Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported March 10, 2021
ACIST Kodama Intravascular Ultrasound Catheter The Kodama Intravascular Ultrasound Catheter is a component of the ACIST HDi System. The ACIST HDi System is intended to be used for ultrasound examination of coronary and peripheral intravascular pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures. The ACIST Kodama Intravascular Ultrasound Catheter is intended for use with the ACIST HDi System.
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…
Acist Medical Systems recalled ACIST Kodama Intravascular Ultrasound Catheter The Kodama Intravascular Ultrasound Ca… - a critical-severity action.
ACIST Kodama Intravascular Ultrasound Catheter The Kodama Intravascular Ultrasound Ca… was recalled by Acist Medical Systems in March 10, 2021. Reason: Test results from the manufacturing line found a piece of damaged o-ring in an unexpected section of the cath…. Check the official notice for the remedy. Verify recall #Z-1161-2021 with the FDA Devices before acting.
The recall
Acist Medical Systems issued this critical-severity FDA Devices recall-Test results from the manufacturing line found a piece of damaged o-ring in an unexpected section of the cath….
- Critical
- severity level
- 1K units
- affected scope
- Class I
- classification
- March 10, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1161-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1161-2021) was formally reported on March 10, 2021, with the manufacturer initiating the action on January 22, 2021. It is classified under Critical severity (Class I), with a current status of Terminated. Acist Medical Systems is listed as the recalling firm, operating out of Eden Prairie, MN. Federal records list the affected scope as 1185 units.
The documented reason for this recall is: 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 ou… Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1185 units
Related Recalls
6
3 from same agency
Product description
ACIST Kodama Intravascular Ultrasound Catheter The Kodama Intravascular Ultrasound Catheter is a component of the ACIST HDi System. The ACIST HDi System is intended to be used for ultrasound examination of coronary and peripheral intravascular pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures. The ACIST Kodama Intravascular Ultrasound Catheter is intended for use with the ACIST HDi System.
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-1161-2021 |
| Date reported | March 10, 2021 |
| Date initiated | January 22, 2021 |
| Recalling firm | Acist Medical Systems |
| Firm location | Eden Prairie, MN |
| Affected scope | 1185 units |
| 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1161-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
ACIST Kodama Intravascular Ultrasound Catheter The Kodama Intravascular Ultrasound Catheter is a component of the ACIST HDi System. The ACIST HDi System is intended to be used for ultrasound examination of coronary and peripheral intravascular pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures. The ACIST Kodama Intravascular Ultrasound Catheter is intended for use with the ACIST HDi System.. Recalled by Acist Medical Systems. Units affected: 1185 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 10, 2021. Severity: Critical. Recall number: Z-1161-2021.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1161-2021) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported March 10, 2021. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.