ICU Medical 41237-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840619043759), received between Dec 20, 2017 and Dec 20, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Inflation Problem” (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 20, 2017Inflation Problem; Inflation Problem

  COMPLAINT RECEIVED REPORTING BALLOON INFLATION FAILURE WITH ONE (1) 41237-06 TD TORQUE-LINE CATHETER, 8F, 5 LUMEN, 110 CM, RA/RA, HEPARIN COATED, LF. THE INITIAL INFORMATION RECEIVED REPORTS AT AN UNSPECIFIED TIME AFTER INSERTION THE CATHETER BALLOON FAILED TO MAINTAIN INFLATION. THE DEVICE WAS REMOVED AND REPLACED WITH NO FURTHER ISSUES ENCOUNTERED. THERE WERE NO REPORTED ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7136233 ↗

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-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
• 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