ACIST Kodama Intravascular Ultrasound Catheter The Kodama… — Class I medical device recall Z-1161-2021
Terminated recall by Acist Medical Systems, reported 2021-03-10, distributed nationwide. Test results from the manufacturing line found a piece of damaged o-ring in an unexpected section of the cathe
| Recall number | Z-1161-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Acist Medical Systems, Eden Prairie, MN, United States |
| Recall initiated | 2021-01-22 |
| Classified | 2021-03-04 |
| Reported by FDA | 2021-03-10 |
| Terminated | 2023-10-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, IN, IT, JP, PL |
| Quantity | 1,185 units |
| Lot numbers | 00233370 |
| Model numbers | 017788, 018125 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1161-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.