Thoratec Corp.
Medical device manufacturer in Pleasanton, CA.
3510(k) clearances
1PMA approvals
40recalls
Device types
510(k) clearances
PMA approvals
- P920014 Heartmate Ve Lvas · 09/30/1994 · 27 supplements
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2520-2026 Class II | Brand Name: HeartMate Product Name: HM 11V Li-ion Backup Battery, ABT Model/Catalog…Due to 11 volt Backup Battery failures. | 05/13/2026Open, Classified |
| Z-2519-2026 Class II | Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number:…Due to 11 volt Backup Battery failures. | 05/13/2026Open, Classified |
| Z-2518-2026 Class II | Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits…Due to 11 volt Backup Battery failures. | 05/13/2026Open, Classified |
| Z-1099-2026 Class II | CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMag RVAD HDE…Acute circulatory support system pump may not fit into the motor and reports received of the pump not being… | 10/10/2025Open, Classified |
| Z-0508-2026 Class II | Brand Name: HeartMate Product Name: HeartMate II Controller (standalone) Model/Catalog…Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup… | 10/09/2025Open, Classified |
| Z-0507-2026 Class II | Brand Name: HeartMate Product Name: HeartMate II LVAS Implant Kit Model/Catalog Number:…Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup… | 10/09/2025Open, Classified |
| Z-0506-2026 Class II | Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/Catalog…Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup… | 10/09/2025Open, Classified |
| Z-0505-2026 Class II | Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits…Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup… | 10/09/2025Open, Classified |
| Z-2291-2025 Class I | Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number: 107754…Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking mechanism… | 06/23/2025Open, Classified |
| Z-2290-2025 Class I | Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/Catalog…Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking mechanism… | 06/23/2025Open, Classified |
| Z-1570-2025 Class I | HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 107758UK, UK…Left Ventricular Assist System Mobile Power Unit (MPU) may have electrical component that may cause MPU not… | 03/13/2025Open, Classified |
| Z-2583-2024 Class II | HeartMate 3 System Controllers provided within the following HeartMate 3 Left…Left ventricular assist system controller UI membrane/screen may lift along the edge of the controller… | 06/25/2024Open, Classified |
| Z-1921-2024 Class I | Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US, L1286A-US…System monitor screen may display atypical behavior: Overlapping screens/buttons, Frozen screen, Distorted… | 05/08/2024Open, Classified |
| Z-1693-2024 Class I | Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnlyPotential for a leak path at the seal interface between the left ventricle assist system inflow cannula and… | 03/01/2024Open, Classified |
| Z-1692-2024 Class I | Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnlyPotential for a leak path at the seal interface between the left ventricle assist system inflow cannula and… | 03/01/2024Open, Classified |
| Z-1301-2024 Class I | HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft…Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left… | 02/19/2024Open, Classified |
| Z-1300-2024 Class I | HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed Outflow Graft…Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left… | 02/19/2024Open, Classified |
| Z-0842-2024 Class I | 1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication…Due to software and controller systems that results in unexpected pump start or pump stop. | 01/03/2024Open, Classified |
| Z-2658-2023 Class II | Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & HeartMate II…Inability to start and/or complete the coring procedure due to inadequate sharpness of the Apical Coring… | 08/07/2023Open, Classified |
| Z-0308-2022 Class II | Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Rental US)…If LVAS communication system is trying to establish Bluetooth connection and another Bluetooth-enabled… | 10/22/2021Open, Classified |
| Z-0746-2020 Class II | HeartMate 3 Mobile Power Unit, REF 107754, UDI or GTIN: 00813024010883, and 107758, UDI…Excessive static electricity can potentially cause unrecoverable power loss and damage to the mobile power… | 12/02/2019Terminated |
