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Jenny Albano
Jenny Albano
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Class 1 Recall of Thoratec TLC-II Portable Ventricular Assist Device (VAD) Driver

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The Thoratec TLC-II Portable Ventricular Assist Device (VAD) Driver has been recalled by the FDA and the Thoratec Corporation because the VAD support for the patient’s circulatory system may fail. A Ventricular assist device is a mechanical pump that assists a person’s heart that is too weak to pump blood throughout the body itself. The VAD is used to give sufficient blood flow to the damaged heart.

The VAD driver may stop becasue of an early and unexpected wear-out of the compressor motor. The compressor motor may stop without a warning. If and when the motor fails, the VAD loses support for the patient’s blood flow, which can cause the patient’s circulatory system to fail.

The VAD drivers are not to be used past 1,500 hours until the company has serviced them.

Doctors should ensure that all patients have a back-up driver and hand pumps at all times and have been trained in backup procedures. When the 1500 hour limit has been reached, patients must stop using the device and send it to the manufacturer for servicing.

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