Boston Scientific Recalls Catheters
Natick-based medical device manufacturer Boston Scientific is recalling more than 29,000 imaging catheters because of a defect, the company announced late Friday.
The iCross Coronary imaging catheter is used by doctors to create images of blood vessels.
The company said there have been eight reported instances since April 2010 of the catheter's tip detaching during procedures. There are 29,664 units distributed across the United States, Puerto Rico and select other markets.
The company voluntarily issued the recall notice and a solution to the problem is pending U.S. Food & Drug Administration approval.
The company does not expect the recall to have a "material" financial impact on earnings.
Boston Scientific is replacing all iCross Coronary imaging catheters free of charge with another type of Boston Scientific imaging catheter. Doctors with questions can call the company at 1-800-811-3211.
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