Class 1 Recall: Thoratec Corporation Implantable Ventricular Assist Devices (IVAD)

October 19, 2007

Thoratec Corporation Implantable Ventricular Assist Devices (IVAD), 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.

On October 19, 2007, Thoratec Corporation sent an Urgent Medical Device Correction notice to all of its customers notifying them of the problem. This notice also included new instructions regarding placement and care of the IVAD driveline.

Doctors should contact their patients if any Thoratec IVAD was placed in the external position. If patients have any questions, they should contact their doctor.

For more information about this recall, please see the company’s press release at:

http://phx.corporate-ir.net/phoenix.zhtml?c=95989&p=irol-newsArticle&ID=1074762&highlight=

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

• Online:www.fda.gov/MedWatch/report.htm
• Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm
  Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
• FAX: 1-800-FDA-0178