Medical-device manufacturer, Boston Scientific Corp., announced recently that it is recalling ICross catheters used for heart imaging, following reports that the tip of the device detached inside patients. Approximately 30,000 catheters used for coronary imaging procedures were distributed to hospitals in the U.S., Puerto Rico, Trinidad, Tobago and the American Virgin Islands and are subject to the recall.
As of April 1, 2010, there have been eight confirmed reports of catheter tips coming off inside patients when the device becomes too brittle. This malfunction can harm blood vessel walls, create clotting or even result in the broken part remaining trapped in the patient, forcing the need for a retrieval procedure.
While no patients have died as a result of these malfunctions, Boston Scientific said it will replace the recalled devices with other imaging catheters.
