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Thoratec Corp

Last updated September 17, 2026

Information

Country: US
Address: 4550 Norris Canyon Rd, San Ramon, CA, 94583
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EUDAMED SRN: —
FDA FEI Number: 3008792657
DUNS Number: —

Catalogue (224)

Page 5 of 5

Device	Model / Reference	Registries	Class	Status
Thoratec® Heartmate Ii®, Inflow Conduit	102564	FDA UDI	Class III	Active
Thoratec® Vad, Sealed Arterial Cannula, Short, Straight, 14mm	100118	FDA UDI	Class III	Active
Tlc- Ii System Driver	100621U	FDA UDI	Class III	Active
Thoratec® Tunneler Replacement Sheath, Standard Curve	10002-6001-002	FDA UDI	Class II	Active
Heartmate®, Power Module Patient Cable 12v	2225	FDA UDI	Class III	Active
Thorate® VAD, Surgical Implant Accessory Kit	20002-2615-001	FDA UDI	Class III	Active
Thoratec® One Tunneler Assembly Standard Curve, With One Extra Tip & Sheath	10002-6001-001	FDA UDI	Class II	Active
Thoratec® Heartmate® Gogear®, Battery Holster	104234	FDA UDI	Class III	Active
Thoratec® Heartmate®, System Monitor	1286	FDA UDI	Class III	Active
HeartMate™ GoGear™	106129	FDA UDI	Class III	Active
Thoratec® Heartmate® Gogear®, Modular Belt, Large	104228	FDA UDI	Class III	Active
Thoratec® HeartMate 3™	106528US	FDA UDI	Class III	Active
HeartMate II®, System Controller	105472	FDA UDI	Class III	Active
Thoratec® Heartmate Ii®, Lvas Implant Kit, Us, Ep	103695	FDA UDI	Class III	Active
Thoratec® Heartmate Ii®, Lvas Implant Kit (with Sealed Grafts)	104911	FDA UDI	Class III	Active
HeartMate II®, System Controller	105109	FDA UDI	Class III	Active
Heartmate®, Display Module To Power Module Adapter Cable	103871	FDA UDI	Class III	Active
Thoratec® Heartmate® Xve And Heartmate Ii®, Apical Coring Knife	1050	FDA UDI	Class III	Active
Thoratec® Heartmate® Gogear®, Holster Vest, Small	104224	FDA UDI	Class III	Active
Thoratec®, Hearttouch® Tablet And Accessories	105400	FDA UDI	Class III	Active
Thoratec CentriMag Return (Arterial) Cannula Kit	K152161	FDA 510(k)	Class II	Active
Centrimag Primary Console (2nd Generation); Mag Monitor	K131179	FDA 510(k)	Class II	Active
Thoratec CentriMag Drainage (Venous) Cannula Kit	K152190	FDA 510(k)	Class II	Active
Tci Heartmate(r) 1000a Ip Lvad	P920014	FDA PMA	Class III	Active

