CLASS II Device recall · Reported 6 May 2020 · FDA Enforcement Report

Cogent Hemodynamic Monitoring System, Cogent recalled by ICU Medical

ICU Medical is recalling Cogent Hemodynamic Monitoring System, Cogent, distributed nationwide in the US. The recall was initiated on 12 Jul 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll 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.

Quantity recalled83 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1835-2020
FDA event ID: 85300
Recalling firm: ICU Medical, San Clemente, CA
Classification: Class II
Status: Terminated
Recall initiated: 12 Jul 2019
FDA classified: 30 Apr 2020
Reported: 6 May 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Patient Monitors

Timeline

12 Jul 2019	Recall initiated by company
30 Apr 2020	Classified by FDA	+293 days
6 May 2020	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

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

Nationwide California Florida Illinois Maryland North Carolina Nebraska New York Vermont Washington Wisconsin

Questions about this recall

Why was it recalled?

Which lots are affected?

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.

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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