Bardex Lubricath Pediatric Foley CatheterRecalls & reported problems across all models

We found 2 models of Bardex Lubricath Pediatric Foley Catheter by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 44 adverse event reports in the FDA's MAUDE database, received between Jul 7, 2017 and Sep 29, 2026 — classified as 6 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (9 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Bardex Lubricath Pediatric Foley Catheter problems

Bardex Lubricath Pediatric Foley Catheter models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Bardex® Lubricath® Pediatric Foley Catheter 0165PL10

  CATHETER, COUDE
  26 reports
• Bardex® Lubricath® Pediatric Foley Catheter 0165PL08

  CATHETER, COUDE
  18 reports

Recent Bardex Lubricath Pediatric Foley Catheter adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Burst Container or Vessel

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50940518 ↗
• MalfunctionSep 17, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50809608 ↗
• 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 ↗
• MalfunctionMay 1, 2026Incorrect Measurement

  IT WAS REPORTED THAT THE PATIENT CONTACTED CW SITE TO ADVISE THE FOLEY CATHETERS THEY RECEIVED ARE A DIFFERENT SIZE THAN PREVIOUSLY AND THEY ARE NOT ABLE TO USE IT. REVIEWING THE LOT NUMBERS PROVIDED WE DIDN'T SEND MYGW2925 AND HAD SPOKEN TO THE COLLEAGUE THIS WAS AN OLD PACKAGING, SO WAS NOT SURE WHERE THIS HAD COME FROM. THE PRODUCT CODES ARE THE SAME SO THEY SHOULD BE IDENTICAL AS THE PHOTOS DO MAKE ONE LOOK BIGGER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25062148 ↗
• 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 ↗
• MalfunctionNov 5, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT, DURING A PATIENT ROUND, THE BEDSHEETS WERE FOUND DAMP. THE PATIENT WAS IMMEDIATELY EXAMINED, REVEALING THAT THE URINARY FOLEY CATHETER HAD BECOME DISLODGED. UPON INSPECTION, THE CATHETER'S OVERALL STRUCTURE REMAINED INTACT, BUT THE BALLOON SECTION EXHIBITED PARTIAL EROSION AND LOSS.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23478293 ↗
• MalfunctionNov 4, 2025Material Rupture; Material Rupture

  T WAS REPORTED THAT THE FOLEY CATHETER BALLOON RUPTURED DURING USE. THE HOSPITAL REQUIRES PROMPT COMPENSATION FOR THE DEFECTIVE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23469676 ↗
• InjurySep 2, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE CUSTOMER SAYS PATIENT SEEN IN EMERGENCY DEPARTMENT DUE TO BEING UNABLE TO DEFLATE THE BALLOON IN THEIR CATH FOLEY LUBRICATH PED LATEX (ITEM # 165PL10). ALSO REPORTED THAT THIS IS THE SECOND PATIENT THAT HAS SEEN IN EMERGENCY DEPARTMENT EXPERIENCING THIS ISSUE WHICH THE SAME EXACT PRODUCT. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 30SEP2025, CUSTOMER WAS UNSURE OF WHICH BOX THE ITEM CAME FROM, SO THEY PROVIDED THE LOT #¿S FOR ALL THREE. NGKP1958, NGJZ0304, NGKS2469. NO PATIENT IDENTIFIERS WERE SHARED DUE TO IT BEING PROTECTED HEALTH INFORMATION (PHI). THE PATIENT EXPERIENCED AN EMERGENCY ROOM VISIT DUE TO THE REPORTED ISSUE. THE PATIENT HAS NOT EXPERIENCED ANY ISSUES SINCE. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22937312 ↗
• InjurySep 2, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE CUSTOMER SAYS PATIENT SEEN IN EMERGENCY DEPARTMENT DUE TO BEING UNABLE TO DEFLATE THE BALLOON IN THEIR CATH FOLEY LUBRICATH PED LATEX (ITEM # 165PL10). ALSO REPORTED THAT THIS IS THE SECOND PATIENT THAT HAS SEEN IN EMERGENCY DEPARTMENT EXPERIENCING THIS ISSUE WHICH THE SAME EXACT PRODUCT. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 30SEP2025, CUSTOMER WAS UNSURE OF WHICH BOX THE ITEM CAME FROM, SO THEY PROVIDED THE LOT #¿S FOR ALL THREE. NGKP1958, NGJZ0304, NGKS2469. NO PATIENT IDENTIFIERS WERE SHARED DUE TO IT BEING PROTECTED HEALTH INFORMATION (PHI). THE PATIENT EXPERIENCED AN EMERGENCY ROOM VISIT DUE TO THE REPORTED ISSUE. THE PATIENT HAS NOT EXPERIENCED ANY ISSUES SINCE. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22937085 ↗
• MalfunctionFeb 13, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT WHEN THE NURSE ON THE MIDDLE SHIFT INSPECTED THE WARD, FOUND THAT THE CATHETER IN BED 1443 HAD FALLEN OUT, AND IMMEDIATELY CHECKED AND FOUND THAT THE CATHETER BALLOON WAS BROKEN, AND THE URINARY CATHETER PROLAPSED OUT ON ITS OWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21375236 ↗
• MalfunctionFeb 4, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE WHEN THE MID SHIFT NURSE WAS PATROLLING THE WARD, THEY DISCOVERED THAT THE FOLEY CATHETER IN BED 1409 HAD FALLEN OUT. THEY CHECKED IMMEDIATELY AND FOUND THAT THE BALLOON OF THE CATHETER WAS DAMAGED AND THE CATHETER HAD FALLEN OUT ON ITS OWN, SO THEY REINSERTED THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21303428 ↗
• MalfunctionFeb 3, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT WHEN THE NIGHT SHIFT NURSE VISITED THE WARD, FOUND THAT THE FOLEY CATHETER OF BED 1443 HAD FALLEN OUT. IT WAS CHECKED IMMEDIATELY AND FOUND THAT THE CATHETER BALLOON WAS BROKEN, SO THE CATHETER PROLAPSED OUT ON ITS OWN, SO THE CATHETER WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21294336 ↗

Other C. R. Bard, Inc. products

• Bardex I.C. Foley Catheter26 models · 3,607 reports
• Bardex Lubricath Foley Catheter38 models · 1,670 reports · 1 recall
• Bardex Lubri-Sil I.C. All-Silicone Foley Catheter26 models · 1,518 reports
• Magic3 Coude Intermittent Catheter with Sure-Grip Sleeve5 models · 1,466 reports
• Magic3 Intermittent Catheter with Sure-Grip Sleeve14 models · 1,310 reports
• Bardia Foley Catheter Silicone Coated19 models · 1,283 reports
• PureWick Female External Catheter5 models · 1,184 reports
• Bardex All-Silicone Foley Catheter12 models · 1,170 reports