ICU Medical, Inc.: Medical Device Recall in 2020 - (Recall #: Z-1835-2020)

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:

ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-000, UDI: (01)00840619079499

Product Classification:

Class II

Date Initiated: July 12, 2019

Date Posted: May 6, 2020

Recall Number: Z-1835-2020

Event ID: 85300

Reason for Recall:

Firm identified several software issues through internal testing of its Cogent Hemodynamic Monitoring System. These issues may result in inaccurate monitoring data, unit shutdown, and/or loss of display of a secondary parameter.

Status: Terminated

Product Quantity: 83 units

Code Information:

All serial numbers of Cogent HMS, PN 58400-000, PN 58400-000R (User Interface Module (UIM), PN 58403-000 and Patient Interface Module (PIM), PN 58401-000) with Software Versions 1.3.2.460 and prior are impacted.

Distribution Pattern:

US Nationwide Distribution in the states of FL, WI, NY, NC, VT, IL, MD, CA, NE, WA OUS: None

Voluntary or Mandated:

Voluntary: Firm initiated