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What’s the Problem?
According to the U.S. Food & Drug Administration (FDA) [1], this Class 1 Recall affects ACIST Kodama Intravascular Ultrasound Catheters, lot numbers 00233370, 00233371, 00233372, 00233373 and 00233385.
If pieces of a catheter break free and flush into the patient’s artery during use, it could cause the following complications:
- Vessel blockage
- Heart attack
- Heart arrhythmia
- Stroke
- Chest pain/discomfort
- And more
The ACIST Kodama Intravascular Ultrasound Catheter (HD-IVUS) uses high-frequency ultrasound waves to view the inside of an artery. The device is inserted through an artery in the leg and guided to the targeted area.
The recalled catheters were distributed in the U.S. from Nov. 10, 2020, to Jan. 14, 2021.
Any reports of illness, injury, or other health consequences related to the use of the recalled Kodama catheter should be reported to ACIST Customer Support. This recall began on January 18, 2021.
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FAQs:
What Is the Acist Kodama Catheter?
The Acist Kodama Catheter is a medical device used for diagnostic and therapeutic procedures in the cardiovascular system. It is designed to help doctors visualize and treat conditions within the blood vessels.
Why Are There Lawsuits Against the Acist Kodama Catheter?
There are lawsuits against the Acist Kodama Catheter due to allegations that the device is defective and has caused serious injuries to patients, including vascular damage and other complications.
What Injuries Have Been Linked to the Acist Kodama Catheter?
Injuries that have been linked to the Acist Kodama Catheter include vascular damage, internal bleeding, and other severe complications that may require additional medical treatment or surgery.
Who Can File a Lawsuit Related to the Acist Kodama Catheter?
Patients who have suffered injuries or complications due to the Acist Kodama Catheter can file a lawsuit related to the Acist Kodama Cathether. It is important to consult with a legal professional to determine eligibility and understand the legal process.
What Kind of Compensation Might Be Available in an Acist Kodama Catheter Lawsuit?
Compensation that might be available in an Acist Kodama Catheter lawsuit may cover medical expenses, lost wages, pain and suffering, and other damages related to the injuries caused by the device.
Do I Have an ACIST Kodama Catheter Lawsuit?
The Medical Device Litigation Group at Schmidt & Clark, LLP law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in ACIST 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.
References:
- https://www.fda.gov/medical-devices/medical-device-recalls/acist-recalls-kodama-intravascular-ultrasound-catheter-due-risk-broken-o-ring-pieces-flushing
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