Boston Scientific Corp is recalling its iCross coronary imaging catheters due to reports that the catheter tip detaches during procedures.
The recall involves more than 29,000 iCross catheters distributed in the U.S., Puerto Rico, Tobago, Trinidad and the Virgin Island, according to the company.
The recall was prompted after eight reported incidents of the catheter tip detaching between April 1, 2010 and May 10, 2011. The company said the detachment could possibly cause a heart attack or even death
The company said it has identified a solution to the problem and submitted the information to the U.S. Food and Drug Administration (FDA) for approval.
The medical devices are used in imaging procedures for heart patients.
For more information regarding this recall, please call Boston Scientific at 1-800-811-3211. Any adverse reactions should be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, or on the MedWatch Web site.
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