Bardex® I.C. Foley Catheter 0165SI20Recalls & reported problems

Summary

The FDA's MAUDE database contains 81 adverse event reports that list this exact device (DI 00801741016776), received between Mar 29, 2017 and Jan 13, 2026 — classified as 2 injuries, 79 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (14 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 81 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2026Inaccurate Flow Rate

  IT WAS REPORTED THE PATIENT STATED HE RECEIVED A DEFECTIVE FOLEY CATHETER. HE DID NOT HAVE THE LOT NOR SERIAL NUMBER. IT IS UNCLEAR IF TROUBLESHOOTING WAS PERFORMED. NO MEDICAL INTERVENTION OR PATIENT IMPACT REPORTED. NO ADDITIONAL INFORMATION PROVIDED. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 05DEC2025, PATIENT STATED THEY WERE UNABLE TO GET URINE TO FLOW THROUGH THE CATHETER. HE WAITED A FEW MINUTES BEFORE TRYING ANOTHER CATHETER. UPON TRYING A NEW CATHETER, URINE BEGAN TO FLOW. HE STATED HE DID NOT HAVE TIME TO TRY FIGURING OUT WHAT EXACTLY WAS WRONG WITH IT AND DISCARDED THE PACKAGING WITH THE LOT NUMBER. A REPLACEMENT CATHETER HAS ALREADY BEEN SHIPPED. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO MEDICAL INTERVENTION OR PATIENT IMPACT REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24063197 ↗
• MalfunctionOct 30, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT WHEN A PATIENT WAS PERFORMING A PRE-TEST TO INSERT A FOLEY CATHETER FOR URINARY CATHETERIZATION IN NORTH WARD 3, THE STERILE WATER DID NOT RETURN. WHEN THE PATIENT TRIED TO TWIST THE SYRINGE TO REMOVE IT, IT WAS STUCK FIRMLY AND COULD NOT BE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23429026 ↗
• MalfunctionOct 10, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE FOLEY CATHETER CONNECTOR FOR INJECTING STERILE WATER HAD COME OFF WHEN THE PRODUCT WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23266506 ↗
• MalfunctionAug 27, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT, AFTER OPENING THE PRODUCT, THERE WAS SOMETHING RED AND STAIN-LIKE ON THE TIP OF THE FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22903188 ↗
• MalfunctionJul 29, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS PLACED ON (B)(6) 2025 AND IT WAS CONFIRMED THAT THE URINE WAS NOT BEING DRAINED ON (B)(6) 2025. IT WAS RETRIEVED AS IT WAS NOTED THAT THE LUMEN WAS OBSTRUCTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22644035 ↗
• MalfunctionJul 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING USE THAT WAS A LEAK FROM A FOLEY CATHETER. IT OCCURRED IN A PATIENT AT HOME, BUT IT WAS UNCLEAR WHERE THE LEAK CAME FROM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22554327 ↗
• MalfunctionMay 22, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THEY WERE FACING RECURRING PROBLEM WITH SALINE WITHDRAWAL FROM BALLOON OF THE FOLEY CATHETER. NO ADVERSE EVENTS HAVE BEEN REPORTED. ONCE SALINE IS PLACED IN THE BALLOON, IT CANNOT BE WITHDRAWN. SAMPLES HAVE BEEN DISCARDED DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22069822 ↗
• MalfunctionApr 10, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT A FOLEY CATHETER WAS PLACED IN THE OPERATING ROOM FOR URINARY CATHETERIZATION, AND WHILE THE PATIENT WAS BEING MANAGED IN THE WARD, THE FOLEY CATHETER WAS REMOVED NATURALLY. AS A PRECAUTION, STERILE WATER WAS INJECTED, BUT NO DAMAGE TO THE BALLOON WAS CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21814289 ↗
