Johnson & Johnson ($JNJ) subsidiary Cordis is in the hot seat over its Fire Star Rx PTCA dilation catheters. The company has launched a recall of a single lot of the devices because of concerns over flawed deflation.
Company spokeswoman Sandy Pound told MassDevice that 292 units are affected by the recall. All were distributed in China, India, Indonesia, South Korea and Taiwan, according to the story.
So far, at least 8 adverse events involving the catheter have been reported to the FDA over March and April, though Pound is quoted as saying that no patients have died or been injured. Cordis dealt with a similar recall in 2008, according to the story. That was a Class I recall, which the FDA considers the most serious.
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