Thoratec recalls
Thoratec appears in 31 official U.S. recall notices indexed by RecallRadar, most recently on 2026-06-24.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A Product Description…
FDA Device · Class II · 2026-06-24 · Thoratec - Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US Software Version: N/A Pr…
FDA Device · Class II · 2026-06-24 · Thoratec - Brand Name: HeartMate Product Name: HM 11V Li-ion Backup Battery, ABT Model/Catalog Number: 106128 Software Version: N/A Product Descriptio…
FDA Device · Class II · 2026-06-24 · Thoratec - CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016
FDA Device · Class II · 2026-01-21 · Thoratec - Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/Catalog Number: 106531US, HeartMate 3 Controller, US
FDA Device · Class II · 2025-11-26 · Thoratec - Brand Name: HeartMate Product Name: HeartMate II¿ LVAS Implant Kit Model/Catalog Number: 106015, HeartMate II¿ LVAS Kit, with Pocket Contro…
FDA Device · Class II · 2025-11-26 · Thoratec - Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US, HeartMate 3 LVAS KIT, US
FDA Device · Class II · 2025-11-26 · Thoratec - Brand Name: HeartMate Product Name: HeartMate II¿ Controller (standalone) Model/Catalog Number: 106017, HeartMate II¿ Pocket Controller, US
FDA Device · Class II · 2025-11-26 · Thoratec - Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/Catalog Number: 107760 Software Version: N/A Product Description…
FDA Device · Class I · 2025-08-20 · Thoratec - Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number: 107754 Software Version: N/A Product Description: The HeartMate…
FDA Device · Class I · 2025-08-20 · Thoratec - HeartMate Mobile Power Unit: REF: 107754, NA
FDA Device · Class I · 2025-04-23 · Thoratec - HeartMate 3 System Controllers provided within the following HeartMate 3 Left Ventricular Assist System (LVAS) Implant Kits or distributed…
FDA Device · Class II · 2024-08-21 · Thoratec - Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US, L1286A-US, 1286C, L1286C, L1386, 1286A-CAN, 1286INT and L1286…
FDA Device · Class I · 2024-06-19 · Thoratec - Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
FDA Device · Class I · 2024-05-08 · Thoratec - Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly
FDA Device · Class I · 2024-05-08 · Thoratec - HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed Outflow Graft with Bend Relief REF 103393 2. HeartMate II LVAS I…
FDA Device · Class I · 2024-03-27 · Thoratec - HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (…
FDA Device · Class I · 2024-03-27 · Thoratec - 1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3. HeartMate Touch Commu…
FDA Device · Class I · 2024-02-14 · Thoratec - Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT
FDA Device · Class II · 2023-10-11 · Thoratec - Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Rental US), HMT1150 (EU)
FDA Device · Class II · 2021-12-08 · Thoratec - HeartMate 3 Mobile Power Unit, REF 107754, UDI or GTIN: 00813024010883, and 107758, UDI or GTIN: 00813024010890, when connected to the Hear…
FDA Device · Class II · 2020-01-08 · Thoratec - Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only, Left Ventricular Assist System
FDA Device · Class II · 2019-08-28 · Thoratec - Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile, REF 105581US/105581, RX only, Part of Left Ventricular Assist Device (…
FDA Device · Class II · 2019-08-28 · Thoratec - Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an optional accessory of Thoratec HeartMate 3 Left Ventricular Assist…
FDA Device · Class II · 2019-05-01 · Thoratec - HeartMate¿ II LVAS with Pocket Controller
FDA Device · Class I · 2017-05-31 · Thoratec - HeartMate¿ II LVAS with Pocket Controller
FDA Device · Class I · 2017-05-31 · Thoratec - HeartMate¿ II LVAS with Pocket Controller
FDA Device · Class I · 2017-05-31 · Thoratec - HeartMate II LVAD Pump and Pock Controller Kit
FDA Device · Class I · 2014-04-02 · Thoratec - HeartMate II Implant Kit with Pocket Controller
FDA Device · Class I · 2014-04-02 · Thoratec - Heart Mate II Pocket Controllers removed from packaging Product Usage: HeartMate II is a mechanical device that circulates blood throughout…
FDA Device · Class I · 2014-04-02 · Thoratec - HeartMate II System Controller Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart…
FDA Device · Class I · 2014-04-02 · Thoratec