Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The Cogent Hemodynamic Monitoring System. REF58400-000 Recalled by ICU Medical, Inc. Due to Firm identified software issues which leads to the...
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
The Cogent Hemodynamic Monitoring System. REF58400-000, GTIN 00840619099459; REF 58400-000R, GTIN 0087709094314; REF 58403, GTIN 00840619079505; REF 58401, GTIN 00840619079499 - 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. The target population includes Critical Care Patients, Trauma Patients, and Cardiac Surgery Patients.
Quantity: 123 units
Why Was This Recalled?
Firm identified software issues which leads to the patient ID and patient information not being stored in the system.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
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