ICU Medical Cogent Hemodynamic Monitoring System — Class II medical device recall Z-1835-2020
Terminated recall by ICU Medical, Inc., reported 2020-05-06, distributed nationwide. Firm identified several software issues through internal testing of its Cogent Hemodynamic Monitoring System.
| Recall number | Z-1835-2020 |
|---|---|
| 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 | 2019-07-12 |
| Classified | 2020-04-30 |
| Reported by FDA | 2020-05-06 |
| Terminated | 2023-05-10 |
| Distributed | Nationwide (US) |
| Quantity | 83 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00840619079499 |
| Model numbers | 58400-000 |
Product
ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-000, UDI: (01)00840619079499
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.
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-1835-2020. 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.