# FDA recall Z-1775-2018

> **ICU Medical, Inc.** · Class II · device recall initiated 2018-01-05.

## Product

Hemodynamic monitoring system (HMS), comprised of a Patient Interface Module (Part Number 58401-000 and a User Interface Module (Part Number 58403-000).    Intended for patients for whom the monitoring of continuous cardiac output is indicated for diagnostic and prognostic evaluation by a clinician in the hospital.

## Reason for recall

When continuous cardiac output monitoring with a  pulmonary artery catheter is placed in the  Pause  mode,  the catheter thermal coil may continue while in pause mode.

## Distribution

Distributed to the states of CA, FL, NC, NE, NY, and WA.

## Key facts

- **Recall number:** Z-1775-2018
- **Recalling firm:** ICU Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-01-05
- **Report date:** 2018-05-16
- **Termination date:** 2019-03-18

- **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-1775-2018

## Citation

> AI Analytics. FDA recall Z-1775-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1775-2018. Source: US FDA. Licensed CC0.

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