ICU Medical 41231-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00840619043674), received between Oct 16, 2024 and Oct 16, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “No Device Output” (3 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 16, 2024No Device Output; No Device Output

  IT WAS REPORTED THAT A TD TORQUE-LINE CATHETER, 7F, 4 LUMEN, 110 CM WAS FOUND TO PROVIDE INACCURATE READINGS DURING PATIENT USE. THE REPORTER STATED THAT AFTER THE FIRST THERMODILUTION CATHETER FAILED THE PHYSICIAN ATTEMPTED TO OBTAIN CARDIAC OUTPUTS ONCE AGAIN WITH A NEW THERMODILUTION CATHETER AND CABLE. STILL UNABLE TO OBTAIN OUTPUTS BECAUSE TEMPERATURE READINGS WERE NOT WITHIN RANGE. IT WAS ALSO STATED THAT THE CASE ENDED BECAUSE NO CARDIAC OUTPUTS COULD BE OBTAINED, UNABLE TO CALCULATE VALVE AREA TO EVALUATE FOR AORTIC STENOSIS AND POSSIBLE NEED FOR VALVE REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20468100 ↗
• MalfunctionOct 16, 2024No Device Output; No Device Output

  IT WAS REPORTED THAT A TD TORQUE-LINE CATHETER, 7F, 4 LUMEN, 110 CM WAS FOUND TO GIVE INACCURATE READINGS. THE REPORTER STATED THAT DURING THE CARDIAC CATHETERIZATION PROCEDURE, THE PHYSICIAN HAD A DUAL-LUMEN PIGTAIL IN PLACE. WAVEFORMS DISPLAYED ON THE HEMODYNAMIC SYSTEM ARE NOT ACCURATE. THE CATHETER WAS REMOVED AND DISCOVERED TO HAVE HAD A HOLE. IT WAS ALSO STATED THAT THE DEVICE WAS IMMEDIATELY REMOVED FROM THE TABLE AND A NEW DUAL-LUMEN PIGTAIL CATHETER WAS PROVIDED. THE PHYSICIAN WAS UNABLE TO PROCEED WITH THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20468005 ↗
• MalfunctionOct 16, 2024No Device Output; No Device Output

  IT WAS REPORTED THAT A TD TORQUE-LINE CATHETER, 7F, 4 LUMEN, 110 CM WAS FOUND TO PROVIDE INACCURATE READINGS DURING PATIENT USE. THE REPORTER STATED THAT USING THE NEW ICU MEDICAL THERMODILUTION CATHETERS DURING A PROCEDURE, WAS UNABLE TO OBTAIN ACCURATE WAVEFORM DESPITE TROUBLESHOOTING (I.E. NEW TRANSDUCER AND CHANGING CHANNEL CABLES). IT WAS ALSO STATED THAT "ATTEMPTED TO USE ANOTHER PRESSURE CABLE, BUT STILL UNRELIABLE WAVEFORMS NOTED. REPLACED TRANSDUCER CABLE OFF THE MANIFOLD, BUT STILL OBTAINED INACCURATE WAVEFORM READINGS. THE PHYSICIAN WAS NOT ABLE TO COMPLETE THE PROCEDURE AND IS QUESTIONING THE RESULTS. THE REPORTER STATED, "TO MY KNOWLEDGE, THE READING WASN¿T CORRESPONDING TO THE PATIENT'S CLINICAL STATUS AT THE TIME OF USE. THE PATIENT WAS NOT AFFECTED DURING THE USE OF THE PRODUCT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20467754 ↗

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-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
• 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-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