Medical device maker Boston Scientific Corp. said Friday it is recalling more than 29,000 catheters used in imaging procedures after several devices broke while in use.
The recall affects all iCross Coronary Imaging Catheters distributed to hospitals in the U.S. Puerto Rico, Trinidad, Tobago and the American Virgin Islands. The devices use ultrasound imaging technology to reveal potentially dangerous plaque that builds up in arteries.
Boston Scientific says it has confirmed eight incidents when the tip of a catheter broke off during a procedure. The problem can cause artery injury, blood clots, heart attack and other problems.
The company says it has identified a solution to the problem and has submitted it to the Food and Drug Administration.