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Thoratec LLC

12 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/ recall (Z-2518-2026)Thoratec LLC2026-06-18
Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 1 recall (Z-2519-2026)Thoratec LLC2026-06-18
Brand Name: HeartMate Product Name: HM 11V Li-ion Backup Battery, ABT Model/Catalog Number recall (Z-2520-2026)Thoratec LLC2026-06-18
CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMag RVAD HDE KIT recall (Z-1099-2026)Thoratec LLC2026-01-15
Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/ recall (Z-0505-2026)Thoratec LLC2025-11-14
Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/Catalog Numb recall (Z-0506-2026)Thoratec LLC2025-11-14
Brand Name: HeartMate Product Name: HeartMate II LVAS Implant Kit Model/Catalog Number: 10 recall (Z-0507-2026)Thoratec LLC2025-11-14
Brand Name: HeartMate Product Name: HeartMate II Controller (standalone) Model/Catalog Num recall (Z-0508-2026)Thoratec LLC2025-11-14
Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/Catalog Number: recall (Z-2290-2025)Thoratec LLC2025-08-13
Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number: 107754 Softwar recall (Z-2291-2025)Thoratec LLC2025-08-13
HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 107758UK, UK; L107 recall (Z-1570-2025)Thoratec LLC2025-04-17
HeartMate 3 System Controllers provided within the following HeartMate 3 Left Ventricular recall (Z-2583-2024)Thoratec LLC2024-08-13

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Every clearance here is in the API, with alerts when new ones post.