ICU Medical 52516Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840619060305), received between Dec 7, 2017 and Sep 8, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Calibration Error” (1 report).

5 other recalls cover devices cleared under the same FDA submission (K091268); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE EVENT INVOLVED A TRIOX¿ SVO2/CCO PA CATHETER, 8F, 110CM, J-TIP, LF WHERE IT WAS REPORTED THAT A TRIOX SVO2/CCO PA CATHETER IS UNABLE TO READ ACCURATE CARDIAC OUTPUT ON COGENT CCO MONITOR OR MANUAL THERMODILUTION WHICH COULD BE A THERMISTOR ISSUE. THE EVENT OCCURRED DURING CONTINUOUS CARDIAC OUTPUT MONITORING. THUS, THERE WAS PATIENT INVOLVEMENT, NO HUMAN HARM AND THERE WAS DELAY IN THERAPY REPORTED. THIS REPORT CAPTURES 2 OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22998248 ↗
• MalfunctionDec 7, 2017Calibration Error; Calibration Error

  OPTICAL MODULE OF CATHETER WAS NOT READING SVO2. THE CCO BOX WAS CHANGED OUT BUT SAME ISSUES OCCURRED. FACILITY REPORTS THAT THERE WAS A CRITICAL DELAY IN THERAPY AND MEDICAL INTERVENTION WAS REQUIRED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7095041 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K091268. One submission often covers many models, so check the product and lot details in each record.

• Z-1998-2020 · Jan 2, 2020 · Terminated
  Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for p
• Z-2000-2020 · Jan 2, 2020 · Terminated
  Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for p
• Z-1997-2020 · Jan 2, 2020 · Terminated
  Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for p
• Z-2001-2020 · Jan 2, 2020 · Terminated
  Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for p
• Z-1999-2020 · Jan 2, 2020 · Terminated
  Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for p