Data / Medical devices / United States / Thoratec Corp.
Thoratec Corp.: FDA-registered device maker in Pleasanton, CA, United States, 6 510(k) clearances and 4 PMA approvals
Thoratec Corp. is registered with the FDA (registration 2916596) in Pleasanton, CA, United States. It lists 11 device types. The FDA files 6 510(k) clearances and 4 PMA approvals under its listings, the newest dated January 26, 2024. 30 recall events name it as the recalling firm (9 Class I). Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2916596
- Address
- 6035 Stoneridge Dr, Pleasanton, CA, United States, 94588
- Owner or operator
- ABBOTT LABORATORIES (1415939)
- Roles
- Manufacturer, Specification developer
- First device listed
- February 12, 2018
- Registered through
- 2027
- Brand names listed
- 2nd Generation CentriMag Primary Console and Monitor, CIRCULAR OXYGENATOR BRACKET LARGE, CIRCULAR OXYGENATOR BRACKET MEDIUM, CIRCULAR OXYGENATOR BRACKET SMALL, CardioMEMS HERO Device, CardioMEMS HF System, CardioMEMS Hospital Electronics System, CardioMEMS Hospital System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory Equipment, Cardiopulmonary Bypass | KRI | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Blood Pump For Ecmo, Long-Term (> 6 Hours) Use | QNR | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | DWF | 2 | Manufacturer | accessdata.fda.gov |
| Console, Heart-Lung Machine, Cardiopulmonary Bypass | DTQ | 2 | Manufacturer | accessdata.fda.gov |
| Control, Pump Speed, Cardiopulmonary Bypass | DWA | 2 | Manufacturer | accessdata.fda.gov |
| Heat-Exchanger, Cardiopulmonary Bypass | DTR | 2 | Manufacturer | accessdata.fda.gov |
| Oxygenator, Cardiopulmonary Bypass | DTZ | 2 | Manufacturer | accessdata.fda.gov |
| Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | KFM | 2 | Manufacturer | accessdata.fda.gov |
| Right Ventricular Bypass (Assist) Device | OJE | f | Manufacturer | accessdata.fda.gov |
| System, Hemodynamic, Implantable | MOM | 3 | Manufacturer | accessdata.fda.gov |
| Ventricular (Assist) Bypass | DSQ | 3 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 26, 2024 | K234118 | CentriMag Acute Circulatory Support System | QNR | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| December 8, 2022 | K222038 | CentriMag Blood Pump for use with CentriMag Acute Circulatory Support System | QNR | Substantially Equivalent | Abbott (Formerly Thoratec Corporation) | accessdata.fda.gov |
| December 1, 2022 | K222297 | CentriMag Pre-connected Pack | DTZ | Substantially Equivalent | Abbott | accessdata.fda.gov |
| August 27, 2010 | K102129 | LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR | DWA | Substantially Equivalent | Levitronix, LLC | accessdata.fda.gov |
| October 8, 2009 | K090051 | LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052 | KFM | Substantially Equivalent | Levitronix, LLC | accessdata.fda.gov |
| March 25, 2003 | K020271 | LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100 | KFM | Substantially Equivalent | Levitronix, LLC | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| December 6, 2019 | P170038 | CentriMag Circulatory Support System | DSQ | 32 | October 2, 2026 | accessdata.fda.gov |
| August 23, 2017 | P160054 | HeartMate 3 Left Ventricular Assist System | DSQ | 132 | October 19, 2026 | accessdata.fda.gov |
| May 28, 2014 | P100045 | CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM | MOM | 90 | September 30, 2026 | accessdata.fda.gov |
| April 21, 2008 | P060040 | THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM | DSQ | 125 | October 1, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 13, 2026 | 99023 | Class II | Ongoing | Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS) is a se | Due to 11 volt Backup Battery failures. | accessdata.fda.gov |
| October 10, 2025 | 97784 | Class II | Ongoing | CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMag RVAD HDE KIT, REF: 104318; CentriMag Pre-connected Pack, REF: CMAEK00; CentriMag VAD KIT, REF: 201-51006, 201-51007, 201-90001 201-90001T; Blo | 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 suppo | accessdata.fda.gov |
| October 9, 2025 | 97782 | Class II | Ongoing | Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US, HeartMate 3 LVAS KIT, US; 106524INT, HeartMate 3 LVAD KIT, OUS; 106524 Software Version: N/A Product Des | Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm. | accessdata.fda.gov |
