Friday, November 16, 2007

Thoratec Implantable Ventricular Assist Device Recall

Thoratec Corporation and FDA have notified healthcare professionals and patients of a 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. If you have been injured by this product, please contact me immediately.

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.

Read the complete 2007 MedWatch safety summary including a link to the FDA Class 1 Recall notice regarding this issue at:

FDA Thoratec Implantable Ventricular Assist Device Recall Report