• MalfunctionApr 3, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THE FOLEY CATHETER WAS IMPLANTED IN AN OUTPATIENT AND IT WAS NATURALLY REMOVED AFTER ABOUT 2 OR 3 DAYS. THE BALLOON PORTION OF THE CATHETER THAT WAS REMOVED HAD CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21761319 ↗
• MalfunctionMar 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT STERILE WATER LEAK FROM THE FOLEY CATHETER WAS DISCOVERED DURING TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21632618 ↗
• MalfunctionMar 5, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT DISCOVERED A LEAK OF STERILIZED WATER FROM THE FOLEY CATHETER DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21525800 ↗
• MalfunctionJan 13, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT CUSTOMER ADVISED TWICE WITHIN THE LAST THREE MONTHS THE FOLEY CATHETER BALLOON HAD GOTTEN STUCK DURING REMOVAL. THEY WERE UNABLE TO DRAIN THE FLUID FROM THE CATHETER. CUSTOMER ALSO ADVISED THEY NOTICED THE STERILE WATER DROPPED WITHIN A DAY OR SO- OFTEN THEY HAD TO ADD WATER SO THAT IT REMAINED IN PLACE. CUSTOMER CONFIRMED DURING INSERTION THEY INFLATED FOLEY CATHETER WITH ENTIRE AMOUNT OF STERILE WATER IN THE SYRINGE. REPRESENTATIVE ADVISED TO DEFLATE THE CATHETER BALLOON, GENTLY INSERT A LUER SLIP TIP SYRINGE INTO THE CATHETER VALVE WITHOUT USING EXCESSIVE FORCE. LET THE BALLOON'S PRESSURE PUSH THE PLUNGER BACK, FILLING THE SYRINGE WITH WATER. IF DEFLATION WAS SLOW OR DID NOT OCCUR, RESEAT THE SYRINGE GENTLY AND USE LIGHT ASPIRATION IF NECESSARY. AVOID VIGOROUS ASPIRATION TO PREVENT COLLAPSING THE INFLATION LUMEN. IF ALLOWED BY HOSPITAL PROTOCOL, CUSTOMER MIGHT SEVER THE VALVE ARM. IF THESE STEPS FAILED, SEEK ASSISTANCE FROM A TRAINED PROFESSIONAL. ENSURE ALL BALLOON FRAGMENTS WERE REMOVED IF THE BALLOON RUPTURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21137985 ↗
• MalfunctionJan 8, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT CUSTOMER ADVISED TWICE WITHIN THE LAST THREE MONTHS THE FOLEY CATHETER BALLOON HAD GOTTEN STUCK DURING REMOVAL. THEY WERE UNABLE TO DRAIN THE FLUID FROM THE CATHETER. CUSTOMER ALSO ADVISED THEY NOTICED THE STERILE WATER DROPPED WITHIN A DAY OR SO- OFTEN THEY HAD TO ADD WATER SO THAT IT REMAINED IN PLACE. CUSTOMER CONFIRMED DURING INSERTION THEY INFLATED FOLEY CATHETER WITH ENTIRE AMOUNT OF STERILE WATER IN THE SYRINGE. REPRESENTATIVE ADVISED TO DEFLATE THE CATHETER BALLOON, GENTLY INSERT A LUER SLIP TIP SYRINGE INTO THE CATHETER VALVE WITHOUT USING EXCESSIVE FORCE. LET THE BALLOON'S PRESSURE PUSH THE PLUNGER BACK, FILLING THE SYRINGE WITH WATER. IF DEFLATION WAS SLOW OR DID NOT OCCUR, RESEAT THE SYRINGE GENTLY AND USE LIGHT ASPIRATION IF NECESSARY. AVOID VIGOROUS ASPIRATION TO PREVENT COLLAPSING THE INFLATION LUMEN. IF ALLOWED BY HOSPITAL PROTOCOL, CUSTOMER MIGHT SEVER THE VALVE ARM. IF THESE STEPS FAILED, SEEK ASSISTANCE FROM A TRAINED PROFESSIONAL. ENSURE ALL BALLOON FRAGMENTS WERE REMOVED IF THE BALLOON RUPTURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21101830 ↗
• InjuryNov 18, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT LAST FOLEY CATHETER PATIENT RECEIVED WAS LATEX AND IT CAUSED IF ALL SORTS OF PROBLEMS AND THEY HAD TO GO IT TAKEN OUT AND REPLACED. PER CUSTOMER FOLLOW UP RECEIVED ON 29OCT2024, IT WAS REPORTED THAT THE CATHETERS THEY ORDERED CONTAINED LATEX AND CAUSED THEM TO HAVE AN ALLERGIC REACTION. CUSTOMER VISITED THE UROLOGIST AND RECEIVED MEDICINE TO TREAT THE PAIN CAUSED BY THE REACTION. UROLOGIST PRESCRIBED CUSTOMER A DIFFERENT TYPE OF CATHETER AND CUSTOMER STATED THAT THE ONES WITH THE WATER PACKETS WORK BETTER FOR THEM. NO OTHER ISSUES WERE REPORTED.

