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All product recalls associated with Thoratec Corp..
Total Recalls
7
Past Year
0
Class I (Serious)
0
Most Recent
May 2024
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
System monitor screen may display atypical behavior: Overlapping screens/buttons, Frozen screen, Distorted text, blanks, or zeroes in place of values, Unresponsive buttons where the user is unable to initiate a command, which may lead to anxiety /inconvenience, hemodynamic compromise, extended surgical time, and Pump Stop command may be selected
Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff.
Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System.
Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System.
Due to software and controller systems that results in unexpected pump start or pump stop.
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 result in an extended procedure or surgical time while the backup coring knife is acquired.
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 interference may cause the system App to close or fail to open. Once Bluetooth adaptor is connected, barring disconnection, all functionality is unaffected; the device will continue to operate as expected.