Bardex® Lubricath® Hematuria Foley Catheter 2551H20Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00801741025143), received between Apr 1, 2022 and Sep 25, 2026 — classified as 8 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (8 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Inflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903546 ↗
• MalfunctionSep 18, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50829611 ↗
• MalfunctionSep 11, 2026Inflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50743255 ↗
• InjuryJun 12, 2026Difficult to Remove

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS USED AFTER TRANSURETHRAL RESECTION OF THE PROSTATE (TURP). THE CATHETER WITH LOT MYJT3484 COULD NOT BE REMOVED AFTER ONE WEEK OF PLACEMENT BECAUSE THE PATIENT WAS IN PAIN. COMPUTED TOMOGRAPHY (CT) CHECK REVEALED THAT THE BALLOON HAD BURST, AND NO STERILE WATER WAS INSIDE. BECAUSE THE PATIENT WAS IN PAIN, IT WAS REMOVED UNDER GENERAL ANESTHESIA. THERE WAS CONTACT STATING THAT THE PATIENT WAS ANGRY AND THEY WERE STRUGGLING WITH HOW TO HANDLE THE SITUATION. THERE WAS ALSO INFORMATION THAT LINDELONE WAS APPLIED AS A SUBSTITUTE FOR JELLY. MEDICAL INTERVENTION REQUIRED. PER ADDITIONAL INFORMATION RECEIVED ON 17APR2026, STATED THAT DURING THE PATIENT¿S SURGERY, URETHRAL DILATION WAS PERFORMED DUE TO SEVERE PENDULOUS URETHRAL STRICTURE. TO PREVENT POSTOPERATIVE URETHRAL RESTENOSIS AND REDUCE LOCAL INFLAMMATION, LINDELONE VG OINTMENT WAS APPLIED AT THE CONCLUSION OF THE SURGERY, AND THE PRODUCT WAS INSERTED WITH THE OINTMENT APPLIED TO THE EXTERNAL URETHRAL ORIFICE. REMOVAL WAS PERFORMED UNDER GENERAL ANESTHESIA. A PREOPERATIVE CT SCAN HAD ALREADY CONFIRMED THAT THE FIXATION FLUID HAD BEEN DRAINED. ALTHOUGH REMOVAL DURING AN OUTPATIENT VISIT WAS D

  Patient problems: Pain

  MAUDE report 25492215 ↗
• MalfunctionJun 12, 2026Material Rupture

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS USED AFTER TRANSURETHRAL RESECTION OF THE PROSTATE (TURP). THE CATHETER WITH LOT MYJT3484 COULD NOT BE REMOVED AFTER ONE WEEK OF PLACEMENT BECAUSE THE PATIENT WAS IN PAIN. COMPUTED TOMOGRAPHY (CT) CHECK REVEALED THAT THE BALLOON HAD BURST, AND NO STERILE WATER WAS INSIDE. BECAUSE THE PATIENT WAS IN PAIN, IT WAS REMOVED UNDER GENERAL ANESTHESIA. THERE WAS CONTACT STATING THAT THE PATIENT WAS ANGRY AND THEY WERE STRUGGLING WITH HOW TO HANDLE THE SITUATION. THERE WAS ALSO INFORMATION THAT LINDELONE WAS APPLIED AS A SUBSTITUTE FOR JELLY. MEDICAL INTERVENTION REQUIRED. PER ADDITIONAL INFORMATION RECEIVED ON 17APR2026, STATED THAT DURING THE PATIENT¿S SURGERY, URETHRAL DILATION WAS PERFORMED DUE TO SEVERE PENDULOUS URETHRAL STRICTURE. TO PREVENT POSTOPERATIVE URETHRAL RESTENOSIS AND REDUCE LOCAL INFLAMMATION, LINDELON VG OINTMENT WAS APPLIED AT THE CONCLUSION OF THE SURGERY, AND THE PRODUCT WAS INSERTED WITH THE OINTMENT APPLIED TO THE EXTERNAL URETHRAL ORIFICE. REMOVAL WAS PERFORMED UNDER GENERAL ANESTHESIA. A PREOPERATIVE CT SCAN HAD ALREADY CONFIRMED THAT THE FIXATION FLUID HAD BEEN DRAINED. ALTHOUGH REMOVAL DURING AN OUTPATIENT VISIT WAS DI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25492207 ↗
• InjuryJun 12, 2026Difficult to Remove

