Kodama Catheter Recall Issued Due To Risk Broken Pieces May Flush Into Patient Arteries

Federal health officials have announced a Class I recall for certain ultrasound catheters, after discovering pieces of the tubing may break free while in use, causing material to enter into a patient’s artery.

The FDA announced the Kodama catheter recall on March 17, indicating the O-ring housing tubing may become damaged and break during use, increasing the risk of rubber material causing a vessel blockage, which could cause serious adverse health consequences, including death.

The recall impacts certain ACIST Kodama Intravascular Ultrasound Catheters, which use high-frequency sound waves to view the inside of an artery. The devices are inserted through an artery in the leg, and guided to an area of the body for health care providers to view.

According to the recall notice, the O-ring housing tubing may squeeze and damage the O-ring, allowing it to break and flush through a patients arteries. FDA officials are warning that in this event patients could suffer a blood vessel blockage, heart attack, heart arrhythmia, or stroke.

Patients with certain pre-existing conditions, such as improperly functioning heart ventricles, are at an increased risk of series injury or death in the event of a sudden blockage of blood flow.

On January 22, manufacturing firm ACIST Medical Systems, released an Urgent Medical Device Recall letter instructing healthcare facilities to remove all potentially defective Kodama HD-IVUS Catheters from their inventory.

Specifically, the recall impacts Kodama Intravascular Ultrasound Catheters manufactured by ACIST Medical Systems and distributed to medical facilities across the nation between November 10, 2020 and January 14, 2021. The recalled products contain lot numbers 00233370, 00233371, 00233372, 00233373, or 00233385.

The recall instructs all healthcare facilities to record the quantities of the products in their inventory and to return the recall notice letter along with the completed Recall Response Form for information on how to arrange product returns.

While no injuries or adverse reports have been reported to date, the FDA has classified this action as a Class I recall, indicating it is the most serious of its kind, and that use of the recalled catheters may result in serious adverse health consequences or death.