Bardia® Foley Catheter Silicone Coated 123518ARecalls & reported problems

Summary

The FDA's MAUDE database contains 153 adverse event reports that list this exact device (DI 00801741095108), received between Jun 5, 2017 and Jul 20, 2026 — classified as 14 injuries, 139 malfunctions.

The most frequently reported specific device problem is “Partial Blockage” (26 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 153 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25879622 ↗
• InjuryMar 13, 2026Difficult to Remove

  IT WAS REPORTED THAT ON (B)(6) 2026 PLACEMENT OF THE FOLEY CATHETER INITIATED. ON (B)(6) 2026 ATTEMPTED REMOVAL BUT THE DEVICE DID NOT FALL OUT. CUT THE VALVE SECTION, PASSED A GW THROUGH TO SECURE THE ROUTE, AND DRAINED STERILE WATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24595772 ↗
• MalfunctionDec 29, 2025Material Fragmentation; Nonstandard Device; Material Fragmentation; Nonstandard Device

  IT WAS REPORTED THAT DAMAGE TO THE FOLEY CATHETER INFLATION VALVE WAS NOTICED DURING USE ON A PATIENT, AND THE DEVICE WAS IMMEDIATELY STOPPED. IT WAS ALSO MENTIONED AS PLEASE INVESTIGATE WHETHER THE DAMAGE OCCURRED DURING THE MANUFACTURING PROCESS. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 23DEC2025, STATED THAT DURING USE THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23917358 ↗
• MalfunctionSep 23, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT CONTAMINANT PRESENT INSIDE THE STERILIZATION POUCH OF FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23123520 ↗
• MalfunctionJul 30, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT PATIENT WAS ON STRETCHER POST WAKE UP FROM KIDNEY TRANSPLANT WHEN FOLEY CATHETER WAS NOTED TO BE ON THE STRETCHER NOT INSERTED INTO THE PATIENT. THE FOLEY APPEARED TO BE DEFECTIVE UPON INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22665960 ↗
• MalfunctionJul 22, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT, THE PATIENT NOTICED A LEAK IN THE FOLEY CATHETER BALLOON ON THE WAY HOME AFTER CATHETERIZATION. UPON EXAMINATION, THE DOCTOR CONFIRMED THAT THE BALLOON WAS INDEED DAMAGED. THE DEFECTIVE PRODUCT WAS NOT RETAINED, AND A NEW SET WAS USED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22565798 ↗
• MalfunctionJul 1, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS IN THEIR HAND THAT HAD A DEFLATED BALLOON AND PULLED OUT BY PATIENT WITHOUT EFFORT OR PAIN. UPON INSPECTION THE FOLEY CATHETER 18F REGULAR TIP WAS INTACT, BUT THE BALLOON HAD RIPPED, AND A DEFINED SILICONE LINE INDICATED THAT THE BALLOON RIPPED AND DEFLATED INSIDE THE PATIENT. THERE WAS A NEED TO CHECK THE SUPPLIED CATHETERS IN ORDER NOT TO HAD SAME INCIDENTS. THE PATIENT WAS BED FAST AND HAD NOT BEEN NOTICED TO BE PULLING THE CATHETER INTENTIONALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22373272 ↗
• MalfunctionJun 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD THEIR CYSTOSTOMY FOLEY CATHETER WAS REPLACED IN THE MORNING AND THE CATHETER DISLODGED ON THE WAY HOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22296959 ↗
• MalfunctionMay 15, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE FOLEY CATHETER OUTER PACKAGING WAS DAMAGED, SO REPLACED WITH ANOTHER SET TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22026968 ↗
• MalfunctionMar 13, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY CATHETER HAD NATURAL REMOVAL EVENT OCCURRED AFTER DETENTION. IT WAS UNCLEAR FROM WHICH PART THE LEAK ORIGINATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21593705 ↗
• MalfunctionFeb 25, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING PRETEST THERE WAS RESISTANCE EVEN WHEN POURED WATER AND IT WAS NO LONGER POSSIBLE TO REMOVE WATER FROM THE FOLEY CATHETER. SYRINGE CONNECTION DID NOT FELL OUT EITHER NO, WATER WAS NOT DRAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21457910 ↗
• MalfunctionFeb 25, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING PRETEST THERE WAS RESISTANCE EVEN WHEN POURED WATER AND IT WAS NO LONGER POSSIBLE TO REMOVE WATER FROM THE FOLEY CATHETER. SYRINGE CONNECTION DID NOT FELL OUT EITHER. NO, WATER WAS NOT DRAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21457903 ↗