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS USED AFTER TRANSURETHRAL RESECTION OF THE PROSTATE (TURP). THE CATHETER WITH LOT MYJT3484 COULD NOT BE REMOVED AFTER ONE WEEK OF PLACEMENT BECAUSE THE PATIENT WAS IN PAIN. COMPUTED TOMOGRAPHY (CT) CHECK REVEALED THAT THE BALLOON HAD BURST, AND NO STERILE WATER WAS INSIDE. BECAUSE THE PATIENT WAS IN PAIN, IT WAS REMOVED UNDER GENERAL ANESTHESIA. THERE WAS CONTACT STATING THAT THE PATIENT WAS ANGRY AND THEY WERE STRUGGLING WITH HOW TO HANDLE THE SITUATION. THERE WAS ALSO INFORMATION THAT LINDELONE WAS APPLIED AS A SUBSTITUTE FOR JELLY. MEDICAL INTERVENTION REQUIRED. PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2026, STATED THAT DURING THE PATIENT¿S SURGERY, URETHRAL DILATION WAS PERFORMED DUE TO SEVERE PENDULOUS URETHRAL STRICTURE. TO PREVENT POSTOPERATIVE URETHRAL RESTENOSIS AND REDUCE LOCAL INFLAMMATION, LINDELONE VG OINTMENT WAS APPLIED AT THE CONCLUSION OF THE SURGERY, AND THE PRODUCT WAS INSERTED WITH THE OINTMENT APPLIED TO THE EXTERNAL URETHRAL ORIFICE. REMOVAL WAS PERFORMED UNDER GENERAL ANESTHESIA. A PREOPERATIVE CT SCAN HAD ALREADY CONFIRMED THAT THE FIXATION FLUID HAD BEEN DRAINED. ALTHOUGH REMOVAL DURING AN OUTPATIENT VISIT WAS

  Patient problems: Pain

  MAUDE report 25492203 ↗
• MalfunctionJun 12, 2026Material Rupture

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS USED AFTER TRANSURETHRAL RESECTION OF THE PROSTATE (TURP). THE CATHETER WITH LOT MYJT3484 COULD NOT BE REMOVED AFTER ONE WEEK OF PLACEMENT BECAUSE THE PATIENT WAS IN PAIN. COMPUTED TOMOGRAPHY (CT) CHECK REVEALED THAT THE BALLOON HAD BURST, AND NO STERILE WATER WAS INSIDE. BECAUSE THE PATIENT WAS IN PAIN, IT WAS REMOVED UNDER GENERAL ANESTHESIA. THERE WAS CONTACT STATING THAT THE PATIENT WAS ANGRY AND THEY WERE STRUGGLING WITH HOW TO HANDLE THE SITUATION. THERE WAS ALSO INFORMATION THAT LINDELONE WAS APPLIED AS A SUBSTITUTE FOR JELLY. MEDICAL INTERVENTION REQUIRED. PER ADDITIONAL INFORMATION RECEIVED ON 17APR2026, STATED THAT DURING THE PATIENT¿S SURGERY, URETHRAL DILATION WAS PERFORMED DUE TO SEVERE PENDULOUS URETHRAL STRICTURE. TO PREVENT POSTOPERATIVE URETHRAL RESTENOSIS AND REDUCE LOCAL INFLAMMATION, LINDELON VG OINTMENT WAS APPLIED AT THE CONCLUSION OF THE SURGERY, AND THE PRODUCT WAS INSERTED WITH THE OINTMENT APPLIED TO THE EXTERNAL URETHRAL ORIFICE. REMOVAL WAS PERFORMED UNDER GENERAL ANESTHESIA. A PREOPERATIVE CT SCAN HAD ALREADY CONFIRMED THAT THE FIXATION FLUID HAD BEEN DRAINED. ALTHOUGH REMOVAL DURING AN OUTPATIENT VISIT WAS DI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25492184 ↗
• MalfunctionMar 23, 2026Material Puncture/Hole; Material Rupture

