Bardex Lubricath Hematuria Foley CatheterRecalls & reported problems across all models

We found 5 models of Bardex Lubricath Hematuria Foley Catheter by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 68 adverse event reports in the FDA's MAUDE database, received between Oct 23, 2019 and Sep 25, 2026 — classified as 13 injuries, 55 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (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. 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 Hematuria Foley Catheter problems

Bardex Lubricath Hematuria Foley Catheter models

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

• Bardex® Lubricath® Hematuria Foley Catheter 2551H22

  CATHETER, UROLOGICAL
  27 reports
• Bardex® Lubricath® Hematuria Foley Catheter 2551H20

  CATHETER, UROLOGICAL
  24 reports
• Bardex® Lubricath® Hematuria Foley Catheter 2551H24

  CATHETER, UROLOGICAL
  8 reports
• Bardex® Lubricath® Hematuria Foley Catheter 2550H20

  CATHETER, UROLOGICAL
  5 reports
• Bardex® Lubricath® Hematuria Foley Catheter 2550H22

  CATHETER, UROLOGICAL
  4 reports

Recent Bardex Lubricath Hematuria 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 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 30, 2026Material Puncture/Hole

  IT WAS REPORTED THAT DURING USE THE FOLEY CATHETER STERILE WATER LEAKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24714046 ↗
• 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 ↗
• MalfunctionMar 16, 2026Inflation Problem; Inability to Irrigate

  IT WAS REPORTED THAT DURING PLACEMENT WHEN ATTEMPTING TO FILL THE FOLEY CATHETER BALLOON WITH STERILE WATER, THE WATER DID NOT ENTER. THE TROUBLESHOOTING PROCEDURE IN THE NOTICE DOCUMENT WAS NOT TRIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24613015 ↗
• MalfunctionFeb 20, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING PLACEMENT, DUE TO LOW URINE OUTPUT EVEN AFTER PLACEMENT, THE CATHETER WAS DISCONNECTED FROM THE DRAIN BAG THE CATHETER EXPERIENCED FOREIGN OBJECT CONTAMINATION WHEN, UPON DISCONNECTING THE CATHETER FROM THE DRAIN BAG AND ATTEMPTING TO ASPIRATE WITH THE CATHETER TIP, A FOREIGN OBJECT WAS FOUND CLOGGING THE INTERIOR OF THE DRAINAGE FUNNEL, AND THE LOT NUMBER WAS UNKNOWN/UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24406867 ↗
• MalfunctionFeb 12, 2026Difficult to Remove

  IT WAS REPORTED THAT AFTER PLACEMENT THE FOLEY CATHETER HAD DIFFICULTY IN WATER WITHDRAWAL. THE SYRINGE WAS MADE BY ANOTHER COMPANY AND WOULD BE INCLUDED IN THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24326345 ↗
• 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 17, 2026Difficult to Remove

  IT WAS REPORTED THAT DURING USE THE FOLEY CATHETER HAD DIFFICULTY IN WATER INJECTION AND WATER WITHDRAWAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24105489 ↗

Other C. R. Bard, Inc. products

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