FDA-Device2018-05-16Class II
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.
Hazard
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.
Sold states
Distributed to the states of CA, FL, NC, NE, NY, and WA.
Affected count
36 devices
Manufactured in
951 Calle Amanecer, N/A, San Clemente, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1775-2018More ICU Medical, Inc. recalls
- FDA-Device2026-07-22ICU Medical Plum Duo Infusion Pump recalled for potential overdose risk
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- FDA-Device2026-06-17ICU Medical Plum Duo Precision IV Pump recalled for missing soft limit alerts
- FDA-Device2026-06-17ICU Medical Plum Duo Infusion Pump recalled for missing soft limit alerts
- FDA-Device2026-06-17ICU Medical Plum Solo Precision IV Pump recalled for missed soft limit alerts
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