Bardex® Lubricath® Pediatric Foley Catheter 0165PL08Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00801741017667), received between Jul 7, 2017 and Sep 10, 2026 — classified as 3 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Inaccurate Flow Rate” (4 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Material Rupture

  It was reported that because a 14Fr Foley catheter balloon couldn't be inserted into the patient, used a pediatric 8Fr balloon and injected 10cc of sterile water, but the balloon ended up bursting later.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50717389 ↗
• MalfunctionMar 10, 2026Incorrect Measurement

  IT WAS REPORTED THAT ON (B)(6) 2026 THE 8FR BARD FOLEY CATHETER WAS INSERTED IN THE OPERATING THEATRE. ON (B)(6) 2026 LOW URINE OUTPUT WAS NOTED. THE CATHETER WAS FLUSHED BY DR. HARI OF PEDIATRIC INTENSIVE CARE UNIT. AFTER DISCUSSION WITH THE SURGICAL TEAM, THE CATHETER WAS REMOVED DUE TO PERSISTENT POOR DRAINAGE. ON (B)(6) 2026 THE SECOND 8FR BARD FOLEY CATHETER WAS INSERTED. LOW URINE OUTPUT RECURRED. FLUSHING YIELDED APPROXIMATELY 10 ML OF URINE, AFTER WHICH THE CATHETER WAS REMOVED ON (B)(6) 2026. ON (B)(6) 2026 A THIRD 8FR BARD FOLEY CATHETER WAS INSERTED. URINE OUTPUT WAS SEEN ONLY AFTER FLUSHING, INDICATING ONGOING DRAINAGE DIFFICULTY. REPEATED LOW URINE OUTPUT OCCURRED DESPITE THREE CATHETER INSERTIONS USING THE SAME SIZE 8FR AND SAME BRAND BARD. THE URINE OUTPUT IMPROVED ONLY AFTER CATHETER FLUSHING, SUGGESTING A MECHANICAL DRAINAGE PROBLEM RATHER THAN TRUE OLIGURIA. BEDSIDE ULTRASOUND DEMONSTRATED A DISTENDED BLADDER DESPITE MINIMAL CATHETER OUTPUT, FURTHER SUPPORTING IMPAIRED CATHETER DRAINAGE. IT WAS REPORTED THAT THE PATIENT WAS A PEDIATRIC AT THE AGE OF 1YEAR 10MONTHS AND THEY USED 8FR BARDIA FOLEY CATHETER. HCP FEELS THEY RECEIVED THE STOCK THE LATEX QUALITY AND THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24563152 ↗
• MalfunctionFeb 27, 2026Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2026 THE 8FR BARD FOLEY CATHETER WAS INSERTED IN THE OPERATING THEATRE. ON (B)(6) 2026 LOW URINE OUTPUT WAS NOTED. THE CATHETER WAS FLUSHED BY THE DOCTOR OF PEDIATRIC INTENSIVE CARE UNIT. AFTER DISCUSSION WITH THE SURGICAL TEAM, THE CATHETER WAS REMOVED DUE TO PERSISTENT POOR DRAINAGE. ON (B)(6) 2026 THE SECOND 8FR BARD FOLEY CATHETER WAS INSERTED. LOW URINE OUTPUT RECURRED. FLUSHING YIELDED APPROXIMATELY 10ML OF URINE, AFTER WHICH THE CATHETER WAS REMOVED ON (B)(6) 2026. ON (B)(6) 2026 A THIRD 8FR BARD FOLEY CATHETER WAS INSERTED. URINE OUTPUT WAS SEEN ONLY AFTER FLUSHING, INDICATING ONGOING DRAINAGE DIFFICULTY. REPEATED LOW URINE OUTPUT OCCURRED DESPITE THREE CATHETER INSERTIONS USING THE SAME SIZE 8FR AND SAME BRAND BARD. THE URINE OUTPUT IMPROVED ONLY AFTER CATHETER FLUSHING, SUGGESTING A MECHANICAL DRAINAGE PROBLEM RATHER THAN TRUE OLIGURIA. BEDSIDE ULTRASOUND DEMONSTRATED A DISTENDED BLADDER DESPITE MINIMAL CATHETER OUTPUT, FURTHER SUPPORTING IMPAIRED CATHETER DRAINAGE. IT WAS REPORTED THAT THE PATIENT WAS A PEDIATRIC AT THE AGE OF 1YEAR 10MONTHS AND THEY USED 8FR BARDIA FOLEY CATHETER. HCP FEELS THEY RECEIVED THE STOCK THE LATEX QUALITY AND THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24475115 ↗
• InjuryFeb 25, 2026Inaccurate Flow Rate

