Medical supplies maker Boston Scientific issued a major recall after complaints that some units of its iCross Coronary Imaging Catheters dethatched inside of patients.
The recall involves 29,664 units in the United States, Puerto Rico, Trinidad, Tobago and the American Virgin Islands, the company said on Friday.
The breakdown of the catheters while inside a blood vessel can cause blood clots, heart attacks, strokes and death.
Boston Scientific will replace, free of charge, all returned iCross Coronary Imaging Catheters with Atlantis SR Pro Coronary Imaging Catheters, which will operate with Boston Scientific's IVUS imaging consoles and are immediately available, the company stated.
The catheters are used in IVUS (intravascular ultrasound) imaging in patients who are confirmed as candidates for transluminal coronary intervention.
Boston said it issued the voluntary recall was called after it received complaints between April 1, 2010 and May 10, 2011.
About the specific issue, the company said catheters catheter tip detachments due to embrittlement of the catheter material.
The company said it has identified a solution to the problem and submitted the information to the U.S. Food and Drug Administration.