ICU Medical 41231-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840619043681), received between Sep 11, 2024 and Mar 21, 2025 — classified as 2 malfunctions.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2025Material Rupture; Material Rupture

  A COMPLAINT WAS RECEIVED REGARDING A TD TORQUE-LINE CATHETER, 7F, 4 LUMEN 110 CM, LF THAT EXPERIENCED CRACKING AND RUPTURE. THE REPORTER STATED THAT THEY USE THIS PRODUCT KNOWING THAT THE WORST-CASE SCENARIO IS THAT THE BALLOON WILL RUPTURE WHEN INFLATED AND ONLY USE THIS PRODUCT IN PATIENTS THAT ABSOLUTELY NEED IT BECAUSE OF A LATEX ALLERGY. HOWEVER, THEY HAVE NEVER SEEN A BALLOON BREAK INTO FRAGMENTS. THE EVENT DATE WAS ON (B)(6) 2025. THERE WAS PATIENT INVOLVEMENT, THERE WAS A DELAY IN THE CRITICAL THERAPY WHEN THE PROBLEM WAS NOTED, THERE WAS NO SERIOUS DETERIORATION IN THE STATE OF HEALTH OR DEATH OF PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21660260 ↗
• MalfunctionSep 11, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED SWAN DEVICE GENERATED A BLOOD LEAK DURING PATIENT USE. THE REPORT STATES THAT "THE ANESTHESIOLOGIST NOTICED A POOL OF BLOOD ON THE FLOOR IN A SPOT THAT WOULDN'T USUALLY HAVE IT. AFTER ABOUT AN HOUR INTO THE CASE, THE PHYSICIAN TRACED IT TO THE THERMISTOR CONNECTION PORT." THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20196661 ↗

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-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-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-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-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