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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 16 Results
PMA Number: P160054
 
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Product Description
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FDA Recall
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1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Renta... 1 02/02/2024 FEI # 2916596
Thoratec Corp.
Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/Catalog Number: 1065... 2 11/14/2025 FEI # 2916596
Thoratec LLC
Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog ... 2 11/14/2025 FEI # 2916596
Thoratec LLC
Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number: 107754 Software Versi... 1 08/13/2025 FEI # 2916596
Thoratec LLC
Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/Catalog Number: 107760 ... 1 08/13/2025 FEI # 2916596
Thoratec LLC
HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Re... 1 03/22/2024 FEI # 2916596
Thoratec Corp.
HeartMate 3 Mobile Power Unit, REF 107754, UDI or GTIN: 00813024010883, and 107758, UDI or GTIN: 008... 2 12/27/2019 FEI # 2916596
Thoratec Corp.
HeartMate 3 System Controllers provided within the following HeartMate 3 Left Ventricular Assist Sys... 2 08/13/2024 FEI # 2916596
Thoratec LLC
HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 107758UK, UK; L107758, EU Re... 1 04/17/2025 FEI # 2916596
Thoratec LLC
Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an optional accessory of Thora... 2 04/19/2019 FEI # 2916596
Thoratec Corp.
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