Boston Scientific has commenced a voluntary recall of nearly 30,000 imaging catheters that were distributed in the U.S. and U.S. territories, after multiple confirmed cases of catheter tip detachments in the iCross coronary imaging catheters. The devices, used in intravascular ultrasound (IVUS) in patients who are candidates for transluminal coronary interventional procedures, are part of an FDA Class I recall.
The corrective action, announced May 27, is being taken due to eight confirmed cases of catheter tip detachments caused by the embrittlement of catheter material. The Natick, Mass.-based company confirmed a rate of 0.027 percent of catheter tip detachments in the U.S. and Puerto Rico from April 1, 2010, to May 10, 2011.
The catheters are intended to operate with Boston Scientific’s ClearView Ultra, Galaxy, Galaxy2 or iLab IVUS imaging consoles.
Potential health risks associated with this type of failure include vessel wall injury, thrombotic events, retained foreign body, foreign body embolization, myocardial infarction and death, according to the company. There are additional risks to health associated with retrieval attempts. The majority of confirmed brittle tip detachments have been successfully retrieved, according to the press release.
Boston Scientific said it is notifying affected hospitals through detailed recall notification letters, including instructions on how to return the recalled product, which also are located on the company’s website.