... 1 03/22/2024 Thoratec Corp.
1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Renta... 1 02/02/2024 Thoratec Corp.
HeartMate 3 Mobile Power Unit, REF 107754, UDI or GTIN: 00813024010883, and 107758, UDI or GTIN: 008... 2 12/27/2019 Thoratec Corp.
Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only, Left Ventricular Assis... 2 08/22/2019 Thoratec Corp.
Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile, REF 105581US/105581, RX only, P... 2 08/22/2019 Thoratec Corp.
Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an optional accessory of Thora... 2 04/19/2019 Thoratec Corp.
Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM ... 1 05/17/2018 Abbott
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