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www.fdanews.com/articles/96447-fda-announces-class-i-recall-of-thoratec-device

FDA Announces Class I Recall of Thoratec Device

July 27, 2007

The FDA announced a Class I Recall of Thoratec’s TLC-II Portable Ventricular Assist Device (VAD) Driver.

A Ventricular assist device is a mechanical pump to assist hearts too weak to pump blood through the body. The VAD is designed to provide sufficient blood flow to the damaged or diseased heart.

The product was recalled because the VAD support for the patient’s circulatory system may fail. The VAD driver may stop without warning due to earlier than expected wear-out of the compressor motor.

The complete MedWatch 2007 Safety Summary, including a link to the manufacturer’s recall notice, can be seen at www.fda.gov/medwatch/safety/2007/safety07.htm#TLCII