Thoratec Clarifies Recall News (THOR)

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By Jon C. Ogg Updated Published
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There is good news and bad news on Thoratec Corporation (NASDAQ: THOR) today.  The bad news is that it did have a FDA news recall of its HeartMate II® Left Ventricular Assist System.  The good news is that the dates on the FDA recall page were not fresh. We pointed this out in our first news about the recall.  You know how traders and investors can be… Shoot first and ask questions later.

Thoratec issued a statement commenting about the recall 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.  Here is what matters today: “The company initiated the voluntary Notification to clinicians on February 23, 2012.”

The company noted, “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.

Thoratec has also contacted all hospitals where the HeartMate II sealed outflow grafts had been distributed.  It noted, “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.”

This was a situation where the news seemed more like re-news.  It has happened before and it will happen again in the future.  After having been down as much as 10% earlier, Thoratec shares are down just under 4.5% at $32.81.  It is probably safe to assume that analysts who rate Thoratec as “Buy” and “Outperform” will be defending this one Thursday morning.

JON C. OGG

Contact [email protected] for any questions or corrections.

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About the Author Jon C. Ogg →

Jon Ogg has been a financial news analyst since 1997. Mr. Ogg set up one of the first audio squawk box services for traders called TTN, which he sold in 2003. He has previously worked as a licensed broker to some of the top U.S. and E.U. financial institutions, managed capital, and has raised private capital at the seed and venture stage. He has lived in Copenhagen, Denmark, as well as New York and Chicago, and he now lives in Houston, Texas. Jon received a Bachelor of Business Administration in finance at University of Houston in 1992. www.247wallst.com.

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