Bardia 123514CERecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00801741171673), received between Dec 4, 2018 and Aug 21, 2026 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (7 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50377863 ↗
• MalfunctionApr 25, 2026Material Rupture

  IT WAS REPORTED THAT THE PATIENT CALLED SAYING HER FOLEY CATHETER CAME OUT. WHEN CUSTOMER WENT TO CHECK, THEY SAW THE FOLEY ON THE FLOOR AT THE BEDSIDE. AFTER INSPECTING THE CATHETER CLOSELY, IT LOOKS LIKE THE BALLOON HOLDING IT IN PLACE HAD BURST RESULTING IN THE CATHETER SLIPPING OUT. NEW FOLEY WAS INSERTED WHEN PATIENT WAS BACK IN BED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24993084 ↗
• MalfunctionMar 30, 2026Material Puncture/Hole

  IT WAS REPORTED THAT DURING USE THE FOLEY CATHETER BALLON HAD WATER LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24714083 ↗
• MalfunctionMar 18, 2026Material Rupture

  IT WAS REPORTED THAT FOLEY CATHETER BALLOON GOT RUPTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24630984 ↗
• MalfunctionJan 7, 2026Material Rupture

  IT WAS REPORTED THAT, FOLEY CATHETER BALLOON WAS RUPTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23999516 ↗
• MalfunctionDec 5, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT, BALLOON WAS RUPTURED OF THE FOLEY CATHETER DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23728960 ↗
• MalfunctionNov 3, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT DURING USE, THERE WAS NO OPENING AT THE FRONT END OF THE FOLEY CATHETER AND URINE COULD NOT BE DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23455599 ↗
• MalfunctionOct 15, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING USE, FOLEY CATHETER RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23301549 ↗
• MalfunctionJul 2, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT 2 PIECES OF FOLEY CATHETER WERE DEFECTIVE, THERE WAS NO URINE OUT FLOW. PATIENT WAS EXPOSED TO URINE. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Exposure to Body Fluids

  MAUDE report 22384640 ↗
• InjuryFeb 28, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT AFTER USE, THE WALL OF THE URINARY FOLEY CATHETER WAS LEAKED. PATIENT WAS EXPOSED TO URINE. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Exposure to Body Fluids

  MAUDE report 21490850 ↗
• MalfunctionAug 28, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THEY CHECKED FOLEY PLACE, FOUND THAT FOLEY CATHETER BALLOON WAS RUPTURED AND FOLEY SLIDE OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20087986 ↗
• MalfunctionJun 19, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT URINE DID NOT DRAIN AFTER CATHETERIZATION OF FOLEY CATHETER AND UNABLE TO FLUSH. NURSE NOTED THAT THE EYELET HAD NO HOLE, AND THE OUTLET LOOKS PIN HOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19567281 ↗
• MalfunctionDec 6, 2018Difficult to Remove; Deflation Problem; Fluid/Blood Leak; Difficult to Remove

  IT WAS REPORTED THAT THE CATHETER LEAKED. THE CATHETER WAS INFLATED WITH 10ML BUT 2 ML LEAKED ON THE SIDE. IT WAS ALSO DIFFICULT TO DEFLATE THE CATHETER.

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

  MAUDE report 8137443 ↗
• MalfunctionDec 4, 2018Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE CATHETER LEAKED. THE CATHETER WAS INFLATED WITH 10ML BUT 2 ML WAS LEAKING ON THE SIDE. IT WAS ALSO DIFFICULT TO DEFLATE THE CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8128379 ↗