Thoratec
18 federal recalls on file, showing the 7 from the last 12 months. We monitor every CPSC, FDA, USDA, and NHTSA notice for Thoratec and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-06-24FDA-DeviceClass IIThoratec HeartMate backup battery recalled for failure risk
The HeartMate 11 Volt Lithium Ion Backup Battery, a critical component of the HeartMate 3 System Controller, can fail to provide emergency power when needed. The backup battery is designed to supply at least 15 minutes of emergency power if the main power source fails. Battery failures could prevent the system controller from operating during power loss.
- 2026-06-24FDA-DeviceClass IIHeartMate 3 System Controller recalled for backup battery failures
The HeartMate 3 System Controller, which powers and monitors left ventricular assist devices (LVADs), may experience failures in its 11-volt backup battery. This backup battery is critical for emergency power when other power sources are unavailable.
- 2026-01-21FDA-DeviceClass IICheck Thoratec CentriMag Blood Pump serial numbers
Thoratec CentriMag blood pump components used in acute circulatory support and ECMO systems may not lock securely into the motor. If the pump fails to lock properly, the system may not generate an alarm, which could delay critical heart support or cause serious complications.
- 2025-11-26FDA-DeviceClass IIBrand 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 II¿ Pocket Controller Software Version: N/A Product Description: The HeartMate II System Controller is a small computer that controls and monitors system operation. It sends power and operating signals to the Left Ventricular Assist Device and adjusts device operation to maintain programme
Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
- 2025-11-26FDA-DeviceClass IIBrand 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 Controller, Sealed, EU Software Version: N/A Product Description: The HeartMate II LVAS is an axial-flow, rotary ventricular assist system that generates flows up to 10 liters per minute (lpm). One end of the Left Ventricular Assist Device is attached to the apex of the left ventricle; the othe
Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
- 2025-11-26FDA-DeviceClass IIBrand 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 Flow 2.0 Controller Software Version: N/A Product Description: The HeartMate 3" System Controller acts as the central power and communication hub for the HeartMate 3 LVAS. It passes power from the Power Module, the Mobile Power Unit, Lithium-Ion Batteries, or its own integrated emergency backup s
Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
- 2025-11-26FDA-DeviceClass IIBrand 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 Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS) is a set of equipment and materials that together comprise a medical device designed to provide therapeutic benefit to those affected with advanced heart failure. In service, the LVAS assumes some or all of the
Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
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