ICU Medical 58400-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840619099459), received between Jul 24, 2024 and Jul 24, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Battery Problem” (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.

• MalfunctionJul 24, 2024Battery Problem; Battery Problem

  THE ORIGINAL EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A COGENT WHERE IT WAS REPORTED THE BASE ISN'T SHOWING CERTAIN VALUES, AND TSH900411 FOR THE SCREEN WHICH IS NOT BOOTING UP WITH ERROR. THE DEVICE WAS RETURNED FOR INVESTIGATION AND THE COMPLAINT WAS CONFIRMED OF THE TABLET NOT SHOWING VALUES. THE DEVICE FAILED VISUAL INSPECTION WITH A SWOLLEN BATTERY. THE DEVICE WAS UNABLE TO BE CHARGED THROUGH AN EXTERNAL SOURCE AND THE DISPLAY WAS NOT SHOWN. THE PROBABLE CAUSE OF THE BATTERY NOT ABLE TO BE CHARGED AND NO DISPLAY HAD OCCURRED DUE TO A DEAD BATTERY. THERE WAS NOT PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19816640 ↗

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