The recall is due to a risk of broken O-ring pieces flushing into arteries while the device is being used, according to the FDA, which identifies it as a class I recall, the most serious level. The recall was initiated on January 18. The recall applies to catheters distributed between November 10, 2020, and January 14 of this year.
The Kodama device uses high-frequency ultrasound to visualize the inside of an artery, the FDA said. As of yet, there have been no reported complaints, injuries, or deaths due to its malfunction, the FDA said.
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