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U.S. Department of Health and Human Services

Safety

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Thoratec Implantable Ventricular Assist Devices

Audience: Cardiologists, hospital risk managers, patients

[Posted 11/16/2007] Thoratec Corporation and FDA notified healthcare professionals and patients of a Class I Recall of Thoratec Implantable Ventricular Assist Devices (IVADs), serial numbers 488 and higher (located on the label of the sterile package and on the driveline’s Y-connector), manufactured and distributed from October 1, 2004 through October 22, 2007. The device is a mechanical air-driven (pneumatic) pump that helps a person's heart that is too weak to pump blood through the body. The current instructions for use state that IVADs may be implanted or placed in the external position. If the IVAD is placed in the external position, air leaks may develop in the pneumatic driveline that could result in not enough blood flow to and from the heart. This recall does not affect implanted IVADs. Physicians should contact their patients if any Thoratec IVAD was placed in the external position and patients should contact their physicians with any questions.

[November 16, 2007 - Recall Notice - FDA]