Bardex® Foley Catheter Silicone Coated 0167V18SRecalls & reported problems

Summary

The FDA's MAUDE database contains 116 adverse event reports that list this exact device (DI 00801741019210), received between May 27, 2020 and Sep 28, 2026 — classified as 3 injuries, 113 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (53 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 116 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Material Rupture

  It was reported that On September 11, the patient underwent a partial transurethral plasmakinetic resection of the prostate under general anesthesia due to prostatic hyperplasia. Postoperatively, an indwelling urinary catheter was maintained with continuous bladder irrigation to facilitate urine drainage and prevent catheter obstruction caused by blood clots. During the morning handover on September 12 (postoperative day 1), the catheter was found to have dislodged. Upon inspection, the retention balloon was observed to be ruptured; the on-duty physician was immediately notified. Following the dislodgement, the patient was unable to void spontaneously and complained of lower abdominal distension and discomfort; a urinary catheter was subsequently reinserted at the bedside, draining pale red urine. Explanations and reassurance were provided to the patient and their family, and relevant precautions were outlined; the family expressed their understanding.

  Patient problems: Abdominal Distention; Discomfort; Hematuria

  MAUDE report 50916292 ↗
• MalfunctionSep 15, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50777733 ↗
• MalfunctionAug 28, 2026Material Fragmentation; Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50501978 ↗
• MalfunctionAug 27, 2026Partial Blockage; Complete Blockage

  It was reported that On (b)(6) 2026, a nurse performed a urinary catheterization on a patient as ordered by a physician. During the procedure, the nurse discovered that the drainage port at the distal end of the catheter was blocked. After several attempts to flush the catheter, fluid still could not be drained, so the nurse immediately replaced the catheter with a new one. After the replacement, the catheter functioned normally.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50482354 ↗
• MalfunctionAug 14, 2026Inaccurate Flow Rate; Patient Device Interaction Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions; Urinary Incontinence

  MAUDE report 50261297 ↗
• MalfunctionAug 12, 2026Material Rupture

  It was reported that during use the Foley catheter balloon ruptured.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50223795 ↗
• MalfunctionAug 4, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50130666 ↗
• MalfunctionJun 19, 2026Material Rupture

  IT WAS REPORTED THAT THE PATIENT HAD A FOLEY CATHETER PLACED AFTER SURGERY AND ON 17JUN2026, THE BALLOON RUPTURED, CAUSING THE CATHETER TO COME OUT. IT WAS REPLACED IMMEDIATELY AND THEN DISCONTINUED, WITHOUT CAUSING ANY OBVIOUS HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25566054 ↗
• MalfunctionJun 10, 2026Material Rupture

  IT WAS REPORTED THAT THE PATIENT'S URINARY CATHETER WAS DISLODGED, AND THE AIR BAG WAS FOUND TO BE RUPTURED. IMMEDIATELY, THE INTEGRITY OF THE AIR BAG WAS CHECKED, AND THERE WAS NO RESIDUAL DEBRIS, WHICH WAS REPORTED TO THE DOCTOR, AND THE URINARY CATHETER WAS GIVEN TO BE REINTRODUCED, AND THE CONSUMABLE ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25453160 ↗
• MalfunctionMay 28, 2026Device Contamination with Chemical or Other Material; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2026, FOR THE PATIENT CATHETERIZATION PROCESS TO OPEN THE CATHETERIZATION BAG FOUND CATHETER WHITE IMPURITIES, TIMELY REPLACEMENT OF A NEW CATHETERIZATION BAG TO CONTINUE TO CATHETERIZE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25323321 ↗
• MalfunctionMay 15, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS ON THE SECOND DAY OF INDWELLING FOLEY CATHETER CATHETERIZATION. ON THE EVENT DAY AT 10:50, WHILE RESTING IN BED, THE PATIENT COMPLAINED OF FLUID FLOWING FROM THE URETHRAL OPENING AND IMMEDIATELY INFORMED THE NURSING STAFF. UPON EXAMINATION, THE CATHETER WAS FOUND TO BE DISLODGED. THE CATHETER BALLOON WAS INTACT WITH NO RUPTURE, AND THERE WAS NO SALINE INSIDE. THE PATIENT HAD NO URETHRAL INJURY. THE DOCTOR WAS NOTIFIED, AND IT WAS CONFIRMED WITH THE DOCTOR THAT 20ML OF SALINE HAD BEEN INJECTED INTO THE CATHETER BALLOON DURING INSERTION. THE PROCEDURE WAS PERFORMED CORRECTLY. THE PATIENT WAS COMFORTED, GIVEN HEALTH EDUCATION, ADVISED DRINKING MORE WATER, ENCOURAGED TO URINATE ON THEIR OWN, AND THEIR URINE OUTPUT WAS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25185110 ↗
• MalfunctionApr 30, 2026Complete Blockage

