ICU Medical 41233-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840619043735), received between Mar 22, 2025 and May 8, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (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.

• MalfunctionMay 8, 2025Burst Container or Vessel; Burst Container or Vessel

  THE EVENT INVOLVED A TD CATHETER, 8F, 5 LUMEN, 110 CM, RA/RA, HEPARIN COATED, LF WHERE THE CUSTOMER REPORTED THAT THEY WERE ATTEMPTING TO REPOSITION PULMONARY ARTERY CATHETER (INCLUDING BALLOON INFLATION) AT THE BEDSIDE DUE TO WAVEFORM ABNORMALITY. THE CATHETER WAS NOT ABLE TO BE REPOSITIONED CORRECTLY AND COILED IN THE PATIENT'S HEART WHICH WAS CONFIRMED VIA CHEST X-RAY. THE CUSTOMER ATTEMPTED REPOSITIONING THE PULMONARY ARTERY CATHETER (PAC) UNDER FLUOROSCOPY, THEY COULD NOT VISUALIZE BALLOON, SO THE CATHETER WAS REMOVED AND REPLACED AND UPON VISUAL INSPECTION THE BALLOON RUPTURED. THERE WAS PATIENT INVOLVEMENT BUT HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21990804 ↗
• MalfunctionMar 22, 2025Material Rupture; Material Rupture

  A COMPLAINT WAS RECEIVED REGARDING TD CATHETER, 8F, 5 LUMEN, 110 CM, RA/RA, HEPARIN COATED, LF THAT EXPERIENCED BALLOON RUPTURE. IT WAS STATED IN THE REPORT THAT THE PA CATHETER BALLOON RUPTURED WHILE IN THE PATIENT. THE SAMPLE IS AVAILABLE FOR EVALUATION. THE EVENT OCCURRED ON (B)(6) 2025 DURING USE. THERE WAS PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21673026 ↗

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-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-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-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