ICU Medical 58400-000RRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887709094314), received between Aug 23, 2024 and Aug 23, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Excessive Heating” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K152006); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 23, 2024Excessive Heating; Excessive Heating

  THE EVENT INVOLVED A COGENT HEMODYNAMIC MONITORING SYSTEM, REFURBISHED WHERE THE CUSTOMER REPORTED THAT THE DISPLAY DOES NOT COME ON- IT ONLY SHOWED GRAY SCREEN AND THEN GOES BLACK. IT WAS ALSO STATED THAT THE WHOLE UNIT IS PUTTING OFF AN EXCESSIVE AMOUNT OF HEAT. THIS WAS A LOANER THAT THEY RECEIVED LAST WEEK AND WAS GENERATING AN EXCESSIVE AMOUNT OF HEAT. THERE WAS UNKNOWN PATIENT INVOLVEMENT, UNKNOWN HUMAN HARM AND UNKNOWN DELAY OF THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20049358 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K152006. One submission often covers many models, so check the product and lot details in each record.

• Z-0859-2021 · Nov 9, 2020 · Terminated
  icumedical Cogent" Hemodynamic Monitoring System - Product Usage: intended for patients for whom the monitoring of continuous cardiac output and calculated hemodynamic parameters i
• Z-1927-2020 · Feb 14, 2020 · Terminated
  The Cogent Hemodynamic Monitoring System. REF58400-000, GTIN 00840619099459; REF 58400-000R, GTIN 0087709094314; REF 58403, GTIN 00840619079505; REF 58401, GTIN 00840619079499 - Pr
• Z-1835-2020 · Jul 12, 2019 · Terminated
  ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-000, UDI: (01)00840619079499
• Z-1775-2018 · Jan 5, 2018 · Terminated
  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