  IT WAS REPORTED THAT THE ISSUE OF THE WATER INJECTION END OF THE TRIPLE LUMEN FOLEY CATHETER BEING BLOCKED AND UNABLE TO INJECT WATER DURING DEPARTMENT USE WAS MAINLY CONCENTRATED IN THE 123418C MODEL. THE DEPARTMENT HAS BEEN USING IT FOR MANY YEARS AND REPORTS THAT THERE ARE NO PROBLEMS WITH THE OPERATION. THIS WAS THE THIRD INCIDENT OF THE SAME PRODUCT OCCURRING IN THE SAME HOSPITAL WITHIN A SHORT PERIOD OF TIME. PLEASE CHECK EXACTLY WHERE THE PROBLEM LIES TO AVOID AFFECTING THE PRODUCT'S REPUTATION IN THE DEPARTMENT. LOT MYJW0962 AND LOT UNK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25044843 ↗
• MalfunctionApr 25, 2026Inflation Problem

  IT WAS REPORTED THAT THE ISSUE OF THE WATER INJECTION END OF THE TRIPLE-LUMEN FOLEY CATHETER BEING BLOCKED AND UNABLE TO INJECT WATER DURING DEPARTMENT USE WAS MAINLY CONCENTRATED IN THE 123418C MODEL. THE DEPARTMENT HAS BEEN USING IT FOR MANY YEARS AND REPORTS THAT THERE ARE NO PROBLEMS WITH THE OPERATION. THIS WAS THE THIRD INCIDENT OF THE SAME PRODUCT OCCURRING IN THE SAME HOSPITAL WITHIN A SHORT PERIOD OF TIME. PLEASE CHECK EXACTLY WHERE THE PROBLEM LIES TO AVOID AFFECTING THE PRODUCT'S REPUTATION IN THE DEPARTMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24993086 ↗
• MalfunctionApr 12, 2026Material Rupture

  IT WAS REPORTED THAT THE PATIENT HAD AN 18" SIZE BARD FOLEY CATHETER INDWELLED ACCORDING TO MEDICAL ADVICE. FOUR HOURS AFTER INDWELLING, THE CATHETER CAME OUT BY ITSELF, AND EXAMINATION CONFIRMED THAT THE BALLOON WAS RUPTURED. AFTER VERIFICATION, IT WAS DETERMINED TO BE A CATHETER QUALITY ISSUE, AND THE CATHETER WAS IMMEDIATELY REPLACED FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24852952 ↗
• MalfunctionApr 8, 2026Material Rupture

  IT WAS REPORTED BY THE DEPARTMENT THAT DURING USE THE FOLEY CATHETER FACED OCCASIONAL INSTANCES OF CATHETER BALLOON RUPTURE PRIMARILY INVOLVING THE 123418C MODEL. THE DEPARTMENT HAS BEEN USING THIS PRODUCT FOR MANY YEARS AND REPORTS NO ISSUES WITH ITS OPERATION. THIS IS THE SECOND INSTANCE OF A RUPTURE INVOLVING THE SAME PRODUCT AT THE SAME HOSPITAL WITHIN A SHORT PERIOD OF TIME . PLEASE INVESTIGATE THE ROOT CAUSE TO AVOID DAMAGING THE PRODUCT'S REPUTATION WITHIN THE DEPARTMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24816052 ↗
• MalfunctionApr 8, 2026Material Rupture

