Class I Medical Device Recall Alert: ACIST Kodama Intravascular Ultrasound Catheter
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ACIST Medical Systems has recalled 490 units of Kodama Intravascular Ultrasound Catheters due to high risks associated with the O-ring housing tubing. Post-distribution it was found that the tubing could potentially damage the O-ring while in use, causing pieces of the device to break and flush into the patient’s artery.
Following the mailing of an Urgent Medical Device Recall letter by ACIST, the U.S. Food & Drug Administration (FDA) announced a Class I recall, the most urgent and serious type of recall. The recall was initiated after additional adverse health complications were discovered, including blood vessel blockage, heart attack, heart arrhythmia, stroke, and death.
What Is an Intravascular Ultrasound Catheter?
The ACIST Kodama Intravascular Ultrasound Catheter is a thin, flexible tube with a small ultrasonic transducer attached to one end. The device uses high-frequency ultrasound waves to view the inside of an artery, providing a real time view of the degree of narrowing or thickening of the artery and gauge of plaque buildup. The catheter is used in conjunction with the ACIST HDi System and is inserted through an artery in the leg then guided to the targeted area.
Physicians typically use Intravascular Ultrasound (IVUS) to image an artery in preparation for, during or to review coronary and peripheral intravascular pathology. The device is intended to be used on patients who are candidates for transluminal interventional procedures.
Why Was the ACIST Kodama Intravascular Ultrasound Catheter Recalled?
ACIST Medical Systems recalled their Kodama Intravascular Ultrasound Catheter after test results from the manufacturing line found a piece of damaged O-ring in an unintended section of the catheter. Then learning the possibility that the O-ring housing tubing may squeeze and damage the O-ring which can cause fine pieces of the device to break free and potentially flush out of the catheter into a patient’s artery. This could cause detrimental harm to patients including:
- Blood vessel blockage
- Heart attack
- Heart arrhythmia
- Chest pain or discomfort
Patients that struggle with heart ventricle-related issues are at a higher risk of experiencing severe injuries due to the risk of a sudden blockage of blood flow. Most concerningly, if the catheter is imaging an artery that supplies blood to another partly blocked or narrowed blood vessel, there is an increased risk of more than one arteries being blocked which could result in life-threatening complications.
What Devices Were Recalled?
On January 18, 2021, ACIST initiated a recall of almost 500 catheters globally distributed between November 2020 and January 2021 with the following lot numbers:
What to Do if You Believe You Have Been Harmed by a ACIST Kodama Intravascular Ultrasound Catheter?
If you or someone you love has reason to believe they were injured by an ACIST Kodama Intravascular Ultrasound Catheter, contact our nationwide product liability litigation team to explore your legal options. For more than two decades, our experienced trial attorneys have compassionately advocated for tens of thousands of victims injured by defective medical devices. Meyers & Flowers has proved a track record of taking on big pharmaceuticals and major corporations - having won more than $6 billion for our clients. We are confident that we can do so again representing plaintiffs in Kodama Catheter lawsuits against ACIST Medical Systems. Contact us at [email protected], by filling out a free case evaluation form , or at 877-221-2511.