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FDA Recalls (40)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Oct 10, 2025	Z-1099-2026	—	open, classified	Acute circulatory support system pump may not fit into the motor and reports received of the pump not being securely locked into the motor using the screw-in locking feature. Failure to properly lock the pump into motor my not cause pump not inserted alarm, and could lead to particulate, increased heat, anxiety, inconvenience, delay in hemodynamic/ECMO support, stroke, embolism, death.
Oct 9, 2025	Z-0505-2026	—	open, classified	Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
Oct 9, 2025	Z-0506-2026	—	open, classified	Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
Oct 9, 2025	Z-0508-2026	—	open, classified	Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
Oct 9, 2025	Z-0507-2026	—	open, classified	Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
Jun 23, 2025	Z-2291-2025	—	open, classified	Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking mechanism from properly engaging with the Mobile Power Unit and may cause unintended disconnect.
Jun 23, 2025	Z-2290-2025	—	open, classified	Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking mechanism from properly engaging with the Mobile Power Unit and may cause unintended disconnect.
Mar 13, 2025	Z-1570-2025	—	open, classified	Left Ventricular Assist System Mobile Power Unit (MPU) may have electrical component that may cause MPU not to turn on, unprompted shut down, or turning off/restarting, may cause system controller to indicate Yellow Wrench or No External Power alarms. If MPU losses power, System Controller can support the pump up to 15 minutes, and if not switched to rechargeable batteries, pump may lose power.
Jun 25, 2024	Z-2583-2024	—	open, classified	Left ventricular assist system controller UI membrane/screen may lift along the edge of the controller housing, and if controller is exposed to fluid, ingress may occur, which may damage printed circuit board assemblies, which could result in unexpected and false positive alarms, loss of visual alarms, loss of user interface(use of buttons, loss of visual alarms,etc.), loss of power, and pump stop
May 8, 2024	Z-1921-2024	—	open, classified	System monitor screen may display atypical behavior: Overlapping screens/buttons, Frozen screen, Distorted text, blanks, or zeroes in place of values, Unresponsive buttons where the user is unable to initiate a command, which may lead to anxiety /inconvenience, hemodynamic compromise, extended surgical time, and Pump Stop command may be selected
Mar 1, 2024	Z-1693-2024	—	open, classified	Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff.
Mar 1, 2024	Z-1692-2024	—	open, classified	Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff.
Feb 19, 2024	Z-1300-2024	—	open, classified	Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System.
Feb 19, 2024	Z-1301-2024	—	open, classified	Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System.
Jan 3, 2024	Z-0842-2024	—	open, classified	Due to software and controller systems that results in unexpected pump start or pump stop.
Aug 7, 2023	Z-2658-2023	—	open, classified	Inability to start and/or complete the coring procedure due to inadequate sharpness of the Apical Coring Knife, provided with Left Ventricular Assist System, could result in an extended procedure or surgical time while the backup coring knife is acquired.
Oct 22, 2021	Z-0308-2022	—	open, classified	If LVAS communication system is trying to establish Bluetooth connection and another Bluetooth-enabled device is nearby and advertising for Bluetooth connection, the Bluetooth connectivity interference may cause the system App to close or fail to open. Once Bluetooth adaptor is connected, barring disconnection, all functionality is unaffected; the device will continue to operate as expected.
Dec 2, 2019	Z-0746-2020	—	terminated	Excessive static electricity can potentially cause unrecoverable power loss and damage to the mobile power unit that can be used to power the left ventricular assist system, which could lead to no or reduced blood flow from the left ventricular assist system.
Mar 30, 2019	Z-2348-2019	—	terminated	Outflow Graft leaking at the pump connection during the implantation process. If the C-Ring is insufficiently seated, it renders the device nonfunctional because the Outflow Graft connection will leak during the implant procedure.
Mar 30, 2019	Z-2349-2019	—	terminated	Outflow Graft leaking at the pump connection during the implantation process. If the C-Ring is insufficiently seated, it renders the device nonfunctional because the Outflow Graft connection will leak during the implant procedure.
Mar 1, 2019	Z-1203-2019	—	terminated	Small black plastic particle was observed in the left ventricle during implant procedure.
Mar 30, 2017	Z-2051-2017	—	terminated	St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with new software and updates to hardware to make the exchange to a backup controller easier. This is related to recall Z-1227/1230-2014.
Mar 30, 2017	Z-2053-2017	—	terminated	St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with new software and updates to hardware to make the exchange to a backup controller easier. This is related to recall Z-1227/1230-2014.
Mar 30, 2017	Z-2052-2017	—	terminated	St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with new software and updates to hardware to make the exchange to a backup controller easier. This is related to recall Z-1227/1230-2014.
Mar 4, 2014	Z-1230-2014	—	terminated	Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to their back-up System controller in patients using the Pocket System controller model.
Mar 4, 2014	Z-229-2014	—	terminated	Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to their back-up System controller in patients using the Pocket System controller model.
Mar 4, 2014	Z-1227-2014	—	terminated	Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to their back-up System controller in patients using the Pocket System controller model.
Mar 4, 2014	Z-1228-2014	—	terminated	Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to their back-up System controller in patients using the Pocket System controller model.
Feb 23, 2012	Z-1228-2012	—	terminated	A trend of disconnected bend reliefs on the sealed outflow graft used with the HeartMate II LVAS has been identified
Sep 1, 2010	Z-0058-2011	—	terminated	Connection failure-- product may malfunction because of bent pins or broken wires in power cord connection
Oct 14, 2009	Z-0422-2010	—	terminated	Patient reports alerted Thoratec that during the process of disconnecting power leads from the battery clips, the threaded connector of the battery clip housing was observed to be loose, and in some cases dislodged from the battery clip housing. The problem affects HeartMate 12V SLA Battery Clips including those used for the HeartMate II LVAS and HeartMate XVE systems. If not detected and handled
Oct 24, 2008	Z-0496-2009	—	terminated	The firm has become aware that, over time, wear and fatigue of the percutaneous lead connecting the HeartMate II Left Ventricular Assist System (HM II LVAS) blood pump with external system controller may result in damage that has the potential to interrupt pump function and may require a reoperation to replace the pump.
Oct 19, 2007	Z-0212-2008	—	terminated	Pneumatic Leaks: air leaks developing in the pneumatic driveline when subjected to excessive stress at the junction of the percutaneous line to the pump housing due to sharp bending when implanted (paracorporeal-external-position).
Jun 8, 2007	Z-1108-2007	—	terminated	Component Failure; Device Failure without warning; due to premature wear-out of the compressor motor, VAD support for the patient's circulatory system may fail without warning.
Mar 30, 2007	Z-1109-2007	—	terminated	Incorrect collect nut assembly (inadvertent use of the incorrect (Black) collect nut) during surgical implantation (wrong size collect nut) to secure the inflow cannula to the PVAD has resulted in patient deaths
Aug 25, 2006	Z-0004-2007	—	terminated	Sticky Valve Disk- The valve disk has an increased tendency to stick during operation causing noise and pressure/vacuum alarms.
Sep 24, 2004	Z-0412-2007	—	terminated	The module power switch (at the back of console) may break while attempting to turn the Dual Drive Console OFF or ON.
Jan 26, 2004	Z-0015-2007	—	terminated	During use an unexpected flaking of the inner surface coating (blood contact) that has the potential for risk of embolism.
Feb 7, 2003	Z-0688-03	—	terminated	Driveline tubing connections on the SVL if under STRESS condition may snap off, VAD support is compromised, a serious injury or death can occur.
Dec 16, 2002	Z-0491-03	—	terminated	The product is mislabeled, in that the LVAD Pneumatic Lead 5' is identified with a BLUE Collar (instead of Red) in order to distinguish RVAD.