| June 23, 2025 | 97256 | Class I | Ongoing | Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/Catalog Number: 107760 Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS) is a set of equipment an | 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. | accessdata.fda.gov |
| March 13, 2025 | 96471 | Class I | Ongoing | HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 107758UK, UK; L107758, EU Rental. Used with HeartMate 3 and II Left Ventricular Assist System. | 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 recharg | accessdata.fda.gov |
| June 25, 2024 | 94973 | Class II | Ongoing | HeartMate 3 System Controllers provided within the following HeartMate 3 Left Ventricular Assist System (LVAS) Implant Kits or distributed separately: HeartMate 3 LVAS Implant Kit, US, Model: 106524US; HeartMate 3 LVAS I | 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 al | accessdata.fda.gov |
| May 8, 2024 | 94478 | Class I | Ongoing | Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US, L1286A-US, 1286C, L1286C, L1386, 1286A-CAN, 1286INT and L1286INT. Left ventricular assist device | 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 | accessdata.fda.gov |
| March 1, 2024 | 94232 | Class I | Ongoing | Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly | Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff. | accessdata.fda.gov |
| February 19, 2024 | 93963 | Class I | Ongoing | HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed Outflow Graft with Bend Relief REF 103393 2. HeartMate II LVAS Implant Kit, US REF 106015 3. HeartMate II LVAS Implant Kit, OUS REF 106016 Update | Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System. | accessdata.fda.gov |
| January 3, 2024 | 93697 | Class I | Ongoing | 1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3. HeartMate Touch Communication System, HMT1150 The HeartMate Touch Application is loaded onto a tablet | Due to software and controller systems that results in unexpected pump start or pump stop. | accessdata.fda.gov |
| August 7, 2023 | 92951 | Class II | Ongoing | Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & HeartMate II Apical Coring Knife, REF: 1050 | 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. | accessdata.fda.gov |
| October 22, 2021 | 88876 | Class II | Ongoing | Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Rental US), HMT1150 (EU) | 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 wil | accessdata.fda.gov |
| December 2, 2019 | 84379 | Class II | Terminated | HeartMate 3 Mobile Power Unit, REF 107754, UDI or GTIN: 00813024010883, and 107758, UDI or GTIN: 00813024010890, when connected to the HeartMate 3 Left Ventricular Assist System, REF 106524US, UDI or GTIN: 00813024013297 | 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. | accessdata.fda.gov |
| March 30, 2019 | 83357 | Class II | Terminated | Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only, Left Ventricular Assist System | 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. | accessdata.fda.gov |
| March 1, 2019 | 82458 | Class II | Terminated | Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an optional accessory of Thoratec HeartMate 3 Left Ventricular Assist System - Product Usage: The HeartMate 3 Coring Tool is intended for use with the | Small black plastic particle was observed in the left ventricle during implant procedure. | accessdata.fda.gov |
| April 5, 2018 | 79893 | Class I | Terminated | Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 Indicated for providing short-term hemodynamic support in patients with advanced refractory left ventricular heart fai | Reports of outflow graft twist occlusions. Patients whose devices experience outflow graft occlusions will experience a persistent low flow alarm. Outflow graft occlusions can result in serious adverse events such as hemodynamic compromise, thrombus, and death. | accessdata.fda.gov |
| March 30, 2017 | 76978 | Class I | Terminated | HeartMate II LVAS with Pocket Controller; 107801 - HMII PUMP & POCKET CTRL ONLY UDI:00813024011286 Intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; intended f | 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. | accessdata.fda.gov |
| March 4, 2014 | 67639 | Class I | Terminated | HeartMate II Implant Kit with Pocket Controller; with sealed grafts (NAm) with sealed grafts (EU) Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to | 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. | accessdata.fda.gov |
