The Food and Drug Administration (FDA) has announced a recall of certain lots of the ACIST Kodama Intravascular Ultrasound Catheter due to risk of broken O-ring pieces flushing into arteries during use.
The ACIST Kodama Intravascular Ultrasound Catheter (HD-IVUS) uses ultrasound to view the inside of an artery. It is inserted through an artery in the leg and guided to the area that healthcare providers need to visualize. It is being recalled because the O-ring housing tubing may squeeze and damage the O-ring. If there is damage, pieces of the O-ring may break free and flush into the patient’s artery during use. This could cause serious patient harm, including vessel blockage, heart attack, heart arrhythmia, or stroke. Patients with heart ventricles that do not function properly are at higher risk of experiencing serious harm due to sudden blockage of blood flow. Additionally, if the HD-IVUS catheter is imaging an artery that supplies blood to another partly blocked or narrowed artery, there is a higher risk of blockages in more than 1 artery.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. There have been no complaints, injuries, or deaths reported associated with this issue.
Food and Drug Administration (FDA). ACIST Recalls Kodama Intravascular Ultrasound Catheter Due to Risk of Broken O-Ring Pieces Flushing into Arteries During Use. March 17, 2020. Available at: click here. Accessed March 17, 2020.