The FDA yesterday designated an Acist Medical Systems recall of Kodama intravascular ultrasound catheters as Class I, its most serious level. The Kodama intravascular ultrasound catheter (HD-IVUS) is designed to view the inside structure of an artery and any devices therein using high-frequency sound waves. The device is inserted through an … [Read more...] about FDA issues Class I recall of Acist Kodama intravascular ultrasound catheter