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URGENT Thoratec Corporation Worldwide Recall of Implantable Ventricular Assist Device
Date:11/8/2007

from approximately 45 IVADs placed in the paracorporeal position.

Until further notice, Thoratec is voluntarily advising that IVADs not be placed in the paracorporeal position, pending evaluation of any measures needed to prevent additional incidents of this type. Patients who are currently being supported by a Thoratec IVAD placed in the paracorporeal position (i.e. an external pump supporting blood circulation) should immediately contact their doctor. Your doctor will be able to determine if the driveline is properly positioned to minimize the amount of sharp bending. Hospitals were requested in the October 19, 2007 Recall Notification Letter to evaluate the driveline adjacent to the pump housing to ensure that it is not subject to extreme flexing or bending at acute angles on all patients currently on paracorporeal IVAD support. Hospitals having ongoing patients with IVADs in the paracorporeal position should contact Thoratec for further instructions if they did not receive the October 19, 2007 Recall Notification Letter. Copies of this press release may be found on Thoratec's website, http://www.thoratec.com, under Investor Relations/Press Releases.

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

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

* Online: http://www.fda.gov/medwatch/report.htm

* Regular Mail: use postage-paid FDA form 3500 available at:

http://www.fda.gov/MedWatch/getforms.htm.

Mail to MedWatch 5600 Fishers Lane, Rockville, MD

20852-9787

* Fax: 1-800-FDA-0178


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SOURCE Thoratec Corporation
Copyright©2007 PR Newswire.
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