• MalfunctionDec 18, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE FOLEY CATHETER WHILE CATHETERIZING A PATIENT ON (B)(6) 2024, IT WAS FOUND THAT THE BOOSTER OF THE CATHETER WAS JAMMED AND THE CATHETER WAS IMMEDIATELY REPLACED WITH A NEW ONE, AND THE CATHETERIZATION WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20966384 ↗
• MalfunctionDec 12, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING THE CATHETERIZATION OF A PATIENT ON (B)(6) 2024, THE NURSE NOTICED THAT THE FOLEY CATHETER BALLOON WAS NOT EXPANDING PROPERLY, AND IMMEDIATELY REPLACED THE CATHETER WITH A NEW ONE, AND THE CATHETERIZATION WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20913210 ↗
• MalfunctionDec 11, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE NURSE UPON CHECKING THE FOLEY CATHETER FOUND THE BALLOON RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20901844 ↗
• MalfunctionNov 18, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED ON (B)(6) DUE TO BLADDER CANCER AND UNDERWENT SURGICAL TREATMENT ON (B)(6). AN 18FR FOLEY CATHETER WAS PLACED IN THE PELVIC AREA THROUGH THE URETHRA FOR DRAINAGE PURPOSES. THE AMOUNT OF FLUID INJECTED INTO THE CATHETER BALLOON DURING PLACEMENT WAS UNCLEAR. AFTER SURGERY, THE PATIENT WAS TRANSFERRED FROM THE OPERATING ROOM TO ROOM (B)(6) AT 19:40. DURING A FULL-BODY CLEANSING AT 06:00, WHILE PERFORMING PERINEAL IRRIGATION, THE CATHETER SLIPPED OUT OF THE URETHRA, REVEALING A NOTICEABLE RUPTURE IN THE BALLOON. REPLACED A NEW ONE TO SOLVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20706716 ↗
• MalfunctionOct 10, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DURING THE PRE-TEST OF FOLEY CATHETER THERE WAS A PINHOLE IN THE CUFF, SO IT WAS NOT POSSIBLE TO FILL WITH STERILE WATER. THERE WAS NO RESIDUAL IN THE BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20416756 ↗
• MalfunctionSep 26, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING PRETEST STERILE WATER COULD NOT BE INJECTED INTO THE FOLEY CATHETER AND COULD NOT INJECT ANY WATER AT ALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20310130 ↗
• MalfunctionSep 10, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PATIENT HAD A DIFFICULTY IN EMPTYING AND WITHDRAWING THE FOLEY CATHETER AND NEEDED TO USE THEM MORE OFTEN. REPRESENTATIVE ADVISED TO DISCUSS WITH DOCTOR AND ALSO WENT OVER ON PRICING FOR ORDERING ADDITIONAL AND WOULD ALSO DISCUSS DIFFERENT BRANDS IF NEEDED AFTER PATIENT DISCUSSES WITH THE DOCTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20179671 ↗
• MalfunctionAug 21, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITH A FOLEY CATHETER. ON (B)(6), THE PATIENT RETURNED TO THE WARD AND COMPLAINED OF URINE LEAKED FROM THE FOLEY CATHETER. AFTER EXAMINATION, IT WAS FOUND THAT THE BIFURCATION BETWEEN THE CATHETER AND THE DRAINAGE BAG INTERFACE WAS RUPTURED, CAUSING URINE LEAKED. THE CATHETER WAS IMMEDIATELY REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20009196 ↗
• MalfunctionAug 14, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT AFTER ENTERING THE ULTRASOUND ROOM, THE FOLEY CATHETER FELL OUT FOR SOME REASON. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 12AUG2024, IT WAS UNKNOWN WHETHER THERE WAS ANY HOLE IN THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19987685 ↗
• MalfunctionJun 26, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE WATER BALL INJECTION VALVE OF FOLEY CATHETER DRIPPED DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19613754 ↗
• MalfunctionApr 12, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT DAMAGE TO THE FOLEY CATHETER WAS FOUND ON THE FRONT END OF THE WATER POLO. DAMAGE WAS DISCOVERED BEFORE USE. PER FOLLOW UP RECEIVED VIA IBC ON 02APR2024, CONFIRMED THAT THERE WAS A DAMAGE IN THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19095646 ↗
• MalfunctionApr 3, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A LEAKAGE FROM THE FOLEY CATHETER, WATER INJECTED WAS 13CC AND THE WATER BALL WAS UNEVEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19031751 ↗
• MalfunctionNov 22, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON WAS RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18191575 ↗