Published by Our lawyers can help. Please click the button below for a Free Confidential Case Evaluation or call our law firm at any time by dialing (866) 588-0600.
Table Of Contents
- ACIST Kodama Catheter Lawsuit Overview
- Latest ACIST Kodama Catheter Lawsuit Updates
- FDA Reports and Statistics
- ACIST Kodama Catheter Injuries & Side Effects
- Do You Qualify for an ACIST Kodama Catheter Lawsuit?
- ACIST Kodama Catheter Recall Information
- Statute of Limitations for ACIST Kodama Catheter Lawsuits
- FAQs
- 1. What Is the ACIST Kodama Catheter?
- 2. Why Are There Lawsuits Against the ACIST Kodama Catheter?
- 3. What Injuries Have Been Linked to the ACIST Kodama Catheter?
- 4. Who Can File a Lawsuit Related to the ACIST Kodama Catheter?
- 5. What Kind of Compensation Might Be Available in an ACIST Kodama Catheter Lawsuit?
- Get a Free ACIST Kodama Catheter Lawsuit Evaluation With Our Lawyers
ACIST Kodama Catheter Lawsuit Overview
The ACIST Kodama Catheter lawsuit involves claims against ACIST Medical Systems regarding their Kodama Intravascular Ultrasound Catheter (HD-IVUS) due to defective O-rings that can break and flush into patients’ arteries during use. The primary allegations center on the device’s potential to cause serious cardiovascular complications when catheter pieces break free and block blood vessels.
Latest ACIST Kodama Catheter Lawsuit Updates
- January 18, 2021 – The FDA issued a Class 1 recall for ACIST Kodama Intravascular Ultrasound Catheters due to the risk of broken O-ring pieces flushing into patients’ arteries during use [1].
FDA Reports and Statistics
The FDA classified this as a Class 1 recall, which represents the most serious type of recall for medical devices that could cause serious injury or death. The recall affects ACIST Kodama Intravascular Ultrasound Catheters from five specific lot numbers that were distributed across the United States over a three-month period.
The FDA requires that any reports of illness, injury, or other health consequences related to the use of the recalled Kodama catheter be reported to ACIST Customer Support immediately.
ACIST Kodama Catheter Injuries & Side Effects
The ACIST Kodama Catheter has been linked to serious cardiovascular complications when catheter pieces break free and flush into patients’ arteries during medical procedures.
Serious side effects include:
- Vessel blockage: Obstruction of blood flow in arteries
- Heart attack: Myocardial infarction due to blocked coronary arteries
- Heart arrhythmia: Irregular heartbeat patterns
- Stroke: Brain injury from blocked cerebral blood vessels
- Chest pain/discomfort: Cardiovascular-related pain symptoms
Do You Qualify for an ACIST Kodama Catheter Lawsuit?
You may qualify for an ACIST Kodama Catheter lawsuit if:
- You received treatment with an ACIST Kodama Intravascular Ultrasound Catheter between November 2020 and January 2021
- You experienced serious side effects including vessel blockage, heart attack, heart arrhythmia, stroke, or chest pain
- The injuries required medical treatment or hospitalization
- You can provide medical documentation linking your injuries to the ACIST Kodama Catheter
Evidence Required for an ACIST Kodama Catheter Lawsuit
To pursue a successful ACIST Kodama Catheter lawsuit, you will need:
- Complete medical records documenting your cardiovascular procedure
- Evidence of the specific catheter model and lot number used during your treatment
- Documentation of complications and injuries that occurred during or after the procedure
- Medical bills and treatment records related to your injuries
Damages You Can Recover
Compensation in an ACIST Kodama Catheter lawsuit may include:
- Medical expenses for treatment of complications
- Lost wages due to inability to work
- Pain and suffering from physical and emotional distress
- Punitive damages in cases of manufacturer negligence
ACIST Kodama Catheter Recall Information
The FDA issued a Class 1 recall on January 18, 2021, for ACIST Kodama Intravascular Ultrasound Catheters. The recall affects lot numbers 00233370, 00233371, 00233372, 00233373, and 00233385.
These devices were distributed in the United States from November 10, 2020, to January 14, 2021. The recall was initiated due to the risk of broken O-ring pieces flushing into patients’ arteries during use.
Statute of Limitations for ACIST Kodama Catheter Lawsuits
Time limits for filing ACIST Kodama Catheter lawsuits vary by state, typically ranging from one to three years from the date of injury discovery. Given that the recall occurred in January 2021, potential claimants should act quickly to preserve their legal rights. It is crucial to consult with an experienced medical device attorney as soon as possible to ensure your claim is filed within the appropriate timeframe.
FAQs
1. 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 uses high-frequency ultrasound waves to view the inside of an artery and is inserted through an artery in the leg and guided to the targeted area.
2. 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. The FDA issued a Class 1 recall due to broken O-ring pieces that can flush into patients’ arteries.
3. What Injuries Have Been Linked to the ACIST Kodama Catheter?
Injuries that have been linked to the ACIST Kodama Catheter include vessel blockage, heart attack, heart arrhythmia, stroke, chest pain, and other severe complications that may require additional medical treatment or surgery.
Patients who have suffered injuries or complications due to the ACIST Kodama Catheter can file a lawsuit related to the device. It is important to consult with a legal professional to determine eligibility and understand the legal process.
5. 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.
Related Articles:
See all related defective medical device lawsuits we’ve taken on.
Get a Free ACIST Kodama Catheter Lawsuit Evaluation With Our Lawyers
Time is limited to pursue legal action against ACIST Medical Systems for injuries caused by their defective Kodama catheter. With statutes of limitations varying by state, typically only 1-3 years from the date of injury discovery, it is crucial to act quickly to preserve your legal rights.
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.
Our services include:
- Free, confidential consultations
- No upfront costs or fees
- Payment only if we win your case
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.
Reference:
https://www.fda.gov/medical-devices/medical-device-recalls/acist-recalls-kodama-intravascular-ultrasound-catheter-due-risk-broken-o-ring-pieces-flushing