Bardex® I.C. Councill Model Foley Catheter 0196SI16Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741017018), received between Nov 9, 2023 and Apr 4, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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.

• MalfunctionApr 4, 2026Material Rupture

  IT WAS REPORTED BY THE CUSTOMER THAT THE BX INDWELLING CATHETER TWO WAY FIVE CUBIC CENTIMETER COUNCIL MODEL FOLEY BALLOON FAILED WHILE USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24784530 ↗
• MalfunctionDec 2, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT PROVIDER AND STAFF WERE TRYING TO REMOVE THE FOLEY CATHETER FROM A PATIENT AND WAS MET WITH RESISTANCE. IN ORDER TO TRY AND DEFLATE THE BALLOON THE DECISION WAS MADE TO CUT THE AIR VALVE ON THE OTHER END BUT STILL MET WITH RESISTANCE. WHEN THE DEVICE WAS FINALLY REMOVED THE BALLOON REMAINED FULLY INFLATED. AFTER HAVING THE DEVICE OVER THE WEEKEND AS THEY WERE TRYING TO GIVE IT TO SOMEONE THE BALLOON HAS FINALLY GONE DOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20818395 ↗
• MalfunctionNov 9, 2023Material Puncture/Hole; Material Split, Cut or Torn; Material Puncture/Hole; Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WAS A PIN HOLE NEAR THE HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18104513 ↗