Acist Medical Systems recalls Kodama Intravascular Ultrasound Catheters with damaged o-rings that could flush out of the catheter during use. No injuries reported.
Test results from the manufacturing line found a piece of damaged o-ring in an unexpected section of the catheter. Further testing indicated that pieces (>200 micron) of damaged o-ring had the potential to be flushed out of the catheter. ACIST is confirming the source of the failure mode to assure the quality and reliability of the Kodama catheter. There have been no related field reports related to this incident, nor any evidence or report of patient injury or adverse health consequence.
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📍Recalling firmAcist Medical Systems7905 Fuller Rd · Eden Prairie, MN 55344-2137
✎ GovInfoNow plain-language explainer
Acist Medical Systems is recalling Kodama Intravascular Ultrasound Catheters due to a damaged o-ring that could flush out of the catheter during use. This poses a risk of potential blockage or injury during medical procedures, though no injuries have been reported. Read more at govinfonow.com/recall/63356-acist-kodama-ultrasound-catheter-recall-damaged-o-ring-risk.
“Acist Kodama Ultrasound Catheter Recall: Damaged O-Ring Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63356-acist-kodama-ultrasound-catheter-recall-damaged-o-ring-risk. Based on FDA recall #Z-1161-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1161-2021%22&limit=1).
The FDA announced on Jan. 22, 2021, that Acist Medical Systems is recalling the ACIST Kodama Intravascular Ultrasound Catheter due to potential o-ring fragments flushing from the device. The recall affects 1,185 units distributed worldwide.
Distribution: Worldwide, including US states AL, AR, CA, CO, FL, IL, KS, KY, LA, MD, MI, MO, NC, NJ, NY, OK, PA, RI, TN and countries India, Italy, Japan, Poland, United Arab Emirates
The hazard
The FDA said test results from the manufacturing line found a piece of damaged o-ring in an unexpected section of the catheter. Further testing indicated that pieces greater than 200 microns of damaged o-ring had the potential to be flushed out of the catheter.
Context
GovInfoNow's records show other recent recalls of similar products include Medline ACUSON AcuNav Ultrasound Catheters Recall: Risk of Infection from Reprocessed Units (2025-12-22), Stryker CS Uni-Directional w Auto ID Catheter Recall: Incomplete Sterile Seals (2026-04-10), and ReCor Paradise Ultrasound Renal Denervation System Recall: Nonconforming Product Hazard (2026-01-29).
How to tell if you have this one
Check for model numbers 017788 or 018125 (Japan only) or lot codes listed in the recall notice. The catheter is part of the ACIST HDi System used for ultrasound imaging of blood vessels.
Brand
Acist Medical Systems
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Review the model number and lot codes listed in the recall notice to confirm if your catheter is affected.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 19 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide - US Nationwide Distribution in the states of AL, AR, CA, CO, FL, IL, KS, KY, LA, MD, MI, MO, NC, NJ, NY, OK, PA, RI, TN; In the countries of India, Italy, Japan, Poland, and United Arab Emirates.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arkansas, California, Colorado, Florida, Illinois, Kansas, Kentucky, Louisiana, Maryland, Michigan, Missouri, New Jersey, New York, North Carolina, Oklahoma, Pennsylvania, Rhode Island, Tennessee.
Recall timeline
FDA terminated this recall 2.8 years after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1161-2021 (January 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1161-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.