Boston Scientific announced Friday that it is voluntarily recalling more than 29,000 iCross coronary imaging catheters distributed in the U.S., Puerto Rico, Trinidad, Tobago and the American Virgin Islands. The company is taking this action because of eight occurrences of catheter tip detachments due to embrittlement in the U.S. and Puerto Rico between April 1, 2010 and May 10, 2011.
The catheter is used in patients who receive transluminal coronary interventional procedures. The detachments can cause several adverse events, including vessel wall injury, thrombotic events, myocardial infarction and death. To date, the majority of confirmed brittle tip detachments have been successfully retrieved, the company says in a release.
No patients have died as a result of the malfunctions, Eric Olson, a spokesman for Boston Scientific, said in a telephone interview with Bloomberg.
The action does not affect patients who have already received treatment with the recalled devices because the potential problem occurs during the procedure. Boston Scientific has identified a solution and has submitted this information to the FDA, which has determined this action to be a Class I recall.
- get the Boston Scientific release
- check out the Bloomberg story