| Z-2349-2019 Class II | Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile, REF…Outflow Graft leaking at the pump connection during the implantation process. If the C-Ring is… | 03/30/2019Terminated |
| Z-2348-2019 Class II | Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only, Left…Outflow Graft leaking at the pump connection during the implantation process. If the C-Ring is… | 03/30/2019Terminated |
| Z-1203-2019 Class II | Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an optional…Small black plastic particle was observed in the left ventricle during implant procedure. | 03/01/2019Terminated |
| Z-2053-2017 Class I | HeartMate II LVAS with Pocket Controller; 106762 - HMII POCKET CONTROLLER, NA; UDI:…St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with new software… | 03/30/2017Terminated |
| Z-2052-2017 Class I | HeartMate II LVAS with Pocket Controller; 106015 - HMII LVAD SEALED KIT-PCTRL, NA UDI:…St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with new software… | 03/30/2017Terminated |
| Z-2051-2017 Class I | HeartMate II LVAS with Pocket Controller; 107801 - HMII PUMP & POCKET CTRL ONLY…St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with new software… | 03/30/2017Terminated |
| Z-1230-2014 Class I | Heart Mate II Pocket Controllers removed from packaging Product Usage: HeartMate II is a…Discovery of serious injuries and deaths associated with the process of changing from a primary System… | 03/04/2014Terminated |
| Z-1228-2014 Class I | HeartMate II System Controller Product Usage: HeartMate II is a mechanical device that…Discovery of serious injuries and deaths associated with the process of changing from a primary System… | 03/04/2014Terminated |
| Z-1227-2014 Class I | HeartMate II Implant Kit with Pocket Controller; with sealed grafts (NAm) with sealed…Discovery of serious injuries and deaths associated with the process of changing from a primary System… | 03/04/2014Terminated |
| Z-1228-2012 | HeartMate II Left Ventricular Assist System (HM II LVAS) Sealed Outflow Graft Bend…A trend of disconnected bend reliefs on the sealed outflow graft used with the HeartMate II LVAS has been… | 02/23/2012Terminated |
| Z-0058-2011 | HeartMate II System Controller, a component of the HeartMate II Left Ventricular Device…Connection failure-- product may malfunction because of bent pins or broken wires in power cord connection | 09/01/2010Terminated |
| Z-0422-2010 | HeartMate 12 volt sealed lead acid Battery Clips that are components of the HeartMate II…Patient reports alerted Thoratec that during the process of disconnecting power leads from the battery… | 10/14/2009Terminated |
| Z-0496-2009 | Thoratec Heartmate II Left Ventricular Assist System (LVAS). Model/Catalog Number 1355…The firm has become aware that, over time, wear and fatigue of the percutaneous lead connecting the… | 10/24/2008Terminated |
| Z-0212-2008 | Thoratec Implantable Ventricular Assist Device (IVAD pump) (Component of Thoratec…Pneumatic Leaks: air leaks developing in the pneumatic driveline when subjected to excessive stress at the… | 10/19/2007Terminated |
| Z-1108-2007 | Thoratec TLC-II Portable VAD Driver. Component (pneumatic) driver of Thoratec…Component Failure; Device Failure without warning; due to premature wear-out of the compressor motor, VAD… | 06/08/2007Terminated |
| Z-1109-2007 | Thoratec Paracorporeal Ventricular Assist Device (PVAD) component of the Thoratec VAD…Incorrect collect nut assembly (inadvertent use of the incorrect (Black) collect nut) during surgical… | 03/30/2007Terminated |
| Z-0004-2007 | Thoratec brand TLC-II Portable Ventricular Assist Device (VAD) Driver; Catalog No.…Sticky Valve Disk- The valve disk has an increased tendency to stick during operation causing noise and… | 08/25/2006Terminated |
| Z-0412-2007 | Thoratec Dual Drive Console a drive component of the Thoratec Ventricular Assist Device…The module power switch (at the back of console) may break while attempting to turn the Dual Drive Console… | 09/24/2004Terminated |
| Z-0015-2007 | Thoratec brand Sealed Arterial Cannula for use with the Thoratec Vascular Assist Device…During use an unexpected flaking of the inner surface coating (blood contact) that has the potential for… | 01/26/2004Terminated |