| February 23, 2012 | 61268 | Not yet classified | Terminated | HeartMate II Left Ventricular Assist System (HM II LVAS) Sealed Outflow Graft Bend Relief. The Sealed Outflow Graft Bend Relief is provided as a component of the HM II Sealed Outflow Graft, which in turn is a component o | A trend of disconnected bend reliefs on the sealed outflow graft used with the HeartMate II LVAS has been identified | accessdata.fda.gov |
| September 1, 2010 | 56694 | Not yet classified | Terminated | HeartMate II System Controller, a component of the HeartMate II Left Ventricular Device System (LVAS), distributed both as stand alone devices and as components of the LVAS Implant kit. Manufactured/Distributed by Thorat | Connection failure-- product may malfunction because of bent pins or broken wires in power cord connection | accessdata.fda.gov |
| October 14, 2009 | 53561 | Not yet classified | Terminated | HeartMate 12 volt sealed lead acid Battery Clips that are components of the HeartMate II LVAS (PMA P060040) and the HeartMate XVE LVAS (PMA P920014) Systems. The HeartMate II and the HeartMate XVE LVAS are intended for u | 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 X | accessdata.fda.gov |
| October 24, 2008 | 50091 | Not yet classified | Terminated | Thoratec Heartmate II Left Ventricular Assist System (LVAS). Model/Catalog Number 1355 and Model/Catalog Number 102139. Product is manufactured and distributed by Thoratec Corporation, Pleasant, CA. The HM II LVAS is int | 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. | accessdata.fda.gov |
| October 19, 2007 | 45486 | Not yet classified | Terminated | Thoratec Implantable Ventricular Assist Device (IVAD pump) (Component of Thoratec Ventricular Assist Device (VAD) System), Catalog No. 10012-2555-001,Thoratec Corporation, Pleasanton, CA. 94588 | 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). | accessdata.fda.gov |
| June 8, 2007 | 38325 | Not yet classified | Terminated | Thoratec TLC-II Portable VAD Driver. Component (pneumatic) driver of Thoratec Ventricular Assist Device system | 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. | accessdata.fda.gov |
| March 30, 2007 | 38342 | Not yet classified | Terminated | Thoratec Paracorporeal Ventricular Assist Device (PVAD) component of the Thoratec VAD system. Catalog number 14086-2550-000. | 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 | accessdata.fda.gov |
| August 25, 2006 | 36186 | Not yet classified | Terminated | Thoratec brand TLC-II Portable Ventricular Assist Device (VAD) Driver; Catalog No. 20010-2085-000 Distributed and Manufactured by Thoratec Corporation, 6035 Stoneridge Drive, Pleasanton, CA 94588 | Sticky Valve Disk- The valve disk has an increased tendency to stick during operation causing noise and pressure/vacuum alarms. | accessdata.fda.gov |
| September 24, 2004 | 36154 | Not yet classified | Terminated | Thoratec Dual Drive Console a drive component of the Thoratec Ventricular Assist Device, Model Numbers, 10025-2600-005, 10025-2601-007, 10025-2602-006, Thoratec Corporation, 6035 Stoneridge Drive, Pleasanton, CA 94588 | The module power switch (at the back of console) may break while attempting to turn the Dual Drive Console OFF or ON. | accessdata.fda.gov |
| January 26, 2004 | 36138 | Not yet classified | Terminated | Thoratec brand Sealed Arterial Cannula for use with the Thoratec Vascular Assist Device System, Model Number(s): Catalogue numbers: #100118-- Short, 14mm graft; #100121-- Long, 14mm graft; #100129-- Long, 18mm graft. Man | During use an unexpected flaking of the inner surface coating (blood contact) that has the potential for risk of embolism. | accessdata.fda.gov |
| February 7, 2003 | 25631 | Not yet classified | Terminated | HeartMate Stroke Volume Limiter (SVL) Catalog # 1295 | Driveline tubing connections on the SVL if under STRESS condition may snap off, VAD support is compromised, a serious injury or death can occur. | accessdata.fda.gov |
| December 16, 2002 | 25262 | Not yet classified | Terminated | Thoratec Sterile LVAD Pneumatic Lead 5''; Model/Product Number: 20010-0000-108 | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
- All makers of Accessory Equipment, Cardiopulmonary Bypass
- All makers of Ventricular (Assist) Bypass
- All makers of Control, Pump Speed, Cardiopulmonary Bypass
- All makers of Blood Pump For Ecmo, Long-Term (> 6 Hours) Use
- All makers of Right Ventricular Bypass (Assist) Device
Updated October 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.