Bardia® Foley Catheter Silicone Coated 123516ARecalls & reported problems

Summary

The FDA's MAUDE database contains 381 adverse event reports that list this exact device (DI 00801741095092), received between Apr 18, 2017 and Sep 30, 2026 — classified as 48 injuries, 333 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (50 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 381 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952604 ↗
• MalfunctionSep 29, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50940508 ↗
• MalfunctionSep 28, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926181 ↗
• MalfunctionSep 28, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926180 ↗
• MalfunctionSep 22, 2026Component Misassembled

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50858520 ↗
• MalfunctionSep 15, 2026Patient Device Interaction Problem

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50782013 ↗
• MalfunctionAug 24, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50420779 ↗
• MalfunctionAug 14, 2026Material Puncture/Hole; Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50255251 ↗
• MalfunctionAug 11, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50208854 ↗
• MalfunctionJun 17, 2026Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25537340 ↗
• MalfunctionMay 22, 2026Calcified

  IT WAS REPORTED THAT WHEN THIS DISPOSABLE STERILE FOLEY CATHETER WAS USED FOR PATIENTS WITH INDWELLING CATHETERS, DURING THE PERIOD OF INDWELLING USE, A LARGE AMOUNT OF FLOCCULENT SEDIMENT WAS DISCHARGED FROM THE CATHETER DRAINAGE END. THE FLOCCULENT MATERIAL GRADUALLY ACCUMULATES AND CLOGS THE CATHETER LUMEN, CAUSING URINE TO BE UNABLE TO DRAIN NORMALLY, RESULTING IN INTERRUPTED DRAINAGE AND URINE REFLUX. TO RESTORE NORMAL DRAINAGE, IT IS NECESSARY TO REMOVE THE BLOCKED CATHETER AND INSERT A NEW ONE FOR THE PATIENT. THIS PROCESS CAUSES SECONDARY HARM SUCH AS URETHRAL MUCOSAL INJURY, PAIN, AND INCREASED RISK OF INFECTION, WHILE ALSO INCREASING THE CLINICAL NURSING WORKLOAD AND PATIENT DISCOMFORT.

  Patient problems: Discomfort; Pain; Unspecified Tissue Injury

  MAUDE report 25260340 ↗
• MalfunctionMay 16, 2026Material Rupture

  IT WAS REPORTED THAT AFTER BEING LEFT IN PLACE FOR 13 DAYS, THE FOLEY CATHETER CAME OUT NATURALLY, AND UPON INSPECTION, IT WAS FOUND TO BE TORN. THE BALLOON WAS RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25196017 ↗
• MalfunctionApr 7, 2026Material Rupture

  IT WAS REPORTED THAT ON MARCH 17, 2026, AT 10:35, THE PATIENT UNDERWENT A LEFT FLEXIBLE URETEROSCOPY AND LITHOTRIPSY (FURSL) PROCEDURE WITH URETERAL STENT PLACEMENT UNDER GENERAL ANESTHESIA. UPON COMPLETION OF THE SURGERY, THE PATIENT RETURNED TO THE WARD AND RECEIVED INTRAVENOUS FLUID THERAPY, BEDSIDE CARDIAC MONITORING, AND OXYGEN SUPPORT AS PER PHYSICIAN'S ORDERS; THE INDWELLING URINARY CATHETER WAS SECURELY FIXED. ON MARCH 20, AT 12:43, THE PATIENT REPORTED THAT THEIR TROUSERS FELT DAMP; UPON ASSISTING THE PATIENT IN CHANGING THEIR TROUSERS, IT WAS DISCOVERED THAT THE URINARY CATHETER HAD DISLODGED. EXAMINATION REVEALED THAT THE CATHETER BALLOON HAD RUPTURED, ALTHOUGH THE BALLOON WALL ITSELF REMAINED INTACT. THE ATTENDING PHYSICIAN WAS IMMEDIATELY NOTIFIED; THE INDWELLING CATHETERIZATION WAS DISCONTINUED, AND THE PATIENT WAS INSTRUCTED TO INCREASE THEIR FLUID INTAKE. AT 13:15, THE PATIENT SUCCESSFULLY VOIDED SPONTANEOUSLY, AND THE ADVERSE EVENT WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24810967 ↗
• MalfunctionMar 25, 2026Material Puncture/Hole

  IT WAS REPORTED THAT DURING USE, THE FOLEY CATHETER BALLOON LEAKAGE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24690661 ↗
• MalfunctionMar 11, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT 30 FOLEY CATHETER SAMPLES WERE TESTED BEFORE USE, ONE OF WHICH GREW SULFUR-ETHANOL BACTERIA. RE-TESTING CONFIRMED PERSISTENT BACTERIAL GROWTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24573231 ↗
• MalfunctionFeb 23, 2026Material Twisted/Bent

  IT WAS REPORTED THAT DURING USE, THE FOLEY CATHETER SURFACE APPEARED TO BE DEFORMED AND IRREGULAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24422028 ↗
• MalfunctionJan 27, 2026Material Puncture/Hole; Material Rupture

  IT WAS REPORTED THAT WATER LEAKED FROM THE FOLEY CATHETER BALLOON AND SLIPS OFF 1 TO 2 HOURS AFTER USE. PATIENT EXPOSURE TO BLOOD/BODILY FLUID URINE.

