ClearanceBrief
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

CodeDeviceRecords
DSQVentricular (Assist) Bypass42
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass2
DWAControl, Pump Speed, Cardiopulmonary Bypass1
QNRBlood Pump For Ecmo, Long-Term (> 6 Hours) Use1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Sep 18, 2015K152190Thoratec CentriMag Drainage (Venous) Cannula Kit
Thoratec Corporation
DWF
Sep 18, 2015K152161Thoratec CentriMag Return (Arterial) Cannula Kit
Thoratec Corporation
DWF
Jul 18, 2013K131179CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR
Thoratec Corp
DWA

Latest recalls

DateFirm and productCodeLinked 510(k)
Jun 18, 2026Thoratec 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
DSQNone listed
Jun 18, 2026Thoratec 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
DSQNone listed
Jun 18, 2026Thoratec 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
DSQNone listed
Jan 15, 2026Thoratec 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
QNRK222038
Nov 14, 2025Thoratec 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
DSQNone listed
Nov 14, 2025Thoratec 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
DSQNone listed
Nov 14, 2025Thoratec 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
DSQNone listed
Nov 14, 2025Thoratec 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
DSQNone listed
Aug 13, 2025Thoratec 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
DSQNone listed
Aug 13, 2025Thoratec 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
DSQNone listed
Apr 17, 2025Thoratec 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
DSQNone listed
Aug 13, 2024Thoratec 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
DSQNone listed
Jun 7, 2024Thoratec 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
DSQNone listed
May 1, 2024Thoratec Corp.
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly
Open, Classified
DSQNone listed
May 1, 2024Thoratec Corp.
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
Open, Classified
DSQNone listed
Mar 22, 2024Thoratec 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
DSQNone listed
Mar 22, 2024Thoratec 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
DSQNone listed
Feb 2, 2024Thoratec 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
DSQNone listed
Sep 29, 2023Thoratec Corp.
Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & HeartMate II Apical Coring Knife, REF: 1050
Open, Classified
DSQNone listed
Oct 22, 2021Thoratec Corp.
Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Rental US), HMT1150 (EU)
Open, Classified
DSQNone listed
Dec 2, 2019Thoratec 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
DSQNone listed
Apr 19, 2019Thoratec 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
DSQNone listed
Mar 30, 2019Thoratec 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
DSQNone listed
Mar 30, 2019Thoratec Corp.
Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only, Left Ventricular Assist System
Terminated
DSQNone listed
May 24, 2017Thoratec 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
DSQNone listed
May 24, 2017Thoratec 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
DSQNone listed
May 24, 2017Thoratec 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
DSQNone listed
Mar 21, 2014Thoratec 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
DSQNone listed
Mar 21, 2014Thoratec 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
DSQNone listed
Mar 21, 2014Thoratec 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
DSQNone listed
Mar 21, 2014Thoratec 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
DSQNone listed
Mar 23, 2012Thoratec 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
DSQNone listed
Oct 13, 2010Thoratec 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
DSQNone listed
Nov 24, 2009Thoratec 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
DSQNone listed
Dec 22, 2008Thoratec 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
DSQNone listed
Nov 21, 2007Thoratec 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
DSQNone listed
Jul 27, 2007Thoratec Corp
Thoratec Paracorporeal Ventricular Assist Device (PVAD) component of the Thoratec VAD system. Catalog number 14086-2550-000.
Terminated
DSQNone listed
Jul 27, 2007Thoratec Corp
Thoratec TLC-II Portable VAD Driver. Component (pneumatic) driver of Thoratec Ventricular Assist Device system
Terminated
DSQNone listed
Feb 10, 2007Thoratec 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
DSQNone listed
Oct 4, 2006Thoratec 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
DSQNone listed
Oct 3, 2006Thoratec 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
DSQNone listed
Mar 27, 2003Thoratec Corp
HeartMate Stroke Volume Limiter (SVL) Catalog # 1295
Terminated
DSQNone listed
Jan 30, 2003Thoratec Corp
Thoratec Sterile LVAD Pneumatic Lead 5'' ; Model/Product Number: 20010-0000-108
Terminated
DSQNone listed
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