Wednesday, March 17, 2021

ACIST Recalls Kodama HD-IVUS

Learn more about ACIST Recall of the Kodama HD-IVUS

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US Food and Drug Administration

ACIST Recalls Kodama Intravascular Ultrasound Catheter Due to Risk of Broken O-Ring Pieces Flushing into Arteries During Use

ACIST is recalling the Kodama Intravascular Ultrasound Catheter because the O-ring housing tubing may squeeze and damage the O-ring. If this happens, pieces of the O-ring may break free and flush into the patient's artery during use and this may lead to serious adverse events.

The FDA has identified this as a Class I recall, the most serious type of recall.

Read the Recall Notice


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