# FDA recall Z-0859-2021

> **ICU Medical, Inc.** · Class II · device recall initiated 2020-11-09.

## Product

icumedical Cogent" Hemodynamic Monitoring System - Product Usage: intended for patients for whom the monitoring of continuous cardiac output and calculated hemodynamic parameters is indicated for diagnostic and prognostic evaluation by a clinician.

## Reason for recall

Due to a potential software issue, the display may show the incorrect continuous cardiac output (CCO) values after PulseCO calibration.

## Distribution

U.S. Nationwide distribution including in the states of AL, AR, CA, CO, FL, IL, KY, MD, ME, MI, NC, NJ, OH, PA, TN, TX, VT, WA and WI. O.U.S.: None

## Key facts

- **Recall number:** Z-0859-2021
- **Recalling firm:** ICU Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-11-09
- **Report date:** 2021-01-20
- **Termination date:** 2023-04-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Clemente, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0859-2021

## Citation

> AI Analytics. FDA recall Z-0859-2021. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-0859-2021. Source: US FDA. Licensed CC0.

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