  Patient problems: Exposure to Body Fluids

  MAUDE report 24195526 ↗
• MalfunctionJan 13, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS LEAKING. NO INFORMATION PROVIDED IF THEY SEEK MEDICAL INTERVENTION. THEY HAVE ALREADY CREDITED OR REPLACED PRODUCT FOR THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24060902 ↗
• MalfunctionDec 15, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT ABOUT MORE THAN A MONTH AGO, THE PATIENT SUDDENLY DEVELOPED RIGHT-SIDED LUMBAR AND ABDOMINAL PAIN WITHOUT ANY OBVIOUS CAUSE. THE PAIN RECURRED REPEATEDLY, WITH PAROXYSMAL INTENSIFICATION. WHEN THE PAIN WAS SEVERE, IT WAS ACCOMPANIED BY NAUSEA AND AN URGE TO VOMIT, BUT NO GROSS HEMATURIA WAS OBSERVED. OVER THE PAST MONTH, THERE WAS NO SIGNIFICANT IMPROVEMENT, SO THE PATIENT WAS ADMITTED TO OUR HOSPITAL FOR FURTHER DIAGNOSIS AND TREATMENT. AFTER ADMISSION, RELEVANT EXAMINATIONS WERE COMPLETED. ON (B)(6) 2025, AT 14:00, THE PATIENT UNDERWENT RIGHT FLEXIBLE URETEROSCOPY AND LASER LITHOTRIPSY (FURSL) SURGERY AND URETERAL STENT PLACEMENT UNDER GENERAL ANESTHESIA. AFTER SURGERY, A URINARY FOLEY CATHETER WAS INSERTED AND RETAINED. AT 20:55, DURING A WARD ROUND, IT WAS DISCOVERED THAT THE PATIENT'S CATHETER HAD FALLEN OUT. UPON CHECKING THE BALLOON, IT WAS FOUND TO BE RUPTURED, THOUGH THE STENT WAS INTACT, WHICH DELAYED CATHETERIZATION. THE ON-DUTY DOCTOR WAS IMMEDIATELY INFORMED, AND MEDICAL ORDERS WERE GIVEN TO DISCONTINUE THE INDWELLING CATHETER, INCREASE WATER INTAKE, AND MONITOR THE PATIENT'S URINATION. AT 21:10, THE PATIENT DID NOT REPORT ANY DISCOMFORT AND WAS AB

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23811717 ↗
• MalfunctionDec 12, 2025Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23796978 ↗
• MalfunctionDec 12, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT, THE WATER IN THE FOLEY CATHETER BALLOON COULD NOT BE FILLED WITH WATER NORMALLY AND APPEARED TO HAD RUPTURED. NO MEDICAL INTERVENTION WAS REPORTED. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 07JAN2026, STATED THAT NO PATIENT HARM WAS REPORTED.

  Patient problems: Exposure to Body Fluids

  MAUDE report 23796667 ↗
• MalfunctionDec 10, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY ON (B)(6) WITH AN INDWELLING URINARY CATHETER PLACED. THE FOLEY CATHETER WAS WELL SECURED AND DRAINED PALE-YELLOW URINE. TODAY, THE PATIENT REPORTED DIFFICULTY URINATING. UPON EXAMINATION, THE CATHETER HAD BECOME DISLODGED. THE URINARY CATHETER WAS REINSERTED AND SECURELY FIXED, AND PALE-YELLOW URINE WAS DRAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23769012 ↗
• InjuryNov 7, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT ON (B)(6) 2025, AT 5:20 PM, AFTER A BLADDER STONE REMOVAL PROCEDURE, THE FOLEY CATHETER WAS PLACED AND THE PATIENT RETURNED TO THE ROOM. AT 8:20 PM, THE PATIENT BECAME SUSPICIOUS THAT THE CATHETER WAS NOT DRAINING, SO ASKED THE UROLOGIST TO PERFORM A BLADDER IRRIGATION BUT WAS UNABLE TO DO SO. UPON REMOVING THE FOLEY CATHETER, THE PATIENT DISCOVERED THAT THE EYE WAS NOT OPEN. MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23497748 ↗
• MalfunctionNov 4, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE MEDICAL STAFF DISCOVERED DURING USE THAT THE BALLOON OF A SINGLE-USE STERILE FOLEY CATHETER RUPTURED. PATIENT EXPERIENCED URETERAL PAIN.

  Patient problems: Pain

  MAUDE report 23467461 ↗
• MalfunctionNov 3, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT THERE WERE 10 IN A BOX, BUT ONLY 8 FOLEY CATHETER WERE INCLUDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23452606 ↗