Company ยท US
Thoratec Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 2013 to 2015. Name variants (Inc, Corp, punctuation) are merged.
3510(k) clearances (0 in 12 months)
43recalls (8 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 18, 2015 | K152190 | Thoratec CentriMag Drainage (Venous) Cannula Kit Thoratec Corporation | DWF |
| Sep 18, 2015 | K152161 | Thoratec CentriMag Return (Arterial) Cannula Kit Thoratec Corporation | DWF |
| Jul 18, 2013 | K131179 | CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR Thoratec Corp | DWA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 18, 2026 | Thoratec LLC Brand Name: HeartMate
Product Name: HM 11V Li-ion Backup Battery, ABT
Model/Catalog Number: 106128
Software Version: N/A
Product Description: The HeartMate 11 Volt Lithium Ion Standalone Backup Batter Open, Classified |
DSQ | None listed |
| Jun 18, 2026 | Thoratec LLC Brand Name: HeartMate
Product Name: HeartMate 3" System Controller
Model/Catalog Number: 106531US
Software Version: N/A
Product Description: The HeartMate 3" System Controller acts as the central powe Open, Classified |
DSQ | None listed |
| Jun 18, 2026 | Thoratec LLC 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 S Open, Classified |
DSQ | None listed |
| Jan 15, 2026 | Thoratec LLC 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, 201-9 Open, Classified |
QNR | K222038 |
| Nov 14, 2025 | Thoratec LLC Brand Name: HeartMate
Product Name: HeartMate II Controller (standalone)
Model/Catalog Number: 106017, HeartMate II Pocket Controller, US; 106762, HeartMate II Pocket Controller, US; 107801, HeartMate Open, Classified |
DSQ | None listed |
| Nov 14, 2025 | Thoratec LLC Brand Name: HeartMate
Product Name: HeartMate II LVAS Implant Kit
Model/Catalog Number: 106015, HeartMate II LVAS Kit, with Pocket Controller, Sealed, US; 106016, HeartMate II LVAS Kit, with Pocket Co Open, Classified |
DSQ | None listed |
| Nov 14, 2025 | Thoratec LLC Brand Name: HeartMate
Product Name: HeartMate 3 Controller (Standalone)
Model/Catalog Number: 106531US, HeartMate 3 Controller, US; 106531INT, HeartMate 3 Controller, OUS; 106531LF2, HeartMate 3 Low F Open, Classified |
DSQ | None listed |
| Nov 14, 2025 | Thoratec LLC 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 Vers Open, Classified |
DSQ | None listed |
| Aug 13, 2025 | Thoratec LLC Brand Name: HeartMate
Product Name: Mobile Power Unit
Model/Catalog Number: 107754
Software Version: N/A
Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS) is a set of equipme Open, Classified |
DSQ | None listed |
| Aug 13, 2025 | Thoratec LLC 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 Open, Classified |
DSQ | None listed |
| Apr 17, 2025 | Thoratec LLC 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. Open, Classified |
DSQ | None listed |
| Aug 13, 2024 | Thoratec LLC 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: 106524 Open, Classified |
DSQ | None listed |
| Jun 7, 2024 | Thoratec Corp. 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 Open, Classified |
DSQ | None listed |
| May 1, 2024 | Thoratec Corp. Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly Open, Classified |
DSQ | None listed |
| May 1, 2024 | Thoratec Corp. Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly Open, Classified |
DSQ | None listed |
| Mar 22, 2024 | Thoratec Corp. HeartMate 3 Left Ventricular Assist System (LVAS):
1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE)
2. HeartMate 3 Sealed Outflow Graft with Bend Relief, Open, Classified |
DSQ | None listed |
| Mar 22, 2024 | Thoratec Corp. 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 Open, Classified |
DSQ | None listed |
| Feb 2, 2024 | Thoratec Corp. 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 Open, Classified |
DSQ | None listed |
| Sep 29, 2023 | Thoratec Corp. Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & HeartMate II Apical Coring Knife, REF: 1050 Open, Classified |
DSQ | None listed |
| Oct 22, 2021 | Thoratec Corp. Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Rental US), HMT1150 (EU) Open, Classified |
DSQ | None listed |
| Dec 2, 2019 | Thoratec Corp. 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 Terminated |
DSQ | None listed |
| Apr 19, 2019 | Thoratec Corp. 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 inten Terminated |
DSQ | None listed |
| Mar 30, 2019 | Thoratec Corp. Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile, REF 105581US/105581, RX only, Part of Left Ventricular Assist Device (LVAD) UDI: 00813024013266 Terminated |
DSQ | None listed |
| Mar 30, 2019 | Thoratec Corp. Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only, Left Ventricular Assist System Terminated |
DSQ | None listed |
| May 24, 2017 | Thoratec Corporation HeartMate II LVAS with Pocket Controller;
106762 - HMII POCKET CONTROLLER, NA;
UDI: 00813024011286
Intended to provide hemodynamic support in patients with end-stage, refractory left ventricular hea Terminated |
DSQ | None listed |
| May 24, 2017 | Thoratec Corporation HeartMate II LVAS with Pocket Controller;
106015 - HMII LVAD SEALED KIT-PCTRL, NA
UDI: 00813024011224
Intended to provide hemodynamic support in patients with end-stage, refractory left ventricular Terminated |
DSQ | None listed |
| May 24, 2017 | Thoratec Corporation 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 hea Terminated |
DSQ | None listed |
| Mar 21, 2014 | Thoratec Corporation Heart Mate II Pocket Controllers removed from packaging
Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequat Terminated |
DSQ | None listed |
| Mar 21, 2014 | Thoratec Corporation HeartMate II LVAD Pump and Pock Controller Kit;
Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on i Terminated |
DSQ | None listed |
| Mar 21, 2014 | Thoratec Corporation HeartMate II System Controller
Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own. It is some Terminated |
DSQ | None listed |
| Mar 21, 2014 | Thoratec Corporation 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 th Terminated |
DSQ | None listed |
| Mar 23, 2012 | Thoratec Corporation 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 t Terminated |
DSQ | None listed |
| Oct 13, 2010 | Thoratec Corp 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/ Terminated |
DSQ | None listed |
| Nov 24, 2009 | Thoratec Corp 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 LV Terminated |
DSQ | None listed |
| Dec 22, 2008 | Thoratec Corp 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. Terminated |
DSQ | None listed |
| Nov 21, 2007 | Thoratec Corp 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 Terminated |
DSQ | None listed |
| Jul 27, 2007 | Thoratec Corp Thoratec Paracorporeal Ventricular Assist Device (PVAD) component of the Thoratec VAD system. Catalog number 14086-2550-000. Terminated |
DSQ | None listed |
| Jul 27, 2007 | Thoratec Corp Thoratec TLC-II Portable VAD Driver. Component (pneumatic) driver of Thoratec Ventricular Assist Device system Terminated |
DSQ | None listed |
| Feb 10, 2007 | Thoratec Corp 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, Ple Terminated |
DSQ | None listed |
| Oct 4, 2006 | Thoratec Corp 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;
#10012 Terminated |
DSQ | None listed |
| Oct 3, 2006 | Thoratec Corp 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 Terminated |
DSQ | None listed |
| Mar 27, 2003 | Thoratec Corp HeartMate Stroke Volume Limiter (SVL)
Catalog # 1295 Terminated |
DSQ | None listed |
| Jan 30, 2003 | Thoratec Corp Thoratec Sterile LVAD Pneumatic Lead 5'' ;
Model/Product Number: 20010-0000-108 Terminated |
DSQ | None listed |