  IT WAS REPORTED THAT ON (B)(6) 2026 THE 8FR BARD FOLEY CATHETER WAS INSERTED IN THE OPERATING THEATRE. ON (B)(6) 2026 LOW URINE OUTPUT WAS NOTED. THE CATHETER WAS FLUSHED BY THE DR OF PEDIATRIC INTENSIVE CARE UNIT. AFTER DISCUSSION WITH THE SURGICAL TEAM, THE CATHETER WAS REMOVED DUE TO PERSISTENT POOR DRAINAGE. ON (B)(6) 2026 THE SECOND 8FR BARD FOLEY CATHETER WAS INSERTED. LOW URINE OUTPUT RECURRED. FLUSHING YIELDED APPROXIMATELY 10ML OF URINE, AFTER WHICH THE CATHETER WAS REMOVED ON (B)(6) 26. ON (B)(6) 2026 A THIRD 8FR BARD FOLEY CATHETER WAS INSERTED. URINE OUTPUT WAS SEEN ONLY AFTER FLUSHING, INDICATING ONGOING DRAINAGE DIFFICULTY. REPEATED LOW URINE OUTPUT OCCURRED DESPITE THREE CATHETER INSERTIONS USING THE SAME SIZE 8FR AND SAME BRAND BARD. THE URINE OUTPUT IMPROVED ONLY AFTER CATHETER FLUSHING, SUGGESTING A MECHANICAL DRAINAGE PROBLEM RATHER THAN TRUE OLIGURIA. BEDSIDE ULTRASOUND DEMONSTRATED A DISTENDED BLADDER DESPITE MINIMAL CATHETER OUTPUT, FURTHER SUPPORTING IMPAIRED CATHETER DRAINAGE. IT WAS REPORTED THAT THE PATIENT WAS A PEDIATRIC AT THE AGE OF 1YEAR 10MONTHS AND THEY USED 8FR BARDIA FOLEY CATHETER. HCP FEELS THEY RECEIVED THE STOCK THE LATEX QUALITY AND THE LENGT

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

  MAUDE report 24445376 ↗
• InjuryFeb 25, 2026Inaccurate Flow Rate

  It was reported that on (b)(6) 2026 the 8Fr Bard Foley catheter was inserted in the operating theatre. On (b)(6) 2026 low urine output was noted. The catheter was flushed by the dr of pediatric intensive care unit. After discussion with the surgical team, the catheter was removed due to persistent poor drainage. On (b)(6) 2026 the second 8Fr Bard Foley catheter was inserted. Low urine output recurred. Flushing yielded approximately 10mL of urine, after which the catheter was removed on (b)(6) 2026. On (b)(6) 2026 a third 8Fr Bard Foley catheter was inserted. Urine output was seen only after flushing, indicating ongoing drainage difficulty. Repeated low urine output occurred despite three catheter insertions using the same size 8Fr and same brand Bard. The urine output improved only after catheter flushing, suggesting a mechanical drainage problem rather than true oliguria. Bedside ultrasound demonstrated a distended bladder despite minimal catheter output, further supporting impaired catheter drainage. It was reported that the patient was a Pediatric at the age of 1year 10months and they used 8fr Bardia Foley catheter. Hcp feels they received the stock the latex quality and the len

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

  MAUDE report 24442293 ↗
• InjuryJan 16, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT PATIENT FEELING DISCOMFORT FROM FOLEY CATHETER SITE AFTER INSERTION. FOLLOWING PRODUCT INSTRUCTIONS FOR BALLOON CC FILL, BALLOON FILLED TO SPECIFIC INSTRUCTIONS. PATIENT CONTINUED TO EXPERIENCE PAIN, AND A NOTABLE AUDIBLE POP SOUND OCCURRED WITH FAMILY AND NURSE HEARD THIS SOUND. PATIENT PAIN SUBSIDED. PATIENT FOLEY WAS THEN REMOVED AND NOTED THE BALLOON OF FOLEY WAS BROKEN. PATIENT UNDERWENT INVESTIGATION FOR ANY REMNANTS IN BLADDER. AS PATIENT HAD TO UNDERGO ADDITIONAL PROCEDURE TO REMOVE REMNANTS OF THE FOLEY BALLOON RUPTURE WITHIN THE PEDIATRIC PATIENT'S BLADDER. PATIENT ENDURED PAIN PRIOR AND DURING RUPTURE. PER ADDITIONAL INFORMATION RECEIVED ON 22JAN2025, IT WAS REPORTED THAT THE FOLEY CATHETER CAUSING DISCOMFORT AND PAIN TO PATIENT, HAVING TO UNDERGO INVESTIGATION OR REMOVAL OF ANY FURTHER MATERIAL CAUSED BY FOLEY BALLOON RUPTURE. PATIENT COMPLAINING ABOUT CATHETER HURTING CAUSING PAIN. CATHETER PLACED IN IVR, AND PATIENT CAME UP TO PEDIATRICS. WHEN TRYING TO MOVE PATIENT FOR REPOSITIONING AND TO INVESTIGATE CATHETER, AUDIBLE POP SOUND HEARD BY NURSE, EDUCATOR, FAMILY AND PATIENT. URINE EMPTIED WITH NO BLOOD OR RED TINGE NOTED. CATHETER CAME OUT AND NOT

