Boston Scientific Corporation (NYSE: BSX) today announced that it is voluntarily recalling all of its iCross™ Coronary Imaging Catheters 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, Trinidad, Tobago and the American Virgin Islands. The Company's Atlantis® SR Pro, Atlantis ICE, Atlantis Ultra ICE, Atlantis .018, Atlantis PV and Sonicath® Ultra 9 Catheters used with the iLab, ClearView and Galaxy IVUS imaging consoles are not impacted by this recall, with the Atlantis SR Pro available immediately as a substitute.
This corrective action is being taken due to confirmed occurrences of catheter tip detachments due to embrittlement of the catheter material. Between April 1, 2010 and May 10, 2011, Boston Scientific has confirmed eight occurrences of catheter tip detachments due to embrittlement in the U.S. and Puerto Rico. Based on available market data, this translates to a rate of 0.027 percent. Today's action does not affect patients who have already received treatment with the recalled devices because the potential problem occurs during the procedure. The Company has identified a solution and has submitted this information to the U.S. Food and Drug Administration (FDA) for approval.
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 retrieval attempts (percutaneous or surgical). To date, the majority of confirmed brittle tip detachments have been successfully retrieved (typically snared percutaneously). Because the potential for tip detachment is undetectable prior to use, modifications to the IVUS procedure will have little impact on the likelihood of occurrence of these events.
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