Tuesday, June 14, 2011

Boston Scientific recalls 100,000 heart catheters

By Julie M. Donnelly, Boston Business Journal

Boston Scientific Corp. (NYSE: BSX) has recalled more than 100,000 heart catheters because the catheter tip can break inside of the patient causing tissue and blood vessel injury, heart attack or other serious events requiring additional unplanned surgery.

The Natick-based medical device company said in a statement that it confirmed eight cases of “catheter tip detachments due to embrittlement” between April 1, 2010, and May 10, 2011. Boston Scientific alerted customers to the problem on May 27, advising them to discontinue use and send all products back to the company.

The U.S. Food and Drug Administration is calling this a Class 1 recall, the most serious type of recall, because “there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”

The products are coronary imaging catheters used for ultrasound examination of coronary intravascular pathology, in order to determine whether a patient needs interventional coronary procedures.

Subject to this recall are 110,020 devices, under the brand names iCross, which is marketed within the United States and its territories, and Atlantis SR Pro2, which is distributed outside the U.S.