  IT WAS REPORTED THAT OCCASIONAL BALLOON RUPTURES OF THE FOLEY CATHETER OCCUR DURING DEPARTMENTAL USE, MAINLY CONCENTRATED IN MODEL 123418C. THE DEPARTMENT HAS BEEN USING IT FOR MANY YEARS AND REPORTS NO ISSUES WITH THE OPERATION. THIS WAS THE SECOND RUPTURE OF THE SAME PRODUCT IN THE SAME HOSPITAL WITHIN A SHORT PERIOD. PLEASE INVESTIGATE WHERE THE PROBLEM LIES TO PREVENT IT FROM AFFECTING THE PRODUCT'S REPUTATION IN THE DEPARTMENT. PATIENT HAD DELAY IN SURGERY AND ALSO WAS CONTAMINATED WITH BODILY FLUID.

  Patient problems: Exposure to Body Fluids

  MAUDE report 24816049 ↗
• MalfunctionApr 2, 2026Difficult to Remove

  IT WAS REPORTED THAT WATER INSIDE THE FOLEY CATHETER BALLOON COULD NOT BE COMPLETELY WITHDRAWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24768548 ↗
• MalfunctionMar 31, 2026Material Puncture/Hole

  IT WAS REPORTED THAT, ON THE SECOND DAY AFTER A SINGLE-USE STERILE URINARY FOLEY CATHETER WAS INSERTED FOR THE PATIENT, AT 10:50 A.M. WHILE RESTING IN BED, THE PATIENT REPORTED FLUID LEAKING FROM THE URETHRAL OPENING. THE PATIENT IMMEDIATELY NOTIFIED THE NURSING STAFF. UPON EXAMINATION, THE FOLEY CATHETER WAS FOUND TO HAVE SLIPPED OUT. THE CATHETER BALLOON WAS INTACT WITH NO RUPTURE, AND THE SALINE SOLUTION HAD BEEN COMPLETELY DRAINED. THE PATIENT HAD NO URETHRAL INJURY. THE INCIDENT WAS REPORTED TO THE PHYSICIAN, WHO CONFIRMED THAT 20 ML OF SALINE HAD BEEN INJECTED INTO THE BALLOON DURING CATHETER INSERTION, CONFIRMING THAT THE PROCEDURE WAS PERFORMED ACCORDING TO STANDARD PROTOCOL. THE PATIENT WAS REASSURED AND PROVIDED WITH HEALTH EDUCATION, ADVISED DRINKING PLENTY OF FLUIDS, AND ENCOURAGED TO ATTEMPT SPONTANEOUS URINATION. URINATION STATUS WAS MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24744007 ↗
• MalfunctionMar 24, 2026Material Rupture

  IT WAS REPORTED THAT THE DEPARTMENT HAD REPORTED OCCASIONAL INSTANCES OF CATHETER BALLOON RUPTURE DURING USE. THE DEPARTMENT HAS BEEN USING THIS PRODUCT FOR MANY YEARS AND REPORTS NO ISSUES WITH ITS OPERATION. PLEASE INVESTIGATE THE ROOT CAUSE OF THE PROBLEM TO AVOID DAMAGING THE PRODUCT¿S REPUTATION WITHIN THE DEPARTMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24677621 ↗
• MalfunctionMar 23, 2026Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BLADDER IRRIGATION WITH 3000 ML OF SALINE AT 5:00 PM. AT 6:55 PM, UNDER LOCAL ANESTHESIA, A 'CYSTOSCOPY VIA LOWER BLADDER APPROACH' WAS PERFORMED, AND A DISPOSABLE STERILE FOLEY CATHETER WAS INSERTED. AFTERWARDS, THE PATIENT EXPERIENCED A PROLONGED PERIOD WITHOUT URINATION. UPON INSPECTION, THE CATHETER WAS FOUND TO HAVE DISLODGED, AND THE BALLOON OF THE CATHETER HAD RUPTURED. A NEW CATHETER WAS THEN REPLACED.

