FDA Recalls Thoratec TLC-II Portable Ventricular Assist Device Drivers

Lee Coleman

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A Class I recall of the Thoratec TLC-II Portable Ventricular Assist Device Drivers (VAD) drivers has been initiated due to earlier than expected compressor motor wear out. The wear out time expected was 3000 hours and anyone with drivers exceeding 1500 hours need to stop using the units until they can be serviced by Thoratec, they should take them back to the hospital for a new backup replacement. The device is to assist as a mechanical pump that helps a persons heart that is too weak to pump blood through the body, it helps to provide sufficient blood flow to the diseased or damaged heart.

For more information on this subject, please refer to our section on Drugs, Medical Devices, and Implants.