Boston Scientific Corp. (NYSE:BSX) announced a voluntary Class 1 recall of all unused units of its iCross coronary imaging catheters due to a problem with tip detachments.
The recall does not affect patients already treated with the iCross catheter, as the problem occurs during implantation.
Between April 1 and May 10 this year Boston Scientific confirmed eight occurrences of catheter tip detachments due to embrittlement. There are nearly 30 thousand units distributed in the U.S. and its territories.
The Natick, Mass. medical device giant has promised to replace all returned iCross units with the Atlantis SR Pro model free of charge, according to the release.
EMIT Corp. wins 510(k) clearance for blood and fluid warmer
EMIT Corp. announced FDA 510(k) clearance for its HypothermX device, a portable device which warms intravenous fluids, blood or blood products using a flameless combustion process. The device weighs less than three pounds and has a battery life of more than four hours with continuous use, the Houston, Texas-based company said.