FDA MedWatch - Kodama Intravascular Ultrasound Catheter by ACIST:

Class I Recall - Due Due to Risk of Broken O-Ring Pieces Flushing into Arteries During Use

MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: Kodama Intravascular Ultrasound Catheter by ACIST: Class I Recall - Due to Risk of Broken O-Ring Pieces Flushing into Arteries During Use AUDIENCE: Patient, Health Professional, Risk Manager, Cardiology ISSUE: ACIST Medical Systems is recalling their ACIST Kodama Intravascular Ultrasound Catheter 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, with associated chest pain or discomfort. 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 one artery. There have been no complaints, injuries, or deaths reported. For more information about this recall, click on the red button "Read Recall" below. BACKGROUND: The ACIST Kodama Intravascular Ultrasound Catheter (HD-IVUS) uses high-frequency sound waves (ultrasound), to view the inside of an artery, including the structure of the artery, and any devices such as stents. It is inserted through an artery in the leg and guided to the area that health care providers need to see. This catheter is intended to be used with the ACIST HDi System. RECOMMENDATIONS: On January 22, 2021, ACIST sent an Urgent Medical Device Recall letter to all affected customers. The letter gave the following instructions: Check inventory of Kodama HD-IVUS Catheter for the following Lot Numbers: 00233370, 00233371, 00233372, 00233373, 00233385. Record quantities of each lot in the Response Form included with the recall notice letter. Remove the affected lots from inventory. Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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