What’s the Problem?
This FDA Class 1 Recall began on Jan. 18, 2021, and affects ACIST Kodama Intravascular Ultrasound Catheters, lot numbers 00233370, 00233371, 00233372, 00233373 and 00233385. The recalled catheters were distributed in the U.S. from Nov. 10, 2020, to Jan. 14, 2021.
ACIST Medical Systems initiated this recall after determining that the O-ring housing tubing on affected catheters may squeeze and damage the O-ring, causing pieces of the device to 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,” FDA said. “Patients with heart ventricles that do not function properly are at higher risk of experiencing serious harm due to sudden blockage of blood flow.”
The Kodama Intravascular Ultrasound Catheter uses high-frequency ultrasound waves to view the inside of an artery. The catheter is inserted through an artery in the leg and guided to the targeted area.
If you were implanted with a Kodama catheter and are now experiencing any negative health effects, you should contact your healthcare provider immediately.
Do I Have a Kodama Catheter Class Action Lawsuit?
The Class Action Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Kodama Catheter Lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
If you or a loved one was injured by a recalled catheter, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.