Thoratec Corporation
FDA adverse event reports naming Thoratec Corporation as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: THORATEC CORPORATION.
- Total reports
- 70,098
- Deaths
- 14,212
- Injuries
- 32,336
- Malfunctions
- 23,513
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Ventricular (Assist) BypassDSQ69,895
- Control, Pump Speed, Cardiopulmonary BypassDWA65
- Pump, Blood, Cardiopulmonary Bypass, Non-Roller TypeKFM30
- Prosthesis, Vascular Graft, Of 6mm And Greater DiameterDSY28
- Oxygenator, Cardiopulmonary BypassDTZ25
- Blood Pump For Ecmo, Long-Term (> 6 Hours) UseQNR23
- Prosthesis, Vascular Graft, Of Less Then 6mm DiameterDYF12
- Ventricular Bypass (Assist) DeviceOKR8
- Product code MOYMOY4
- Catheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassDWF3
Recent recalls
- 2017-05-24TerminatedDevice Design
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 for use inside or outside the hospital.
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.
- 2017-05-24TerminatedDevice Design
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 heart failure; intended for use inside or outside the hospital.
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.
- 2017-05-24TerminatedDevice Design
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 heart failure; intended for use inside or outside the hospital.
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.
- 2014-03-21TerminatedDevice Design
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 pump blood adequately on its own.
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.
- 2014-03-21TerminatedDevice Design
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 sometimes called a a heart pump or VAD. HeartMate II is a small implantable LVAD. HeartMate II attaches to the heart and is designed to assist or take over the pumping function of the patients left ventricle, the main pumping chamber of the heart.
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.
- 2014-03-21TerminatedDevice Design
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 adequately on its own.
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.
- 2014-03-21TerminatedDevice Design
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 its own.
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.
- 2012-03-23TerminatedDevice Design
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 of the HM II LVAS Implant Kit with Sealed Grafts. A short configuration of the HM II LVAS Sealed Outflow Graft Bend Relief is provided as a stand-along product. Thoratec Corporation 6035 Stoneridge Drive Pleasanton, CA 94588. Product Usage: The HM II LVAS is intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; either for temporary support, such as a bridge to Cardiac Transplanation or myocardial recovery, or as permanent destination therapy. The HeartMate II is intended for use inside or outside the hospital. The outflow of the HM II LVAS blood pump is connected to the aorta with a flexible vascular graft. The outflow graft is provided with a bend relief, a three or four in long tube of reinforced ePTFE surrounding the outflow graft proximal to the pump that is designed to prevent kinking of the outflow graft.
A trend of disconnected bend reliefs on the sealed outflow graft used with the HeartMate II LVAS has been identified
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