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Boston Scientific Recalls
iCross™ Intravascular Ultrasound (IVUS) Coronary Imaging Catheters
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iCross™ Coronary
Imaging Catheter |
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May 28, 2011 --
Boston Scientific Corporation (NYSE: BSX) announced on Friday
that it is voluntarily recalling all of its iCross™ Coronary
Imaging Catheters due to reports of catheter
tip detachments caused by embrittlement of the catheter
material. These intravascular ultrasound
(IVUS) imaging devices are used in angioplasty and stent procedures
to help place and size stents more accurately. The company
reports that the recall affects almost 30,000
units distributed in the United States, Puerto Rico, Trinidad,
Tobago
and the American
Virgin
Islands. These catheters are
intended to operate with Boston Scientific's ClearView Ultra™,
Galaxy™, Galaxy®2 or iLab® IVUS imaging consoles. |
The Company's
Atlantis® SR Pro, Atlantis ICE, Atlantis Ultra ICE, Atlantis .018,
Atlantis PV and Sonicath® Ultra 9 Catheters used with the iLab,
ClearView and Galaxy IVUS imaging consoles are not impacted by
this recall and, in fact, Boston Scientific said in a press release
that it will make the Atlantis SR Pro available immediately as
a substitute, free
of
charge.
Over the past year, Boston Scientific
has been able to confirm eight occurrences of catheter
tip detachments due to embrittlement, which translates to a failure
rate of 0.027%, less than 3 instances out of 10,000. However, because
of the potential for serious injury from a detached tip, the FDA
has determined that this action is a Class I recall, the most
serious
category,
defined
as
"a situation
in which
there is a reasonable probability that the use of or exposure to
a violative product will cause serious adverse
health consequences or death."
Importantly, the problem is one that occurs only during the procedure
itself, so this action does not affect patients who have already
received treatment with the recalled devices. The company also reports
that
the majority of confirmed brittle tip detachments have been successfully
retrieved
(typically snared percutaneously).
Boston Scieitific does
not expect this recall to have a material financial impact.
The company is notifying affected hospitals through
detailed recall notification letters, including instructions on how
to
return recalled product. The notification and instructions may also
be found
on
the Boston Scientific website. For additional information
regarding this
recall, please contact Boston Scientific at 1-800-811-3211.
Any adverse
reactions
experienced with the use of this product and/or quality
problems
should also be reported to the FDA's MedWatch Program by
phone at 1-800-FDA-1088,
or on the MedWatch website at www.fda.gov/medwatch.
Reported by Burt Cohen, May 28, 2011
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