Boston Scientific recalls catheters
NEW YORK |
NEW YORK (Reuters) - Medical device maker Boston Scientific Corp said it has recalled more than 29,000 of its iCross coronary imaging catheters after receiving reports of the catheter tip detaching during procedures.
The recall involves 29,664 iCross catheters distributed in the United States, Puerto Rico, Trinidad, Tobago and the American Virgin Islands, the company said on Friday.
The voluntary recall was undertaken after the company received confirmed reports of eight occurrences of catheter tip detachments between April 1, 2010 and May 10, 2011.
The breakdown of the catheters while inside a blood vessel can cause blood clots, heart attacks, strokes and death.
The catheters, which were found to have become brittle, allowing for the tip to break off, are used to enable doctors to get ultrasound images of blood vessels in patients who are candidates for interventional procedures, such as artery-clearing angioplasty.
Boston Scientific said it does not expect the recall to have a material financial impact.
The company said it has identified a solution to the problem and submitted the information to the U.S. Food and Drug Administration.
(Reporting by Bill Berkrot; Editing by Richard Chang)
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