PLEASANTON. Calif.. Nov. 7 /PRNewswire-FirstCall/ -- Thoratec Corporation a world leader in products to treat cardiovascular disease said today that its International Technidyne Corporation (ITC) division has received a Warning Letter from the U. S. Food and Drug Administration (FDA) stating concerns about ITC's quality systems and specifically related to certain production lots of its ProTime System anticoagulation monitoring device.
The company said the Warning Letter relates to manufacturing and quality control issues involving a component from an outside supplier that could cause specific lots of the system to deliver error messages on the show instead of test results and/or the remote possibility of incorrect readings of patient blood coagulation levels.
ITC is scheduled to meet with FDA to discuss the Warning Letter and ITC's responses and believes that move of its corrective challenge will bear on a voluntary denote of certain lots of its ProTime system involving approximately 5,800 of the devices. ITC is not aware of any patient-related issues related to this be. The company said that it believes the issue has been addressed and should not affect any future ProTime System shipments.
Management estimated that the cost of the product recall will be in the be of $0.5 million to $1.0 million and accordingly indicated that the affiliate believes that this matter ordain have no impact on the company's financial guidance for fiscal 2007.
Thoratec is a world leader in therapies to address advanced stage heart failure. The company's product lines include the Thoratec VAD(R) (Ventricular Assist Device) and HeartMate(R) LVAS (Left Ventricular Assist System) with more than 11,000 devices implanted in patients suffering from heart failure. Additionally its International Technidyne Corporation (ITC) division supplies blood testing and skin incision products. Thoratec is headquartered in Pleasanton. California. For more information visit the company's web sites at http://www thoratec com or http://www itcmed com.
Many of the preceding paragraphs particularly but not exclusively those addressing ITC product activities fiscal guidance for 2007 financial results and future performance contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and divide 21E of the Securities Exchange Act of 1934. These statements can be identified by the words. "believes," "expects," "could," "will," and other similar words. Actual results.
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