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
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