ICU Medical, Inc.: Medical Device Recall in 2020 - (Recall #: Z-1927-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: February 14, 2020

Date Posted: May 13, 2020

Recall Number: Z-1927-2020

Event ID: 85329

Reason for Recall:

Firm identified software issues which leads to the patient ID and patient information not being stored in the system.

Status: Terminated

Product Quantity: 123 units

Code Information:

All serial numbers of Cogent HMS, List Number(s): 58400-000; 58400-000R; 58403-000; 58401-000 with Software Versions 1.3.3.42 and prior are impacted.

Distribution Pattern:

US Nationwide distribution including in the states of AR, CA, FL, IL, MD, NC, NE, NY, TX, VT, WA and WI.

Voluntary or Mandated:

Voluntary: Firm initiated