Thoratec Corp.

THORATEC CORP.

FDA registration

THORATEC CORP.·11 products·🇺🇸 United States

THORATEC CORP

FDA registration

THORATEC CORP·10 products·🇺🇸 United States

THORATEC

FDA Adverse Event

Injury ·THERMOCARDIO SYSTEMS, INC.·Product code DSQ·October 3, 2001

THORATECH LABORATORIES

FDA Adverse Event

Death ·THORATECH LABORATORIES·Product code DSQ·January 23, 1997

THORATEC CORP

FDA Adverse Event

Death ·THORATEC CORP.·Product code DSQ·September 18, 2014

THORATEC CORP

FDA Adverse Event

Injury ·THORATEC CORP·Product code DSQ·April 29, 2008

HEARTMATE

FDA Adverse Event

Malfunction ·THORATEC·Product code DSQ·March 12, 2003

HEARTMATE II LVAS

FDA Adverse Event

Injury ·THORATEC CORPORATION·Product code DSQ·January 7, 2013

THORATEC LABORATORIES CORP.

FDA Adverse Event

Injury ·THORATEC LABORATORIES CORP.·Product code DSQ·May 25, 1999

HEARTMATE II POCKET CONTROLLER

FDA Adverse Event

Malfunction ·THORATEC CORP.·Product code DSQ·July 10, 2014

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

FDA Enforcement

Class I ·Ongoing·Thoratec Corp.·June 19, 2024

Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

FDA Enforcement

Class I ·Ongoing·Thoratec Corp.·May 8, 2024

Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly

FDA Enforcement

Class I ·Ongoing·Thoratec Corp.·May 8, 2024

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 and will provide a user interface with state-of-the-art hardware/software platforms for supporting LVAD patients. Along with being able to program and monitor the LVAS, the HeartMate Touch Application introduces features that enables users to setup pairing and connection with the existing HeartMate 3 Left Ventricular Assist System (LVAS) via the HeartMate Touch Wireless Adapter and generate reports from the log files that are downloaded from the HM3 System Controller.

FDA Enforcement

Class I ·Ongoing·Thoratec Corp.·February 14, 2024

Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Rental US), HMT1150 (EU)

FDA Enforcement

Class II ·Ongoing·Thoratec Corp.·December 8, 2021

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, US 3. HeartMate 3 Sealed Outflow Graft with Bend Relief, OUS 4. HeartMate 3 LVAS Implant Kit, IDE 5. HeartMate 3 LVAS Implant Kit, US 6. HeartMate 3 LVAS Implant Kit, OUS HeartMate 3 Left Ventricular Assist System: The HeartMate 3 LVAS is designed to provide therapeutic benefit to those affected with advanced heart failure. The LVAS assumes some or all of the workload of the left ventricle. The LVAS features a Left Ventricular Assist Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus supporting equipment.

FDA Enforcement

Class I ·Ongoing·Thoratec Corp.·March 27, 2024

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 (February 14, 2024) HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II LVAS Implant Kit, OUS REF 102139 2. HeartMate II LVAS Implant Kit, US REF 1355 3. HeartMate II LVAS Implant Kit (with RSOC Controller), US REF 103695 4. HeartMate II LVAS Implant Kit (with RSOC Controller), OUS REF 103693 5. HeartMate II LVAS Implant Kit (with Sealed Graft), US REF 104911 6. HeartMate II LVAS Implant Kit (with Sealed Graft), OUS REF 104912 7. HeartMate II LVAS Implant Kit (Used for pump exchange, No Graft) REF 107801 8. HeartMate II LVAS Implant Kit, (EPC), CANADA REF 103695-CAN 9. HeartMate II LVAS Implant Kit (with Sealed Graft), JAPAN REF 104911JPN 10. HeartMate II LVAS Implant Kit (with Pocket System Controller and Sealed Grafts), for geographies outside of US & EU REF 106515OUS HeartMate II Left Ventricular Assist System: The HeartMate II LVAS is an axial-flow, rotary ventricular assist system. One end of the Left Ventricular Assist Device is attached to the apex of the left ventricle; the other end of the device connects to the ascending aorta. The Left Ventricular Assist Device diverts blood from the weakened left ventricle and propels it to the aorta. A small external computer, the System Controller, monitors system operation. A driveline, which passes through the patient s abdomen, connects the implanted pump to the System Controller. The system is powered by a Power Module or Mobile Power Unit (MPU) that is connected to an AC electrical outlet, or by two HeartMate 14 Volt Lithium-Ion batteries.

FDA Enforcement

Class I ·Ongoing·Thoratec Corp.·March 27, 2024

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 HeartMate 3 Left Ventricular Assist System (LVAS). The Coring Tool provides a means to resect a plug of myocardium from the left ventricle, which allows for HeartMate 3 inflow cannula insertion.

FDA Enforcement

Class II ·Terminated·Thoratec Corp.·May 1, 2019

Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only, Left Ventricular Assist System

FDA Enforcement

Class II ·Terminated·Thoratec Corp.·August 28, 2019

Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile, REF 105581US/105581, RX only, Part of Left Ventricular Assist Device (LVAD) UDI: 00813024013266

FDA Enforcement

Class II ·Terminated·Thoratec Corp.·August 28, 2019