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U.S. Department of Health and Human Services

Safety

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Thoratec TLC-II Portable Ventricular Assist Device (VAD) Driver

Audience: Cardiologists, hospital administrators, healthcare professionals, and patients

[Posted July 27, 2007] Thoratec Corporation and FDA notified healthcare professionals and consumers of a Class I Recall of Thoratec TLC-II Portable Ventricular Assist Device (VAD) Driver, Catalog No. 20010-0000-032. A Ventricular assist device is a mechanical pump that helps a person's heart that is 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 due to earlier than expected wear-out of the compressor motor (much less than the expected 3000 hours). The compressor motor can stop without warning. When the motor fails, there is a loss of VAD support for the patient, which results in inadequate blood flow to and from the heart. Check the current number of service hours on all units. Do not use the TLC-II drivers exceeding 1500 hours until they are serviced by Thoratec. 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. Patients should replace all drivers at 1500 hours and go back to the hospital for a new backup replacement. Patients may call the company at 1-925-847-8600.

[July 26, 2007 - Recall Notice - FDA]