Thoratec Comments on February 23rd Voluntary Medical Device Correction Notification

Thoratec Corporation THOR today commented on a recent voluntary medical device correction 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.