icumedical Cogent" Hemodynamic Monitoring System — Class II medical device recall Z-0859-2021
Terminated recall by ICU Medical, Inc., reported 2021-01-20, distributed nationwide. Due to a potential software issue, the display may show the incorrect continuous cardiac output (CCO) values a
| Recall number | Z-0859-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ICU Medical, Inc., San Clemente, CA, United States |
| Recall initiated | 2020-11-09 |
| Classified | 2021-01-14 |
| Reported by FDA | 2021-01-20 |
| Terminated | 2023-04-19 |
| Distributed | Nationwide (US) |
| Quantity | 220 units |
| Reason classes | software |
| Serial numbers | 140123, 140137, 140371, THS101345, THS901589, THS901630, THS901633, TSFA01656, TSFA01657, TSFA01659, TSFA01661, TSFA01665, TSFA01666, TSFA01667, TSFA01677, TSFA01681, TSFA01683, TSFA01684, TSFA01686, TSFA01687, TSFA01695, TSFA01696, TSFA01697, TSH101337, TSH101338 and 475 more |
| Model numbers | 58400-000, 58400-000R, 58403-000 |
Product
icumedical Cogent" Hemodynamic Monitoring System - 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.
Reason for recall
Due to a potential software issue, the display may show the incorrect continuous cardiac output (CCO) values after PulseCO calibration.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0859-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.