CLASS II Device recall · Reported 13 May 2020 · FDA Enforcement Report

The Cogent Hemodynamic Monitoring System recalled by ICU Medical

ICU Medical is recalling The Cogent Hemodynamic Monitoring System, distributed nationwide in the US. The recall was initiated on 14 Feb 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll 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.

Quantity recalled123 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-1927-2020
FDA event ID: 85329
Recalling firm: ICU Medical, San Clemente, CA
Classification: Class II
Status: Terminated
Recall initiated: 14 Feb 2020
FDA classified: 7 May 2020
Reported: 13 May 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Patient Monitors

Timeline

14 Feb 2020	Recall initiated by company
7 May 2020	Classified by FDA	+83 days
13 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 software issues which leads to the patient ID and patient information not being stored in the system.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

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

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

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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.

Where was it sold?

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

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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