# FDA recall Z-1161-2021

> **Acist Medical Systems** · Class I · device recall initiated 2021-01-22.

## 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.

## 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.

## Key facts

- **Recall number:** Z-1161-2021
- **Recalling firm:** Acist Medical Systems
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-01-22
- **Report date:** 2021-03-10
- **Termination date:** 2023-10-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Eden Prairie, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1161-2021

## Citation

> AI Analytics. FDA recall Z-1161-2021. Retrieved 2026-09-04 from https://api.ai-analytics.org/recall/Z-1161-2021. Source: US FDA. Licensed CC0.

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