ICU Medical 41232-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840619043704), received between May 7, 2025 and May 7, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Air/Gas in Device” (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.

• InjuryMay 7, 2025Material Rupture; Air/Gas in Device; Material Rupture; Air/Gas in Device

  THE EVENT INVOLVED A TD CATHETER, 8F, 5 LUMEN, 110CM, RA/RV, HEPARIN COATED, LF WHERE THE CUSTOMER STATED THAT THE REGISTERED NURSE (RN) COLLECTED MORNING PA NUMBERS AROUND 06:30. UPON INFLATION OF THE BALLOON, THE CATHETER ACHIEVED ONLY A PARTIAL WEDGE. AFTER RELEASING THE INFLATION VALVE, THE BALLOON DID NOT PASSIVELY DEFLATE. THE RN WAS ABLE TO MANUALLY ASPIRATE THE AIR FROM THE BALLOON AND SUBSEQUENTLY NOTIFIED THE CHARGE RN FOR FURTHER EVALUATION. WHEN THE CHARGE RN INSPECTED THE CATHETER, IT APPEARED TO BE INTACT AND INFLATED THE BALLOON. WHEN THE CHARGE RN REINSPECTED THE CATHETER, RN NOTED BLOOD BACK FLOWING INTO THE SYRINGE. MD AND CCR FELLOW MD WAS IMMEDIATELY NOTIFIED OF THE SUSPECTED BALLOON RUPTURE AND IT WAS PROMPTLY REMOVED. A CHEST X-RAY WAS ALSO ORDERED AND PERFORMED. THE PATIENT DENIED ANY SHORTNESS OF BREATH AND APPEARED TO BE IN HIS USUAL STATE OF HEALTH. THERE WAS PATIENT INVOLVEMENT, UNKNOWN DELAY IN THERAPY REPORTED, NO HUMAN HARM THOUGH THERE WAS A NEED FOR INCREASED MONITORING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21977640 ↗

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-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