ICU Medical 52510Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840619059828), received between Dec 10, 2019 and Dec 10, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED BLOOD LOSS THAT OCCURRED DURING USE OF A TRIOX¿ SVO2/CCO PA CATHETER. IT WAS REPORTED THAT THE TRIOX CCO/SVO2 CATHETER WAS NO LONGER PROVIDING A CONTINUOUS CARDIAC OUTPUT (CCO) VALUE WHEN THE PATIENT CAME OFF BYPASS. BLOOD WAS DISCOVERED DRIPPING OUT OF THE THERMISTOR HUB WHEN THE THERMISTOR CABLE WAS REMOVED. THE EVENT OCCURRED DURING USE ON PATIENT FOR 3 HOURS. THE ISSUE WAS NOTICED WHEN THERE WASN'T A CCO VALUE ON THE MONITOR. NO ADVERSE EVENT OCCURRED.

  Patient problems: Blood Loss

  MAUDE report 9443391 ↗

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-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
• 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-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-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-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