What's the Problem?
According to the U.S. Food & Drug Administration (FDA), 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
- 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 consequence related to the use of the recalled Kodama catheter should be reported to ACIST Customer Support
This recall began on January 18, 2021.
Do I Have an ACIST Kodama Catheter Lawsuit?
The Medical Device Litigation Group at our 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.