courtlistener_docket
2 records
Rodriguez v. Thoratec Corporation
2026-04-22
Federal docket 3:26-cv-01314 (txnd); matched party 'Thoratec Corporation'
View Source
Chevi Parker, Individually and on behalf of All Wrongful Death Beneficiaries, and on Behalf of the Estate of Laura Parker v. Thoratec, LLC
2026-04-13
Federal docket 5:26-cv-00075 (txnd); matched party 'Thoratec, LLC'
View Source
fda
22 records
FDA Device Recall: Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/
2025-11-26
Class II — Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
View Source
FDA Device Recall: Brand Name: HeartMate Product Name: HeartMate II¿ Controller (standalone) Mode
2025-11-26
Class II — Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
View Source
FDA Device Recall: Brand Name: HeartMate Product Name: HeartMate II¿ LVAS Implant Kit Model/Catal
2025-11-26
Class II — Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
View Source
FDA Device Recall: Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/Cat
2025-08-20
Class I — 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 disconn...
View Source
FDA Device Recall: HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 107758UK
2025-04-23
Class I — 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 cont...
View Source
FDA Recall: Thoratec Corp. — Class I
20240508
Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff. | Product: Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, S...
View Source
FDA Device Recall: Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
2024-05-08
Class I — Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff.
View Source
FDA Device Recall: HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflo
2024-03-27
Class I — Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System.
View Source
FDA Device Recall: HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed Outf
2024-03-27
Class I — Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System.
View Source
FDA Device Recall: 1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communi
2024-02-14
Class I — Due to software and controller systems that results in unexpected pump start or pump stop.
View Source
FDA Device Recall: Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Renta
2021-12-08
Class II — 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 ...
View Source
FDA Device Recall: HeartMate 3 Mobile Power Unit, REF 107754, UDI or GTIN: 00813024010883, and 1077
2020-01-08
Class II — 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 lea...
View Source
FDA Recall: Thoratec Corp. — Class II
20190828
Outflow Graft leaking at the pump connection during the implantation process. If the C-Ring is insufficiently seated, it renders the device nonfunctio | Product: Thoratec Heartmate 3 Sealed Outflow Gr...
View Source
FDA Recall: Thoratec Corp. — Class II
20190501
Small black plastic particle was observed in the left ventricle during implant procedure. | Product: Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an optional accessory of Thor...
View Source
FDA Device Recall: Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile, REF 105581U
2019-08-28
Class II — 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 connectio...
View Source
FDA Device Recall: Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only, Le
2019-08-28
Class II — 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 connectio...
View Source
FDA Device Recall: Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an optiona
2019-05-01
Class II — Small black plastic particle was observed in the left ventricle during implant procedure.
View Source
FDA Device Recall: HeartMate¿ II LVAS with Pocket Controller; 106762 - HMII POCKET CONTROLLER, NA
2017-05-31
Class I — 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 i...
View Source
FDA Device Recall: HeartMate¿ II LVAS with Pocket Controller; 107801 - HMII PUMP & POCKET CTRL ON
2017-05-31
Class I — 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 i...
View Source
FDA Device Recall: HeartMate II System Controller Product Usage: HeartMate II is a mechanical d
2014-04-02
Class I — 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 contr...
View Source
FDA Device Recall: HeartMate II LVAD Pump and Pock Controller Kit; Product Usage: HeartMate I
2014-04-02
Class I — 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 contr...
View Source
FDA Device Recall: Heart Mate II Pocket Controllers removed from packaging Product Usage: Hea
2014-04-02
Class I — 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 contr...
View Source
ftc_enforcement
4 records
Thoratec Corporation/HeartWare International, Inc.
2009-08-21
FTC live enforcement action FY2009; matched respondent 'Thoratec Corporation'
View Source
Thoratec Corporation, and HeartWare International, Inc., In the Matter of
2009-08-11
FTC live enforcement action FY2009; matched respondent 'Thoratec Corporation'
View Source
Thoratec Corporation / HeartWare International, Inc.
2009-07-30
FTC merger enforcement action FY2009 matter 910064; matched respondent 'Thoratec Corporation'
View Source
Thoratec Corporation/HeartWare International, Inc.
2009-06-26
FTC live enforcement action FY2009; matched respondent 'Thoratec Corporation'
View Source
nppes
1 records
ny_corps
1 records
NY Corp: THORATEC LLC
2016-11-15
FOREIGN LIMITED LIABILITY COMPANY | County: New York | Jurisdiction: California
View Source
Be informed when major changes happen on C.F.A.I. — new data sources, platform updates, critical enforcement alerts
No spam. Only major updates. Unsubscribe anytime.