  Patient problems: Discomfort; Foreign Body In Patient; Pain

  MAUDE report 21168239 ↗
• MalfunctionNov 27, 2024Wrong Label; Wrong Label

  IT WAS REPORTED THAT THE FOLEY CATHETER RIPPED BALLOON HAD WRONG SIZE INSIDE THE PACKAGE AND THE PRODUCT INSIDE WAS 8FR/5ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20796804 ↗
• MalfunctionSep 12, 2024Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE PATIENT HAD A FOLEY PLACED FOR CLOSE URINE OUTPUT MONITORING RELATED TO THE PATIENT HAVING SUSTAINED THIRD DEGREE BURNS AND WAS RECEIVING 1.5X MAINTENANCE FLUIDS. THE PATIENT WAS NOTED TO HAVE DIMINISHED URINE OUTPUT (LESS THAN 1ML/KG), THE PICU AND BURN TEAM DOCTORS DETERMINED TO INCREASE THEIR IV FLUID RATE AND LET THEM DRINK FORMULA. THEIR URINE OUTPUT CONTINUED TO REMAIN LOW AND AN NGT WAS PLACED AND SO THEY RECEIVED FORMULA VIA THEIR NGT IN ADDITION TO DRINKING BY MOUTH. THEIR URINE OUTPUT CONTINUED TO BE LOW DESPITE INTERVENTIONS. THE ORIENTING NURSE AND THE OTHER NURSE PERFORMED A BLADDER SCAN ON THE PATIENT WHICH SHOWED GREATER THAN 100ML IN THE BLADDER. THEY DISCUSSED WITH ANOTHER NURSE ON THE FLOOR HOW BEST TO TROUBLESHOOT THE FOLEY CATHETER, THEY FLUSHED IT BUT WERE NOT ABLE TO GET URINE BACK FROM IT. IT WAS ODD THAT IT SHOULD NEED TO BE FLUSHED AT ALL SINCE THE URINE WAS CLEAR (AS OPPOSED TO WHEN IT HAD SEDIMENT IN IT AND GOT CLOGGED MORE OFTEN). THEY THEN DEFLATED THE BALLOON, CLEANED THE PATIENT AND ADVANCED THE FOLEY FURTHER, WHICH ALSO DID NOT RESULT IN FREE FLOWING URINE. AT ANOTHER NURSES ENCOURAGEMENT THEY CHANGED THE FOLEY TO A DIFFERENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20199751 ↗
• MalfunctionSep 12, 2024Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE PATIENT HAD A FOLEY PLACED FOR CLOSE URINE OUTPUT MONITORING RELATED TO THE PATIENT HAVING SUSTAINED THIRD DEGREE BURNS AND WAS RECEIVING 1.5X MAINTENANCE FLUIDS. THE PATIENT WAS NOTED TO HAVE DIMINISHED URINE OUTPUT (LESS THAN 1ML/KG), THE PICU AND BURN TEAM DOCTORS DETERMINED TO INCREASE THEIR IV FLUID RATE AND LET THEM DRINK FORMULA. THEIR URINE OUTPUT CONTINUED TO REMAIN LOW AND AN NGT WAS PLACED AND SO THEY RECEIVED FORMULA VIA THEIR NGT IN ADDITION TO DRINKING BY MOUTH. THEIR URINE OUTPUT CONTINUED TO BE LOW DESPITE INTERVENTIONS. THE ORIENTING NURSE AND THE OTHER NURSE PERFORMED A BLADDER SCAN ON THE PATIENT WHICH SHOWED GREATER THAN 100ML IN THE BLADDER. THEY DISCUSSED WITH ANOTHER NURSE ON THE FLOOR HOW BEST TO TROUBLESHOOT THE FOLEY CATHETER, THEY FLUSHED IT BUT WERE NOT ABLE TO GET URINE BACK FROM IT. IT WAS ODD THAT IT SHOULD NEED TO BE FLUSHED AT ALL SINCE THE URINE WAS CLEAR (AS OPPOSED TO WHEN IT HAD SEDIMENT IN IT AND GOT CLOGGED MORE OFTEN). THEY THEN DEFLATED THE BALLOON, CLEANED THE PATIENT AND ADVANCED THE FOLEY FURTHER, WHICH ALSO DID NOT RESULT IN FREE FLOWING URINE. AT ANOTHER NURSES ENCOURAGEMENT THEY CHANGED THE FOLEY TO A DIFFERENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20199729 ↗
• MalfunctionFeb 24, 2023Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT 8 FRENCH FOLEY CATHETERS USED IN A PEDIATRIC CODE, FAILED WHEN ATTEMPTING TO INFLATE THE BALLOON DURING THE INSERTION ATTEMPTS. WHEN ANOTHER CATHETER WAS REMOVED AND INSPECTED, IT WAS NOTED THAT THERE WERE MULTIPLE HOLES IN THE CATHETER ITSELF AND THE BALLOON WAS UNABLE TO INFLATE. ANOTHER CATHETER WAS INSPECTED THAT WAS SENT DOWN FROM THE PEDIATRIC FLOOR AND THE SAME ISSUE WAS NOTED WITH THEIR SUPPLY AS WELL. THE 10 FRENCH FOLEY CATHETERS WERE NOT NOTED TO HAVE MALFUNCTIONED, BUT COULD NOT BE USED AS THEY WERE TOO SMALL FOR THE PATIENT. THIS ISSUE CAUSED THE INTUBATED PEDIATRIC PATIENT TO NOT HAVE A FOLEY CATHETER IN PLACE PRIOR TO BEING FLOWN OUT TO ANOTHER HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16435463 ↗
• MalfunctionNov 6, 2019Inaccurate Flow Rate; Infusion or Flow Problem; Inaccurate Flow Rate

