Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Hemodynamic monitoring system (HMS) Recalled by ICU Medical, Inc. Due to When continuous cardiac output monitoring with a pulmonary...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact ICU Medical, Inc. directly.
Affected 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.
Quantity: 36 devices
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 6 states: CA, FL, NE, NY, NC, WA
About ICU Medical, Inc.
ICU Medical, Inc. has 592 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report