ACIST Kodama Catheter Lawsuit | 2026 Latest Updates

ACIST Medical Systems recalled specific lots of its Kodama Intravascular Ultrasound Catheter in January 2021. Manufacturing tests had found damaged O-rings. A loose fragment could pose a serious injury risk during a coronary or peripheral ultrasound procedure. The FDA classified the action as a Class 1 recall, its most serious category. The agency’s own record shows the recall reached no confirmed injuries. It was closed as terminated in October 2023. No lawsuit, class action, or multidistrict litigation has been filed over the device. The matter is currently only at the attorney-investigation stage for patients who had an affected medical procedure.

Latest ACIST Kodama Catheter Lawsuit Updates

October 30, 2023: FDA Closes the Kodama Catheter Recall

The FDA‘s recall record shows the Kodama catheter correction, Recall Number Z-1161-2021, was marked Terminated on October 30, 2023 [1]. That closes the file on the correction ACIST Medical Systems began in January 2021. No lawsuit or multidistrict litigation was filed while the recall was open. None has been filed since the agency closed the file.

March 4, 2021: FDA Classifies the Recall as Class 1

The FDA posted the Kodama catheter recall as a Class 1 action on March 4, 2021. That is the agency’s most serious category. ACIST’s own manufacturing-line testing had found a damaged O-ring in an unexpected section of the catheter. The FDA logged the action as Recall Number Z-1161-2021. Its Recall Event ID is 87254. Both numbers appear in the agency’s public device-recall database, where anyone can look up the case online.

January 22, 2021: ACIST Notifies Customers and Begins the Recall

ACIST Medical Systems sent an “URGENT: MEDICAL DEVICE RECALL” letter and response form to customers on January 22, 2021. That is the date the FDA’s record lists as when the firm began the correction. Customers were told to check their inventory. They had to record the quantity of each recalled Kodama lot. Then they were to pull those lots from use and return the devices to ACIST using a prepaid label.

What Is the ACIST Kodama Catheter?

The FDA classifies the Kodama Intravascular Ultrasound Catheter as an intravascular ultrasound catheter, product code OBJ. The agency defines it as a device used “for intracardiac and intraluminal visualization of cardiovascular anatomy and physiology” [2]. In practice, it is a catheter fitted with ultrasound sensors. The sensors work with an imaging system, the ACIST HDi System. Together they display an ultrasound picture from inside a blood vessel during a procedure.

Who May Be Affected?

You may be affected if you had a coronary or peripheral intravascular ultrasound procedure with a Kodama catheter, model number 017788 or 018125. That applies at a facility that received one of the 13 recalled lot codes. The FDA’s record shows those lots reached hospitals in 19 U.S. states and in India, Italy, Japan, Poland, and the United Arab Emirates. That was before ACIST’s January 2021 recall notice went out to hospitals and clinics. Whether your circumstances support a claim takes an individual legal review of your procedure records, the treating facility, and the specific lot used. No two patient histories are identical.

Reported Injuries or Damages

The FDA’s own recall record states there were no related field reports. It also found no evidence or report of patient injury or adverse health consequence tied to the O-ring defect. The recall addressed a possible risk. A damaged O-ring fragment larger than 200 microns could break free and flush into a patient’s artery during use. A report citing the FDA’s warning letter said that fragment could cause vessel blockage, heart attack, arrhythmia, or stroke [3]. No complaint or lawsuit has alleged that a patient was harmed by the recalled catheter. A recall can exist based on a manufacturing defect alone, before anyone reports being hurt.

Recall and Regulatory Background

ACIST’s Kodama catheter correction carries FDA Recall Number Z-1161-2021. Thirteen lot codes were pulled, covering 1,185 units total. O-rings inside some of those catheters were found damaged during factory checks.

Evidence to Preserve

If you believe a coronary or peripheral procedure involved a recalled Kodama catheter, keep the following records so a lawyer can review your circumstances:

• The procedure report or hospital discharge summary that names the device model and the specific lot number used during your procedure
• Hospital billing records, or the device identification label or sticker that was placed in your medical chart after the procedure
• Post-procedure imaging, physician notes, or any written record of a device malfunction reported by staff during the procedure itself
• Current contact information for the facility, the treating physician, and any other staff member who performed or assisted with the procedure

These records let a lawyer confirm whether the lot used matches the FDA’s list of recalled Kodama lots before advising on any next step.

Filing Deadlines

Deadlines for filing a product liability claim come from each state’s own law, not from the recall or the FDA record. How much time you have depends on where you live and when your procedure and any related harm occurred. Some states start the clock at diagnosis rather than the procedure date. A missed deadline can sink an otherwise strong claim before a lawyer ever gets to argue the facts. Anyone concerned about a Kodama catheter procedure should talk with a lawyer promptly.

Frequently Asked Questions

What Is Driving the ACIST Kodama Catheter Lawsuit Investigation?

Attorneys are looking into a potential ACIST Kodama catheter lawsuit because the device’s O-ring could shed a fragment during a procedure. The catheter cleared the FDA under 510(k) Number K193183 before the same product line was later hit with the 2021 recall.

Were Any Injuries Reported from the ACIST Kodama Catheter Recall?

No injuries connected to the ACIST Kodama catheter recall have been confirmed. That finding held through the nearly three years the correction stayed open. It ran from ACIST’s January 2021 notice to customers until the FDA closed the file in October 2023.

Is the ACIST Kodama Catheter Recall Still Active?

No, the ACIST Kodama catheter recall is not still active. The FDA closed the correction, Recall Number Z-1161-2021, in October 2023. That correction was tied to ACIST’s manufacturing site in Eden Prairie, Minnesota (FEI Number 3001726808).

Has an ACIST Kodama Catheter Lawsuit or MDL Been Filed?

No ACIST Kodama catheter lawsuit or MDL has been filed as of late September 2026. Court and multidistrict-litigation records were checked specifically for this device. No matching case exists, so the matter remains an attorney investigation only.

What Should I Do If I Had a Procedure with an ACIST Kodama Catheter?

If you had a procedure with an ACIST Kodama catheter, start by asking your hospital’s risk-management office to confirm the lot number used. ACIST’s own recall notice routed lot returns through Stericycle at 877-576-9382, a detail your hospital’s supply team may still have on file.

Can I File an ACIST Kodama Catheter Lawsuit Without a Confirmed Injury?

Filing an ACIST Kodama catheter lawsuit without a confirmed injury remains untested. No case against this device has been filed at all, injured or not. The FDA’s separate Class 2 rating for this catheter type says nothing about the 2021 recall or any specific harm.

References

1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=185616
2. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=OBJ
3. https://www.medicaltubingandextrusion.com/fda-issues-class-i-recall-of-acist-kodama-intravascular-ultrasound-catheter/