  IT WAS REPORTED THAT BALLOON ON THE FOLEY CATHETER WAS FILLED TO 5CC BUT THE URINE WOULD NOT DRAIN. THE BALLOON WAS THEN DEFLATED AND THE URINE STARTED TO DRAIN. THE CATHETER WAS THEN REMOVED AND REPLACED.

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

  MAUDE report 9286111 ↗
• MalfunctionAug 21, 2019Inflation Problem; Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT IT WAS DIFFICULT TO INFLATE.

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

  MAUDE report 8917685 ↗
• MalfunctionApr 8, 2019Deflation Problem; Fluid/Blood Leak; Device Dislodged or Dislocated; Deflation Problem

  IT WAS REPORTED THAT THE CATHETER FELL OUT OF THE PATIENT ALLEGEDLY DUE TO WATER LEAKAGE.

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

  MAUDE report 8492809 ↗
• MalfunctionFeb 1, 2019Device Damaged Prior to Use; Material Integrity Problem; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOONED IN TWO AREAS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8298991 ↗
• MalfunctionOct 2, 2018Deflation Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THERE WAS A HOLE IN THE CATHETER BALLOON AND CAUSED PREMATURE DEFLATION.

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

  MAUDE report 7926558 ↗
• MalfunctionMay 2, 2018Failure to Infuse; Inflation Problem; Failure to Infuse

  IT WAS REPORTED THAT WATER COULD NOT BE INJECTED INTO THE BALLOON AND THE BALLOON COULD NOT BE INFLATED DURING A PRETEST.

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

  MAUDE report 7481490 ↗
• MalfunctionMay 1, 2018Device Damaged Prior to Use; Device Damaged Prior to Use; Material Deformation

  IT WAS REPORTED THAT THE CATHETER WAS DEFORMED. ALLEGEDLY, THE STRAIGHTENER EXTRUDED FROM EYE.

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

  MAUDE report 7476215 ↗
• MalfunctionJul 7, 2017Fluid/Blood Leak

  IT WAS REPORTED THAT A PATIENT WENT IN FOR AN OUTPATIENT VOIDING CYSTOURETHROGRAM, WHICH REQUIRED A FOLEY TO BE IN PLACE. THE FIRST ATTEMPT TO PLACE THE CATHETER FAILED. THE (B)(6) PATIENT WAS EXTREMELY UPSET AND TOOK 30+ MINUTES TO CALM DOWN. THE SECOND ATTEMPT WAS MADE WITH THREE PEOPLE HOLDING DOWN THE PATIENT WHILE THE REGISTERED NURSE (RN) PLACED THE CATHETER. THE PATIENT URINATED WHILE THE CATHETER WAS BEING PLACED, BUT URINE WAS ALSO COMING OUT OF THE CATHETER. A 5ML OF SALINE WAS PLACED IN THE BALLOON. THE CATHETER WAS TAPED TO THE PATIENT'S LEG. THE PATIENT WAS TAKEN TO RADIOLOGY FOR THE PROCEDURE. RADIOLOGY CALLED THE RN TO STATE THAT THE CATHETER WAS NOT IN PLACE. THE RN WENT TO RADIOLOGY AND CONFIRMED THAT THE CATHETER WAS OUT OF PLACE. THE RN TESTED THE BALLOON AND NOTICED A SMALL AMOUNT OF FLUID LEAKED FROM THE CATHETER.

  Patient problems: Discomfort; Pain

  MAUDE report 6693670 ↗