ICU Medical, Inc. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
ICU Medical, Inc.
Lot Codes / Batch Numbers
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.
Products Sold
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.
ICU Medical, Inc. is recalling The Cogent Hemodynamic Monitoring System. REF58400-000, GTIN 00840619099459; REF 58400-000R, GTIN 00 due to Firm identified software issues which leads to the patient ID and patient information not being stored in the system.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Firm identified software issues which leads to the patient ID and patient information not being stored in the system.
Recommended Action
Per FDA guidance
On 14 February 2020, the firm sent notification of the recall to direct consignees of record. Delivery will be confirmed via traceable mailing. All consignees who further distributed the product were asked to notify their customers
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026