Bardex® I.C. Tiemann Model Coude Tip Foley Catheter 0103SI16Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741017131), received between Jan 22, 2020 and May 5, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).

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.

• MalfunctionMay 5, 2021Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE BALLOON OF THE FOLEY CATHETER POPPED AND OTHER ONE FELL OUT AND WOULD BECOME LOOSE WHILE THE PATIENT WAS MOVING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11777175 ↗
• MalfunctionMay 5, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE BALLOON OF THE FOLEY CATHETER POPPED AND OTHER ONE CATHETER FELL OUT. IT WOULD BECOME LOOSE WHILE THE PATIENT WAS MOVING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11777163 ↗
• MalfunctionJan 22, 2020Fluid/Blood Leak; Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PATIENT STATED THE FOLEY CATHETER WAS LEAKING. IT IS CURRENTLY UNKNOWN WHETHER THE CATHETER LEAKED WATER OR URINE.

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

  MAUDE report 9617670 ↗