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U.S. Department of Health and Human Services

Safety

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Thoratec Paracorporeal Ventricular Assist System (PVAD)

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

[Posted July 27, 2007] Thoratec Corporation and FDA notified healthcare professionals and patients of a Class I Recall of Thoratec Paracorporeal Ventricular Assist System (PVAD), Model TLC-II, Catalog No. 14086-2550-000. 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 PVAD may contain a black collet (circular rim) that holds a rod-like piece in place (nut). This black collet and nut was intended to be used with a cannula (a small tube) of an older design that had a larger diameter. If this black collet and nut is used with the current design of cannula that has a smaller diameter, it can disconnect during use. Dispose of any expired original design cannula. Do not use the black collet and nut with any design VAD. Make sure that all current patients using PVADs are using the white collet nut that is packaged with the cannula. Patients may call Thoratec Corporation at 1-925-847-8600.

[July 26, 2007 - Recall Notice - FDA]