Massachussetts-based Boston Scientific on Friday announced the recall of more than 29,000 of its iCross Coronary Imaging Catheters distributed in the U.S. mainland, Puerto Rico, Trinidad & Tobago and the U.S. Virgin Islands.
The medical device manufacturer said in a statement it opted to take the corrective action “due to confirmed occurrences of catheter tip detachments due to embrittlement of the catheter material.”
Boston Scientific admitted that between April 1, 2010 and May 10, 2011, it has confirmed eight occurrences in the U.S. and Puerto Rico of catheter tips detaching as they became brittle, which it said “translates to a rate of 0.027 percent, based on available market data.”
The breakdown of the catheters while inside a blood vessel can cause blood clots, heart attacks, strokes and death, the company explained.
The device is used in intravascular ultrasound imaging in patients who are candidates for transluminal coronary interventional procedures. The catheters are intended to operate with Boston Scientific’s ClearView Ultra, Galaxy, Galaxy 2 or iLab IVUS imaging consoles, the company said.
To date, the majority of confirmed brittle tip detachments have been successfully retrieved, the company said, noting it does not expect the recall to represent a material financial impact to its operations.
“Today’s action does not affect patients who have already received treatment with the recalled devices because the potential problem occurs during the procedure,” Boston Scientific said in a statement. “The company has identified a solution and has submitted this information to the U.S. Food and Drug Administration for approval.”
The company said its Atlantis SR Pro device is available immediately as a substitute for the faulty catheter.