Hemodynamic monitoring system — Class II medical device recall Z-1775-2018
Terminated recall by ICU Medical, Inc., reported 2018-05-16, distributed in CA, FL, NC, NE, NY, WA. When continuous cardiac output monitoring with a pulmonary artery catheter is placed in the Pause mode, the ca
| Recall number | Z-1775-2018 |
|---|---|
| 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 | 2018-01-05 |
| Classified | 2018-05-09 |
| Reported by FDA | 2018-05-16 |
| Terminated | 2019-03-18 |
| Distributed | CA, FL, NC, NE, NY, WA |
| Quantity | 36 devices |
| UPC / GTIN / UDI-DI | 00840619079499, 00840619079505 |
| Model numbers | 58401-000, 58403-000 |
Product
Hemodynamic monitoring system (HMS), comprised of a Patient Interface Module (Part Number 58401-000 and a User Interface Module (Part Number 58403-000). Intended for patients for whom the monitoring of continuous cardiac output is indicated for diagnostic and prognostic evaluation by a clinician in the hospital.
Reason for recall
When continuous cardiac output monitoring with a pulmonary artery catheter is placed in the Pause mode, the catheter thermal coil may continue while in pause mode.
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-1775-2018. 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.