  IT WAS REPORTED THAT DURING USE THE FOLEY CATHETER CAME OUT SIX DAYS AFTER BEING LODGED AS THERE WAS A HOLE IN THE CUFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24670815 ↗
• MalfunctionMar 21, 2026Material Puncture/Hole; Use of Device Problem

  IT WAS REPORTED THAT DURING USE OF A FOLEY CATHETER AFTER INCREASED THE CUFF VOLUME FROM 30 TO 50 CC (INCREASING BY 20), IT STARTED LEAKING AND THERE WAS A HOLE IN THE CUFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24656985 ↗
• MalfunctionFeb 6, 2026Material Puncture/Hole

  IT WAS REPORTED THAT DURING USE, THERE WAS SPONTANEOUS REMOVAL OF FOLEY CATHETER, SUSPECTED LUMEN-TO-LUMEN COMMUNICATION WITHIN THE FUNNEL. FOLEY CATHETER WAS PLACED AFTER UROLOGICAL SURGERY. SPONTANEOUS DISLODGEMENT DISCOVERED UPON RETURNING TO THE WARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24277694 ↗
• MalfunctionJan 8, 2026Material Puncture/Hole; Material Rupture

  IT WAS REPORTED THAT THERE WAS A HOLE IN THE CUFF. THE BALLOON CAME OUT A FEW DAYS AFTER INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24014906 ↗
• MalfunctionSep 15, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF A SOUND OF SOMETHING BREAKING, AND UPON INVESTIGATION, THE FOLEY CATHETER BALLOON WAS FOUND TO HAD BROKEN AND WAS REMOVED NATURALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23050999 ↗
• MalfunctionAug 12, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT FOLEY CATHETER PRODUCT OR PACKAGING WAS DAMAGED. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 11AUG2025, STATED THAT THE PRODUCT HAD NO INFLATION AND CONTAINED A SMALL LEAK HOLE AND NO PATIENT IMPACTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22784186 ↗
• MalfunctionJun 17, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT FOLEY CATHETER HAD BROKEN CAUSING URINE LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22234825 ↗
• InjuryJun 3, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT APPROXIMATELY 3 HOURS AFTER PLACEMENT, THE FOLEY CATHETER WAS NATURALLY REMOVED, AND WHEN THE CUFF WAS CHECKED, FOLEY CATHETER BALLOON HAD BURST. PART OF THE CUFF PART REMAINS INSIDE THE BLADDER. IT WAS REMOVED USING A CYSTOSCOPE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22132476 ↗
• InjuryJun 3, 2025Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE CRITICAL CARE NURSE IN THE ONLINE SURVEY STATED THAT THE PATIENT EXPERIENCED ADVERSE EVENTS (URINARY SYMPTOMS (DYSURIA, INFLAMMATION, ITCHING, BURNING, IRRITATION, FREQUENCY, URGENCY), ) ASSOCIATED WITH THE DEVICE 2551H18UK BARD HYDROGEL COATED PROSTATIC CATHETER, 3-WAY STRAIGHT TIP, 30/50ML, 18 FR. , UK ONLY, AND IT DID NOT RESULTED IN PATIENT INJURY REQUIRING MEDICAL OR SURGICAL INTERVENTION AND THE COMPLICATION WAS NOT PRESENT PRIOR TO DEVICE PLACEMENT. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 14MAY2025, ADDITIONALLY, THE RESPONDENT INDICATED THE PATIENT EXPERIENCED ANOTHER COMPLICATION AND STATED 'ALLERGY'. THE RESPONDENT INDICATED THEY BELIEVED THE ALLERGY TO BE DEVICE RELATED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Burning Sensation; Dysuria; Inflammation; Itching Sensation; Micturition Urgency; Skin Inflammation/ Irritation; Urinary Frequency / Polyuria

