Thoratec Corp. recalls
17 recalls in our records from 2014 to 2026: 17 FDA medical devices.
Recalls with full detail pages
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Thoratec LLC medical device recall: Brand Name: HeartMate Product Name: Mobile Power Unit
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…
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Thoratec LLC medical device recall: HeartMate Mobile Power Unit: REF: 107754
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,…
Earlier and other recalls
These link to the official agency notice.
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Thoratec LLC medical device recall: Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular… Official notice ↗
Due to 11 volt Backup Battery failures.
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Thoratec LLC medical device recall: CentriMag Blood Pump Official notice ↗
Acute circulatory support system pump may not fit into the motor and reports received of the pump not being securely locked into the motor using the screw-in locking…
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Thoratec LLC medical device recall: Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular… Official notice ↗
Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
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Thoratec LLC medical device recall: HeartMate 3 System Controllers provided within the following… Official notice ↗
Left ventricular assist system controller UI membrane/screen may lift along the edge of the controller housing, and if controller is exposed to fluid, ingress may occur,…
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Thoratec Corp. medical device recall: Thoratec HeartMate System Monitor Official notice ↗
System monitor screen may display atypical behavior: Overlapping screens/buttons, Frozen screen, Distorted text, blanks, or zeroes in place of values, Unresponsive…
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Thoratec Corp. medical device recall: Thoratec HeartMate 3 Official notice ↗
Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff.
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Thoratec Corp. medical device recall: HeartMate II Left Ventricular Assist System Official notice ↗
Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System.
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Thoratec Corp. medical device recall: 1. HeartMate Touch Communication System Official notice ↗
Due to software and controller systems that results in unexpected pump start or pump stop.
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Thoratec Corp. medical device recall: Heartmate 3 LVAS Implant Kit Official notice ↗
Inability to start and/or complete the coring procedure due to inadequate sharpness of the Apical Coring Knife, provided with Left Ventricular Assist System, could…
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Thoratec Corp. medical device recall: Abbott HeartMate Touch Communication System Official notice ↗
If LVAS communication system is trying to establish Bluetooth connection and another Bluetooth-enabled device is nearby and advertising for Bluetooth connection, the…
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Thoratec Corp. medical device recall: HeartMate 3 Mobile Power Unit Official notice ↗
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…
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Thoratec Corp. medical device recall: Thoratec HeartMate 3 LVAS Implant Kit Official notice ↗
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…
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Thoratec Corp. medical device recall: Thoratec HeartMate 3 Coring Tool Official notice ↗
Small black plastic particle was observed in the left ventricle during implant procedure.
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Thoratec Corporation medical device recall: HeartMate¿ II LVAS with Pocket Controller Official notice ↗
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…
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Thoratec Corporation medical device recall: HeartMate II Implant Kit with Pocket Controller Official notice ↗
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…
Firm names are matched across agencies by name only. Different companies with similar names may be grouped together; check each official notice.