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Boston Scientific Announces Voluntary Recall of iCross™ Coronary Imaging Catheters
Date:5/27/2011

to health associated with retrieval attempts (percutaneous or surgical).  To date, the majority of confirmed brittle tip detachments have been successfully retrieved (typically snared percutaneously).  Because the potential for tip detachment is undetectable prior to use, modifications to the IVUS procedure will have little impact on the likelihood of occurrence of these events.

Products affected by this recall were distributed only to hospitals in the U.S. and its territories.  Boston Scientific will replace, free of charge, all returned iCross Coronary Imaging Catheters with Atlantis SR Pro Coronary Imaging Catheters, which will operate with Boston Scientific's IVUS imaging consoles and are immediately available.  The Company does not expect this recall to have a material financial impact.

Boston Scientific 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.

The FDA has determined this action is a Class I recall.  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.  

About Boston Scientific

Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties.  For more information, please visit: www.bostonscientific.com.  

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statement
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SOURCE Boston Scientific Corporation
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