Medical-device maker Boston Scientific Corp. (BSX) said it is recalling ICross coronary imaging catheters after getting reports that the tip of the device detached inside patients.
The devices are used in imaging procedures for heart patients. The company is recalling 29,664 of the catheters distributed to hospitals in the U.S., Puerto Rico, Trinidad, Tobago and the American Virgin Islands, Natick, Massachusetts- based Boston Scientific said today in a statement.
The catheter tips may come off when the device becomes too brittle, the company said in its statement. Eight confirmed cases have been reported since April 1, 2010, of the device breaking, which can hurt blood vessel walls, create clotting, or leave the part trapped in the patient and force another procedure to retrieve it.
No patients died as a result of the malfunctions, Eric Olson, a spokesman for Boston Scientific, said in a telephone interview. Boston Scientific said it will replace the recalled devices with other brands of imaging catheters.
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