  MAUDE report 22131803 ↗
• InjuryMay 15, 2025Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE CRITICAL CARE NURSES REPORTED IN AN ONLINE SURVEY THAT THE PATIENT EXPERIENCED ADVERSE EVENTS ((URINARY SYMPTOMS (DYSURIA, INFLAMMATION, ITCHING, BURNING, IRRITATION, FREQUENCY, URGENCY)), ASSOCIATED WITH THE DEVICE 2551H18UK BARD HYDROGEL COATED PROSTATIC CATHETER, 3-WAY STRAIGHT TIP, 30/50ML, 18 FR. UK ONLY, AND IT DID NOT RESULTED IN PATIENT INJURY REQUIRING MEDICAL OR SURGICAL INTERVENTION AND THE COMPLICATION WAS NOT PRESENT PRIOR TO DEVICE PLACEMENT. ADDITIONALLY, THE RESPONDENT INDICATED THE PATIENT EXPERIENCED ANOTHER COMPLICATION AND STATED 'ALLERGY'. THE RESPONDENT INDICATED THEY BELIEVED THE ALLERGY TO BE DEVICE RELATED.

  Patient problems: Burning Sensation; Dysuria; Hypersensitivity/Allergic reaction; Inflammation; Itching Sensation; Micturition Urgency; Skin Inflammation/ Irritation; Urinary Frequency / Polyuria

  MAUDE report 22028025 ↗
• MalfunctionMar 18, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT WHEN INSERTING THE FOLEY CATHETER, THE VALVE CAME OFF WHEN STERILE WATER WAS INJECTED. SO, INSERTION WAS ABANDONED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21631844 ↗
• MalfunctionFeb 5, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE STERILE DISTILLED WATER LEAKED FROM THE FOLEY CATHETER DURING CUFF TEST IN OPERATING ROOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21312413 ↗
• MalfunctionJul 18, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A UROLOGICAL OPERATION, BLEEDING OCCURRED, SO RINDERON OINTMENT WAS APPLIED AND A FOLEY CATHETER BALLOON WAS PLACED. THE BALLOON WAS CONFIRMED TO HAVE BURST AND FALLEN OUT THE NEXT DAY IN THE 7TH WEST WARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19772878 ↗
• InjuryMay 16, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE SURVEY RESPONDENT MENTIONED THAT THE USER EXPERIENCED BLADDER PERFORATION WHILE USING THE HYDROGEL COATED PROSTATIC POST OPERATIVE CATHETER. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Perforation

  MAUDE report 14408194 ↗
• MalfunctionMay 16, 2022Decrease in Pressure; Material Puncture/Hole; Decrease in Pressure; Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS PLACED AFTER SURGERY AND ON THE NEXT DAY, THE CATHETER FELL OUT OF THE PATIENT. THE FORCEPS WAS NOT USED. PER FOLLOW-UP INFORMATION RECEIVED VIA IBC ON 10-MAY-2022, STATED THAT THERE WAS NO VISIBLE DAMAGE IN THE RETURNED SAMPLE AND THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14407530 ↗
• InjuryApr 1, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE CUSTOMER MENTIONED PAIN, URETHRAL OR BLADDER TRAUMA WHEN THEY WERE ASKED ABOUT COMPLICATIONS WHILE USING THE FOLEY CATHETER. ALSO THE CATHETER WAS BLOCKED. STATED THAT THE FOLEY CATHETER WAS ACCIDENTALLY REMOVED WHILE USING . IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

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

  MAUDE report 13973232 ↗
• InjuryApr 1, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE USER EXPERIENCED BACTERIURIA AND HEMATURIA WHEN ASKED OF COMPLICATIONS WHILE USING FOLEY CATHETER. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

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

  MAUDE report 13973157 ↗