FDA Recalls Boston Scientific Coronary Imaging Catheters

June 17, 2011

The U.S. Food and Drug Administration has announced a recall of 110,000 iCross and as Atlantis SR Pro 2 coronary imaging catheters. This follows Boston Scientific’s voluntary recall of iCross catheters announced on May 27.

The U.S. Food and Drug Administration has announced a recall of 110,000 iCross and as Atlantis SR Pro 2 coronary imaging catheters. This follows Boston Scientific’s voluntary recall of iCross catheters announced on May 27.

The voluntary recall did not include the Atlantis SR Pro 2 imaging catheter. The catheters are used with Boston Scientific's ClearView Ultra, Galaxy, Galaxy2 and iLab IVUS imaging consoles, which provide intravascular ultrasound (IVUS) imaging in patients who are candidates for transluminal coronary interventional procedures. 

In the May announcement, the Boston Scientific said that between April 1, 2010 and May 10, 2011, the company had confirmed eight occurrences of catheter tip detachments in the U.S. and Puerto Rico due to brittle catheter material. The problem could cause the tip to break inside the patient and embolize, causing tissue and blood vessel injury, heart attack or other serious events requiring additional unplanned surgery, the FDA says.

Boston Scientific  officials say they’ve identified a solution and submitted it to the FDA for approval, and asks customers to immediately stop using these imaging catheters and return them to the company.