FDA: Class I recall of ACIST Kodama Intravascular Ultrasound Catheter

Editor's Note

The Food and Drug Administration (FDA), on March 17, identified the recall by ACIST of its Kodama Intravascular Ultrasound Catheter as Class I, the most serious.

The recall was initiated because the O-ring housing tubing may squeeze and damage the O-ring. If there is damage, broken O-ring pieces could be flushed into the patient's artery during use. This could result in vessel blockage, heart attack, heart arrhythmia, or stroke.

Distribution dates were November 10, 2020 to January 14, 2021. To date, no complaints, injuries, or deaths have been reported.