* 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 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
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
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
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
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
"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.