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 20705268 ↗
• MalfunctionOct 17, 2024Inflation Problem; Material Puncture/Hole; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE BALLOON DID NOT INFLATE AFTER PLACEMENT OF FOLEY CATHETER, AND WHEN TRIED AGAIN OUTSIDE, IT DID NOT INFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20472540 ↗
• MalfunctionSep 16, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS SPONTANEOUSLY EXTRACTED THE NEXT DAY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20224923 ↗
• MalfunctionSep 12, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE FIRST DAY AFTER PLACEMENT, THE FOLEY CATHETER WAS SPONTANEOUSLY REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20200018 ↗
• MalfunctionSep 12, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS NATURALLY REMOVED. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 01SEP2024, STATED THAT THERE WAS A PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20199997 ↗
• MalfunctionSep 3, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THEY CHANGED BALLOON ON JULY 31ST. ON AUGUST 11TH, THE 13TH DAY, WHILE CHANGING A DIAPER, THEY DISCOVERED THAT THE FOLEY CATHETER BALLOON PART WAS BROKEN SO, THE FOLEY CATHETER HAD NATURALLY REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20128711 ↗
• MalfunctionSep 3, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT IMMEDIATELY AFTER INSERTION, THE STERILE WATER DID NOT ENTER INTO THE FOLEY CATHETER AND THERE WAS DAMAGE NEAR THE CUFF OR CATHETER SHAFT. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 29AUG2024, STATED THAT THE DAMAGE NEAR THE CUFF OR CATHETER SHAFT WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20128392 ↗
• MalfunctionAug 2, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE CATHETER WAS REMOVED AS IT WAS BECAUSE IT COULD NOT BE DRAINED AT THE TIME OF CATHETER REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19892938 ↗
• MalfunctionJul 29, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THERE WAS AN INFLATION LUMEN PINHOLE LEAK IN THE FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19849738 ↗
• MalfunctionMay 22, 2024Material Puncture/Hole; Failure to Infuse; Material Puncture/Hole; Failure to Infuse

  IT WAS REPORTED THAT IN DETENTION FOLEY CATHETER WAS NATURALLY REMOVED AFTER BEING KEPT IN CUSTODY FOR 3 OR 4 DAYS AND THERE WAS PROBABLY LEAK IN THE BALLOON PART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19371882 ↗
• MalfunctionApr 18, 2024Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT WHEN REMOVING THE FIXED WATER DURING REMOVAL OF FOLEY CATHETER, IT WAS MORE DIFFICULT TO REMOVE THAN USUAL AND IT TOOK ABOUT 15 MINUTES TO REMOVE THE WATER. THEY DID MANUAL SUCTION TO REMOVE THE WATER BY USING OTHER COMPANY'S SYRINGE. THE LOT NUMBER WAS UNKNOWN. PER ADDITIONAL INFORMATION VIA EMAIL FROM IBC ON 12MAR2024, IT WAS STATED THAT THERE WAS NO HARM TO THE PATIENT. PER ADDITIONAL INFORMATION ON 29MAR2024, IT WAS STATED THERE WAS BLOCKAGE ON (B)(6) 2024 , (B)(6) 2024 AND WAS TEMPORARILY REPLACED. DUE TO HIGH RISK OF OBSTRUCTION, BLADDER IRRIGATION WAS INCREASED FROM 3 TIMES PER WEEK TO 4 TIMES PER WEEK AND THE PROGRESS WAS MONITORED. ON (B)(6) 16:00, THERE WAS ABOUT 500G OF URINE LEAKING IN THE DIAPER. THERE WAS ALSO SLIGHT AMOUNT OF URINE LEAKING INTO THE CATHETER. ALTHOUGH THE BLADDER WAS WASHED, THERE WAS STRONG RESISTANCE AND SALINE COULD NOT BE INJECTED. AT 4:30PM ASKED THE DOCTOR ON DUTY TO PERFORM CATHETER EXCHANGE. WHEN THEY REPLACED IT, THERE WAS A LOT OF RESISTANCE WHEN PULLING THE FIXED WATER FROM THE CATHETER AND THEY COULD NOT PULL IT SMOOTHLY. ABOUT 8ML OF FIXED WATER WAS COLLECTED WHILE MILKING FOR ABOUT 15 MINUTES AND THE CATHETER WAS REM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19133233 ↗
• MalfunctionApr 17, 2024Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS SPONTANEOUS REMOVAL OCCURRED IMMEDIATELY AFTER PLACEMENT. ALTHOUGH FIXED WATER WAS POURED INTO THE CATHETER AFTER IT WAS REMOVED, THE BALLOON DEFLATED IMMEDIATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19124103 ↗