April 4, 2012 / 7:06 PM / 6 years ago

UPDATE 2-FDA issues recall on Thoratec HeartMate II pump

* Thoratec changes label to prevent serious side effects

* Announcement made public by FDA on Wednesday

* Thoratec shares fall 4.4 percent

By Toni Clarke

April 4 (Reuters) - The U.S. Food and Drug Administration announced a recall on Wednesday of Thoratec Corp’s HeartMate II pump, sending the company’s shares down 4.4 percent.

The company is not required to withdraw any product from the market or cease selling it, but surgeons have been issued with new instructions about how to implant the device, which is designed to increase blood flow in patients with heart failure.

The recall is to “fix” the instructions rather than the product, to make sure that surgeons do not insert it improperly.

Thoratec announced on March 19 that it had initiated a worldwide “medical device correction notification” in which it reported it had received 29 reports of a fault in one component of the device, and it issued new instructions for implanting it.

Thoratec said in a statement on Wednesday that after its voluntary notification, the FDA posted information about the action on its website.

“Today, this same information appeared in the news section of the FDA website,” the company said. “However, today’s posting was only a reference to the previous communication, and there was no new information provided.”

FDA spokeswoman Sarah Clark-Lynn confirmed Thoratec’s statement. The agency designated it as a Class 1 recall, the most serious type, and said that if the new instructions are not followed the device could cause serious complications and even death.

The HeartMate II is implanted in the abdomen. One connector, known as the inflow conduit, brings blood from the heart into the pump. An outflow tube, or graft, carries blood from the pump to the aorta. The component at issue is known as the bend relief, which slides over the outflow graft to prevent it from kinking and impeding blood flow.

In a prior version of the pump, the bend relief and outflow graft were attached to the pump, but in early 2011, Thoratec introduced a new version, in which the bend relief was made detachable. The new version was designed to make it easier for surgeons to take air out of the graft.

However, the company received complaints that the bend relief could become detached from the pump. In five cases additional surgery was needed. There was one death, though Taylor Harris, senior director of investor relations, said it was unclear whether the death was related to the bend relief or another issue.

Clinicians have now been instructed to follow revised instructions for use which, according to the FDA, “clarify the recommended procedure for securing the bend relief to the outflow graft.”

Thoratec said it does not anticipate any material financial impact from Wednesday’s posting.

David Roman, an analyst at Goldman Sachs, said in a research note that while the announcement ”may cause some concern in the clinical community near term, we see the issues at hand as addressable.

“Given that the heart failure patient population has no alternative therapy and that Thoratec has no immediate competition in the U.S., we do not anticipate a material change to current 2012 Street forecasts.”

Shares of Heartware International Inc, which is developing a rival product, fell 2 percent to $64.58. Thoratec’s shares fell 4.4 percent to $32.83 on the Nasdaq.

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