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Class 1 Recall: Thoratec Implantable Ventricular Assist Devices

Submitted by jrlaw on Mar 9th, 2009

Thoratec Corporation and The US Food and Drug Administration (FDA) notified healthcare professionals and patients of a Class I Recall of Thoratec Implantable Ventricular Assist Devices (IVADs) Driver, 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.

The recalled product is Thoratec Corporation Implantable Ventricular Assist Devices (IVAD) Driver, Catalog Number 10012-2555-001, serial numbers 488 or higher and manufactured and distributed from October 1, 2004 through October 22, 2007.

The affected IVADs were distributed to 87 hospitals throughout the United States and other countries. The serial number is located on the label of the sterile package and on the driveline’s ?Y- connector.?An implantable ventricular assist device is a mechanical pump that helps a person’s heart that is too weak to pump blood through the body. The IVAD is designed to provide sufficient blood flow to the damaged or diseased heart. It is sometimes referred to as a ?bridge to transplant? since it can help a patient survive until a heart transplant can be performed. This device is air-driven (pneumatic).

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. These air leaks are a result of sharp bending of the driveline at the connection to the pump. This could result in not enough blood flow to and from the heart.

This recall does not affect implanted IVADs.

Customers and patients with questions may call the company at 1-800-528-2577.