May 31, 2011 – Boston Scientific Corp. announced it is voluntarily recalling all of its iCross intravascular ultrasound (IVUS) coronary imaging catheters. The company said there have been several occurrences of the catheter tip detaching 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 United States and Puerto Rico. Based on available market data, this translates to a rate of 0.027 percent.
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.
These catheters are intended to operate with Boston Scientific's ClearView Ultra, Galaxy, Galaxy2 or iLab IVUS imaging consoles. This recall affects all iCross 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.
The recall 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.
Products affected by this recall were distributed only to hospitals in the U.S. and its territories. Boston Scientific will replace, free of charge, all returned iCross catheters with Atlantis SR Pro coronary imaging catheters, which will operate with Boston Scientific's IVUS imaging consoles and are immediately available.
The company does not expect this recall to have a material financial impact.
Boston Scientific is notifying affected hospitals through detailed recall notification letters, including instructions on how to return recalled product. The notification and instructions may also be found on the Boston Scientific website. For additional information regarding this recall, please contact Boston Scientific at (800) 811-3211.
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 website at www.fda.gov/medwatch.
For more information: www.bostonscientific.com