  Patient problems: Discomfort; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24670816 ↗
• MalfunctionMar 21, 2026Complete Blockage

  IT WAS REPORTED THAT DURING USE THE FOLEY CATHETER IRRIGATION LUMEN WAS BLOCKED AND SALINE COULD NOT PASS THROUGH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24657047 ↗
• MalfunctionMar 11, 2026Material Puncture/Hole

  IT WAS REPORTED THAT ON (B)(6) 2026 AT 20:00, DURING USE, THE SINGLE-USE STERILE URINARY CATHETER (LOT NO. MYHW0894, 18FR) MALFUNCTIONED AS THE BALLOON FAILED TO INFLATE WHEN THE PRESCRIBED AMOUNT OF STERILE SALINE WAS INJECTED INTO THE URINARY TUBING BLADDER FOR FIXATION, AND LEAKAGE OF THE BLADDER BALLOON WAS CONFIRMED PREVENTING COMPLETION OF FIXATION; THE MALFUNCTIONING CATHETER WAS SLOWLY WITHDRAWN TO AVOID SECONDARY INJURY, DURING WHICH A SMALL AMOUNT OF FRESH BLEEDING WAS OBSERVED AT THE PATIENT¿S URETHRA AND THE PATIENT REPORTED OBVIOUS URETHRAL PAIN, AFTER WHICH THE CATHETER WAS IMMEDIATELY REPLACED WITH A NEW DEVICE AND THE INDWELLING CATHETERIZATION PROCEDURE WAS COMPLETED ACCORDING TO THE DOCTOR¿S ORDERS WITH SUBSEQUENT BLADDER IRRIGATION AND PROPER FIXATION OF THE URETHRA AND DRAINAGE BAG.

  Patient problems: Genital Bleeding; Pain

  MAUDE report 24571677 ↗
• MalfunctionMar 10, 2026Material Rupture

  IT WAS REPORTED THAT DURING USE IN THE DEPARTMENT, THE FOLEY CATHETER BALLOON RUPTURED. THE MODEL WAS 123418C. THE DEPARTMENT HAD BEEN USING IT FOR MANY YEARS AND STATED THAT THERE WERE NO ISSUES WITH THE OPERATION SO NEED TO CHECK TO SEE EXACTLY WHERE THE PROBLEM OCCURRED TO AVOID AFFECTING THE PRODUCT'S REPUTATION IN THE DEPARTMENT. PER NOTIFICATION FROM INVESTIGATOR ON 06MAR2026, IT WAS REPORTED THAT ADDITIONAL SAMPLE WITH BALLOON RUPTURE WAS RETURNED FOR EVALUATION WAS FOUND DURING SAMPLE EVALUATION ON 14FEB2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24561343 ↗
• MalfunctionMar 5, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT CAME TO THE OUTPATIENT CLINIC FOR FOLEY CATHETER CATHETERIZATION ON (B)(6) 2026, AND THE NEXT DAY THE PATIENT NOTICED THAT THE CATHETER WAS LEAKING URINE FROM ONE LUMEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24521643 ↗
• MalfunctionFeb 27, 2026Material Rupture

  IT WAS REPORTED THAT ON (B)(6) 2026, AT 12:30 PM, THE PATIENT CAME TO THE NURSE'S STATION AND REPORTED FEELING THE URGE TO URINATE. WHILE GOING TO THE BATHROOM, THE URINARY FOLEY CATHETER DISLODGED ON ITS OWN. THE PATIENT WAS IN GENERALLY GOOD CONDITION AND ALERT, REPORTING NO DISCOMFORT. THE PATIENT WAS IMMEDIATELY ASSISTED BACK TO BED, INSTRUCTED TO LIE FLAT, AND THE URETHRAL OPENING WAS CHECKED FOR LACERATIONS OR ULCERS; NONE WERE FOUND. THE CATHETER BALLOON WAS FOUND TO BE DAMAGED, BUT THE RUPTURE WAS INTACT. THE DOCTOR WAS INFORMED IMMEDIATELY. AT 12:40 PM, FOLLOWING THE DOCTOR'S ORDERS, AN 18F TRIPLE LUMEN CATHETER WAS REINSERTED. URINE FLOW WAS CLEAR AND DARK RED, WITH APPROXIMATELY 200ML COLLECTED. 20ML OF SALINE WAS INFUSED INTO THE BALLOON, AND THE CATHETER WAS SECURED IN PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24475398 ↗