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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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PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3008792657
DUNS Number: —

Catalogue (224)

Page 1 of 5

Device	Model / Reference	Registries	Class	Status
CentriMag™	102961	FDA UDI	Class II	Active
Thoratec® Vad, Sealed Arterial Cannula, Extra Long, Straight, 18mm	100166	FDA UDI	Class III	Active
Thoratec® HeartMate 3™ Surgical Hand Tools	10002222US	FDA UDI	Class III	Active
Thoratec® Heartmate® Xve And Heartmate Ii®, Display Module	1280N	FDA UDI	Class III	Active
Thoratec® Heartmate Ii®, Sealed Outflow Bend Relief Collar	107315	FDA UDI	Class III	Active
HeartMate™ GoGear™	104229	FDA UDI	Class III	Active
Thoratec® Vad, Sealed Arterial Cannula, Long, Straight, 18mm	100129	FDA UDI	Class III	Active
Thoratec® HeartMate 3™ VAD Modular Cable	106525US	FDA UDI	Class III	Active
HeartMate 3™	106532US	FDA UDI	Class III	Active
HeartMate™	1260	FDA UDI	Class III	Active
Heartmate® Power Module (na)	1340	FDA UDI	Class III	Active
Thoratec® Hearmate Ii®, Sealed Inflow Conduit	104142Y	FDA UDI	Class III	Active
Tlc-Ii, Power Supply External	20010-2825-001	FDA UDI	Class III	Active
Heartmate®, System Monitor To Power Module Cable	103859	FDA UDI	Class III	Active
Thoratec® Heartmate® Xve And Heartmate Ii®, Apical Sewing Ring	1065	FDA UDI	Class III	Active
Explant Return Kit	28717	FDA UDI	Class III	Active
Heartmate®, Data Card	101609	FDA UDI	Class III	Active
HeartMate™	107754	FDA UDI	Class III	Active
HeartMate 3™	10002222US	FDA UDI	Class III	Active
HeartMate II®, System Controller	10005080	FDA UDI	Class III	Active
Thoratec® Heartmate Ii®, Skin Coring Punch	105557	FDA UDI	Class III	Active
Thoratec® Heartmate® Gogear®, Holster Vest, Small	104229	FDA UDI	Class III	Active
Thoratec® Pvad™, Arterial Cannula - Long, Straight, 18mm Graft	14812-2556-000	FDA UDI	Class III	Active
Thoratec® HeartMate® ICU Cover (6 Pack)	10002151	FDA UDI	Class III	Active
HeartMate, 14v Li-Ion Battery (SING)	102515-SING	FDA UDI	Class III	Unknown
Heartmate®, Mobile Power Unit, Ac Power Cord, Na	107760	FDA UDI	Class III	Active
External Pressure And Vacuum Connector Set	10025-2585-000	FDA UDI	Class III	Active
Thoratec® Heartmate® Gogear®, Modular Belt, Small-Medium	104220	FDA UDI	Class III	Active
Thoratec® Hearmate Ii®, Lvas Implant Kit(with Sealed Grafts)	106015Y	FDA UDI	Class III	Active
Thoratec® Heartmate Ii®, Sealed Outflow Short Bend Relief, 7.6cm (3 In)	104692	FDA UDI	Class III	Active
Thoratec® HeartMate 3™	10005877	FDA UDI	Class III	Active
Thoratec® Pvad™, Atrial Cannula - Long, Beveled Tip With Side Holes	10075-2573-001	FDA UDI	Class III	Active
Thoratec® Heartmate Ii®, Pump And Controller Only Kit	105903	FDA UDI	Class III	Active
Thoratec® HeartMate 3™ Modular Cable Cap	106526US	FDA UDI	Class III	Active
Thoratec® Heartmate Ii®, Outflow Cannula Bend Relief, 7.6 Cm (3 In)	102781	FDA UDI	Class III	Active
HeartMate 3™	10005872	FDA UDI	Class III	Active
HeartMate®, 14V Li-ion Rechargeable Battery Set	2465-US	FDA UDI	Class III	Active
HeartMate™	2365	FDA UDI	Class III	Active
HeartMate® Sealed Lead Acid Battery	109200	FDA UDI	Class III	Active
HeartMate® Power Module	103286	FDA UDI	Class III	Active
Heartmate®, Mobile Power Unit, Na	107754	FDA UDI	Class III	Active
Thoratec® Pvad™ And Ivad™, Tlc-Ii Wireless Adapter	105410	FDA UDI	Class III	Active
Thoratec® Heartmate® Gogear®, Wearable Accessories Kit	106129	FDA UDI	Class III	Active
Vad Driver Domestic	10025-2600-005	FDA UDI	Class III	Active
HeartMate® Universal Battery Charger	108701	FDA UDI	Class III	Active
Thoratec® Heartmate Ii®, Thread Protector Set	105558	FDA UDI	Class III	Active
Vectra®, Vascular Access Graft	10002-5040-001	FDA UDI	Class II	Active
Thoratec® One Tunneler Assembly Full Curve, With One Extra Tip And Sheath	10002-6003-001	FDA UDI	Class II	Active
Thoratec® Heartmate® Gogear®, Holster Vest, Large	104219	FDA UDI	Class III	Active
Thoratec® HeartMate 3™ Surgical Accessories Spares Kit	10006827	FDA UDI	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.