ICU Medical Cogent Hemodynamic Monitor Shows Incorrect Cardiac Output After Calibration
ICU Medical recalls Cogent Hemodynamic Monitoring System due to potential software issue causing incorrect continuous cardiac output readings after PulseCO calibration. Affected units may display wrong cardiac output values.
Lower-risk recall
Due to a potential software issue, the display may show the incorrect continuous cardiac output (CCO) values after PulseCO calibration.
Contact the company
What happened, in plain English
ICU Medical is recalling its Cogent Hemodynamic Monitoring System because a software issue might cause it to show incorrect continuous cardiac output (CCO) values after PulseCO calibration. This could lead to inaccurate patient monitoring during critical care. Read more at govinfonow.com/recall/63955-icu-medical-cogent-hemodynamic-monitor-shows-incorrect-cardiac-output-after.
Source Summary by GovInfoNow · govinfonow.com/recall/63955-icu-medical-cogent-hemodynamic-monitor-shows-incorrect-cardiac-output-after · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0859-2021
Cite this page
“ICU Medical Cogent Hemodynamic Monitor Shows Incorrect Cardiac Output After Calibration.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63955-icu-medical-cogent-hemodynamic-monitor-shows-incorrect-cardiac-output-after. Based on FDA recall #Z-0859-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0859-2021%22&limit=1).
Why it’s dangerous
The software issue can cause the device to display incorrect continuous cardiac output values after PulseCO calibration. This might lead to improper patient treatment decisions if healthcare providers rely on the inaccurate readings.
Who’s affected
Healthcare providers using the Cogent system for patient cardiac monitoring. Patients receiving critical care monitoring with this device may be at risk of inaccurate readings.
How to tell if you have this one
The Cogent Hemodynamic Monitoring System with serial numbers listed in the recall notice. The product was sold with specific list numbers and item codes.
- Brand
ICU Medical- Category
Medical device
What to do — step by step
Check Device Serial Number
Look for the serial number on your device, which should match one of the listed numbers in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 19 states.
FDA distribution: “U.S. Nationwide distribution including in the states of AL, AR, CA, CO, FL, IL, KY, MD, ME, MI, NC, NJ, OH, PA, TN, TX, VT, WA and WI. O.U.S.: None” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arkansas, California, Colorado, Florida, Illinois, Kentucky, Maine, Maryland, Michigan, New Jersey, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, Vermont, Washington, Wisconsin.
Recall timeline
FDA terminated this recall 2.4 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0859-2021 (November 9, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0859-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.