PLEASANTON, Calif., April 4, 2012 /PRNewswire/ -- Thoratec Corporation (Nasdaq: THOR) today commented on a recent voluntary medical device correction notification (the "Notification"), related to the bend relief component for the sealed outflow graft of the HeartMate II® Left Ventricular Assist System. The company initiated the voluntary Notification to clinicians on February 23, 2012.
Following the company's voluntary Notification to clinicians on February 23, 2012, the FDA posted information regarding the action on its website during the week of March 19th. Today, this same information appeared in the news section of the FDA website. However, today's posting was only a reference to the previous communication, and there was no new information provided.
After initiating the Notification, Thoratec contacted all hospitals to whom HeartMate II sealed outflow grafts had been distributed. The company's voluntary Notification was intended to provide information to clinicians, including a clarification of the instructions for use, and did not involve the return of any product. Subsequently, the company received acknowledgment forms from surgeons at all such U.S. hospitals, verifying that clinicians have reviewed the Notification and understand the information provided.
Thoratec anticipates no material financial impact from this action.Thoratec, the Thoratec logo, HeartMate and HeartMate II are registered trademarks of Thoratec Corporation and IVAD is a trademark of Thoratec Corporation. CentriMag and PediMag are registered trademarks of Thoratec LLC, and PediVAS is a registered trademark of Thoratec Switzerland GmbH. Many of the preceding paragraphs, particularly but not exclusively those addressing future performance, contain forward-looking statements within the meaning of Sections 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements can be identified by the words, "anticipates," "believes," "views," "expects," "plans," "projects," "hopes," "could," "will," and other similar words. Actual results, events or performance could differ materially from these forward-looking statements based on a variety of factors, many of which are beyond Thoratec's control. Therefore, readers are cautioned not to put undue reliance on these statements. Investors are cautioned that all such statements involve risks and uncertainties. Forward-looking statements contained in this press release should be considered in light of these factors and those factors discussed from time to time in Thoratec's public reports filed with the Securities and Exchange Commission, such as those discussed under the heading, "Risk Factors," in Thoratec's most recent annual report on Form 10-K and as may be updated in subsequent SEC filings. These forward-looking statements speak only as of the date hereof. Thoratec undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.