ACIST Kodama Intravascular Ultrasound Catheter Recall Litigation

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Meyers & Flowers is currently litigating cases on behalf of individuals and families who have been harmed by defective medical products – that is, medical drugs or devices that have killed or injured the very people they were supposed to be helping.

The U.S. Food and Drug Administration has announced a Class I recall of 490 units of the ACIST Kodama Intravascular Ultrasound Catheter due to the high risk of an O-ring within the unit breaking while in use, potentially causing small pieces of the O-ring to flush into one or more of the patient’s arteries during use. This could cause serious adverse cardiovascular events or death. “Class I” is the FDA’s strictest class of recall and applies to devices that may cause serious injury or death.

Between November 10, 2020, and January 14, 2021, 490 possible affected catheters were distributed throughout the U.S. On January 18, 2021, manufacturing firm Acist Medical Systems initiated a recall of the product.

What is the ACIST Kodama Intravascular Ultrasound Catheter?

The ACIST Kodama Intravascular Ultrasound Catheter uses ultrasound (high-frequency sound waves) to allow a healthcare provider to look inside an artery. The catheter is used with the ACIST HDi System and is inserted into an artery in the leg and is then guided to the area that needs to be internally inspected. ACIST is the brand name of Acist Medical Systems, manufacturer of the recalled catheter.

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Potential Injuries May Include

ACIST Medical Systems recalled 490 ACIST Kodama Intravascular Ultrasound Catheters over concerns that while the device was in use, an O-ring housing tubing could squeeze and damage the O-ring, causing pieces of the device to break free and flush into the patient’s artery. No complaints, injuries, or deaths have thus far been reported, however, if the anticipated damage were to occur, while the ACIST catheter was in use and fine pieces of the unit’s O-ring were to break free and enter the arteries, the following extreme adverse events could occur:

Blood vessel blockage
Heart attack
Heart arrhythmia
Stroke
Chest pain or discomfort

When and Where the ACIST Kodama Intravascular Ultrasound Catheter May Have Been Used

The ACIST Kodama Intravascular Ultrasound Catheter was distributed globally. The lots that have been identified as defective were distributed in 19 U.S. states and India, Italy, Japan, Poland, and United Arab Emirates.

United States

Alabama
Arkansas
California
Colorado
Florida
Illinois
Kansas
Kentucky
Louisiana

Maryland
Michigan
Missouri
North Carolina
New Jersey
New York
Oklahoma
Pennsylvania
Rhode Island
Tennessee

The ACIST Kodama Intravascular Ultrasound Catheter is intended for the examination of coronary and peripheral intravascular pathology.

What To Do if You Or a Loved One Was Injured

If ACIST Kodama Intravascular Ultrasound Catheters may have injured you or a family member, contact our nationwide Product Liability Litigation Team for legal aid. At Meyers & Flowers, our diligent litigation team is ready to help patients and their loved ones who may have suffered a serious injury, adverse reactions, or even death due to defects of the ACIST Kodama Intravascular Ultrasound Catheter. Our lawyers have a reputation for steadfastly fighting to protect our client's rights in court and securing full and fair rewards, damages, and compensation for them.

If you or a member of your family has experienced an injury and are in need of an ACIST Kodama Intravascular Ultrasound Catheter lawyer in Chicago, Meyers & Flowers stands ready to help. Contact the Meyers & Flowers team to explore your legal options. We can be reached at [email protected], by filling out a free case evaluation form, or at 877-221-2511.