Bardia 123516CERecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00801741171680), received between Feb 6, 2025 and Jun 1, 2026 — classified as 2 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Disconnection” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2026Fluid/Blood Leak; Material Split, Cut or Torn

  It was reported that thirty minutes after foley catheter insertion, leakage was observed. Upon inspection, it was found that the catheter bifurcation was damaged.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25352859 ↗
• InjuryMar 20, 2026Material Rupture

  IT WAS REPORTED THAT THE PATIENT ARRIVED AT (B)(6) CLINIC HAVING HAD SUPRAPUBIC CATHETER REMOVED BY HOMECARE. PATIENT REQUIRED RE-INSERTION OF SAME. WHILE PATIENT WAS BEING SCOPED THE PHYSICIAN NOTED A PIECE OF THE BALLOON STILL IN THE BLADDER AND WAS ABLE TO SUCCESSFULLY REMOVE SAME. CATHETER WAS A 16 FRENCH BARD LATEX FOLEY THAT HAD BEEN INSERTED ON (B)(6) 2026. BALLOON HAD BEEN PROPERLY INFLATED WITH THE CORRECT AMOUNT OF FLUID.

  Patient problems: Foreign Body In Patient

  MAUDE report 24649575 ↗
• MalfunctionDec 12, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE FOLEY CATHETER INFLATION VALVE GOT DETACHED AND FALLEN OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23796960 ↗
• MalfunctionDec 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING USE THE FOLEY CATHETER BALLOON RUPTURED, AND CATHETER SLIPPAGE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23763312 ↗
• MalfunctionDec 5, 2025Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE FOLEY CATHETER IRRIGATION LUMEN WAS UNUSABLE POSSIBLY DUE TO A BLOCKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23727823 ↗
• MalfunctionDec 4, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE CUSTOMER WAS ONLY ABLE TO REMOVE 5CC OF SALINE FROM OLD FOLEY CATHETER BALLOON (TYPICALLY REMOVE 10). CUSTOMER ATTEMPTED TO REMOVE FOLEY CATHETER FROM URETHRA HOWEVER RESISTANCE MET. ANOTHER REGISTERED NURSE WHO WAS PRESENT ON THE HOME VISIT ALSO ATTEMPTED TO REMOVE SALINE FROM CATHETER BALLOON, HOWEVER UNABLE TO EXTRACT ANY MORE. CUSTOMER APPLIED GENTLE FORCE AND REMOVED CATHETER, BALLOON SLIGHTLY INFLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23723067 ↗
• MalfunctionDec 4, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING USE THE FOLEY CATHETER BALLOON RUPTURED, AND THE FOLEY CATHETER SLIPPAGE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23717508 ↗
• MalfunctionDec 4, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING USE THE FOLEY CATHETER BALLOON RUPTURED, AND THE FOLEY CATHETER SLIPPAGE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23717507 ↗
• MalfunctionDec 4, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING USE THE FOLEY CATHETER BALLOON RUPTURED, AND CATHETER SLIPPAGE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23717294 ↗
• MalfunctionOct 15, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON WAS RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23301741 ↗
• MalfunctionSep 30, 2025Material Fragmentation; Material Split, Cut or Torn; Material Fragmentation; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE FOLEY BALLOON CATHETER WAS ACCIDENTALLY CUT OR TORN, IMMEDIATE ASSESSMENT WAS PERFORMED, AND THE PATIENT WAS CLOSELY MONITORED, THE BROKEN CATHETER WAS REPLACED WITH A NEW STERILE CATHETER, AND THE PATIENT WAS OBSERVED IF ANY SIGNS OF DISCOMFORT, BLEEDING OR URINARY RETENTION WAS THERE. BUT THE PATIENT WAS EXPOSED TO URINE. ATTENDING PHYSICIAN WAS INFORMED IMMEDIATELY. PATIENT REMAINED STABLE AFTER REINSERTION OF CATHETER, NO IMMEDIATE ADVERSE EFFECTS WERE NOTED. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Exposure to Body Fluids

  MAUDE report 23179863 ↗
• MalfunctionApr 7, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT BEFORE USE, THE WATER INJECTION JOINT OF THE FOLEY CATHETER WAS DISCONNECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21785110 ↗
• MalfunctionMar 26, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT AFTER THE FOLEY CATHETER WAS PLACED, IT WAS CONFIRMED THAT THE POSITION WAS CORRECT, BUT URINE COULD NOT BE DRAINED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21697896 ↗
• MalfunctionFeb 26, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT DURING THE FOLEY CATHETER PLACEMENT, THE INJECTION VALVE SUDDENLY SEPARATED WHEN THE WATER BALLOON WAS SCHEDULED TO BE INJECTED, AND THE OTHER TUBE WAS REPLACED, AND THE WATER BALLOON INJECTION VALVE END AGAIN SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21469359 ↗
• InjuryFeb 19, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON CANNOT BE WITHDRAWN AND NEEDS TO BE REPLACED. THE UROLOGY DOCTOR WAS CONSULTED, AND PATIENT WAS SENT TO THE OPERATING ROOM TO REMOVE THE FOLEY CATHETER. IT ALSO CAME IN EXPOSURE TO URINE.

  Patient problems: Exposure to Body Fluids

  MAUDE report 21410779 ↗
• MalfunctionFeb 6, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT AFTER THE NURSE PLACED THE URINARY FOLEY CATHETER, THE WATER BALLOON WAS SCHEDULED TO BE INJECTED AND THE NEEDLE WAS EMPTY, AFTER ENGAGED WITH THE INJECTION VALVE END, THE INJECTION VALVE DROPPED SUDDENLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21321712 ↗
• MalfunctionFeb 6, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT DURING THE PLACEMENT OF THE URINARY FOLEY CATHETER, THE NURSE SCHEDULED TO INJECT THE WATER BALLOON, AND AFTER THE EMPTY NEEDLE WAS ENGAGED WITH THE INJECTION VALVE END, THE INJECTION WATER BALLOON WAS HALFWAY THROUGH, AND THE INJECTION VALVE SUDDENLY SEPARATED FROM THE URETHRAL CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21321708 ↗