Boston Scientific Recalls iCross Coronary Imaging Catheters in United States

May 27, 2011—Boston Scientific Corporation (Natick, MA) announced that it is voluntarily recalling the company's entire line of iCross coronary imaging catheters, which are used in intravascular ultrasound (IVUS) imaging in patients who are candidates for transluminal coronary interventional procedures. These catheters are intended to operate with Boston Scientific's ClearView Ultra, Galaxy, Galaxy 2, or iLab IVUS imaging consoles. This recall affects all iCross coronary imaging catheters, approximately 29,664 units distributed in the United States, Puerto Rico, the US Virgin Islands, and the Republic of Trinidad and Tobago.

The recall does not affect the company's Atlantis SR Pro, which is available immediately as a substitute. Also not affected by the recall are the Atlantis ICE (intracardiac echo), Atlantis Ultra ICE, Atlantis 0.018-inch peripheral, Atlantis PV peripheral, and Sonicath Ultra 9 peripheral catheters used with the iLab, ClearView, and Galaxy IVUS imaging consoles.

According to Boston Scientific, this corrective action is being taken because of eight confirmed occurrences of catheter tip detachments that were due to embrittlement of the catheter material. The incidents were reported between April 1, 2010 and May 10, 2011 in the United States and Puerto Rico. Based on available market data, this translates to a rate of 0.027%.

This action does not affect patients who have already received treatment with the recalled devices because the potential problem occurs during the procedure. The company stated that it has identified a solution and submitted this information to the US Food and Drug Administration (FDA) for approval.

The FDA has determined this action is a Class I recall. Any adverse reactions experienced with the use of this product and/or quality problems should also be reported to the FDA's MedWatch program by phone at (800) FDA-1088 or on the MedWatch Web site.

Boston Scientific stated that 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. There are additional risks to health associated with percutaneous and surgical retrieval attempts. To date, the majority of confirmed brittle tip detachments have been successfully retrieved (typically snared percutaneously). The potential for tip detachment is undetectable before use; modifications to the IVUS procedure will have little impact on the likelihood of occurrence of these events.

The company advised that products affected by this recall were distributed only to hospitals in the United States and its territories. 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.

Boston Scientific is notifying affected hospitals through detailed recall notification letters, including instructions on how to return the recalled product. The notification and instructions may also be found on the Boston Scientific Web site. For additional information regarding this recall, Boston Scientific can be contacted at (800) 811-3211.