Medical device manufacturer, Boston Scientific recently issued a voluntary recall of more than 29,000 of its iCross coronary imaging catheters, after receiving disturbing reports that the catheter’s tip was detaching during procedures.
The iCross catheters, which were distributed in the U.S., Puerto Rico, Trinidad, Tobago and the American Virgin Islands, were found to have become brittle, allowing for the tip to come loose and break off while doctors use the device to obtain ultrasound images of blood vessels in heart patients.
Boston Scientific released a statement in which the company said it has identified a solution to the problem and has subsequently submitted the information to the U.S. Food and Drug Administration. The company further stated that it does not expect the recall to have a material financial impact.
