Bardex® Lubricath® Foley Catheter Councill Model 0196L18Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00801741017933), received between Jul 11, 2017 and Jul 31, 2026 — classified as 1 injury, 19 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (6 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2026Inaccurate Flow Rate; Nonstandard Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50105790 ↗
• MalfunctionJun 24, 2025Material Rupture; Material Rupture

  CUSTOMER SAID THAT THE BALLOON POPPED. PATIENT EMAIL ADDRESS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22324974 ↗
• MalfunctionDec 3, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON WOULD NOT INFLATE. THEY TRIED ON BACK CABLE TOO AND IT WOULD NOT INFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20832661 ↗
• MalfunctionNov 21, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON WAS NOTED TO BE DEFLATED AND WHEN FILLING THE BALLOON, IT WAS NOTED THAT FLUID WAS LEAKING OUT OF THE BALLOON LUMEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20745380 ↗
• MalfunctionSep 16, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE FOLEY CATHETER INFLATION VALVE COVER WAS NOT PROPERLY FITTED SO IT WAS DISCONTINUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20223412 ↗
• MalfunctionAug 22, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT PATIENT HAD A FOLEY CATHETER INSERTED DURING THEIR 8AM APPOINTMENT. PATIENT RETURNED TO CLINIC AROUND NOON BECAUSE THEIR CATHETER HAD FALLEN OUT. THEY STILL HAD THE CATHETER ATTACHED TO THEIR STATLOCK. THE BALLOON WAS NOTED TO BE DEFLATED. WHEN FILLING THE BALLOON, IT WAS NOTED THAT FLUID WAS LEAKING OUT OF THE BALLOON LUMEN. FOLEY SAVED FOR INVESTIGATION, SO THEY SEALED FOLEY IN PLASTIC BAG ALONG WITH PACKAGING. NO HARM TO THE PATIENT HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20039015 ↗
• MalfunctionMay 6, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE BALLOON INFLATION PORT ON FOLEY CATHETER WAS MISSING AND SO THE PRODUCT WOULD NOT INFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19249286 ↗
• MalfunctionJan 30, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE PATIENT HAD AN OPTILUME PROCEDURE ON (B)(6) 2023, AT APPR. 1400-HRS. AT METHODIST HOSPITAL IN THE WOODLANDS, TEXAS. A FOLEY CATHETER, SUPPLIED BY THE HOSPITAL, WAS INSTALLED AS POSTOPERATIVE CARE TO ALLOW FOR SUFFICIENT TIME FOR THE IMPACTED SECTION OF THE URETHRA TO HEAL. THE FOLEY CATHETER BALLOON FAILED ON FRIDAY DECEMBER 8 AT ABOUT 0800-HRS., APPROXIMATELY 64-HRS. AFTER INSTALLATION. THE BALLOON SECTION OF THE CATHETER FAILED AFTER APPR. 64-HRS AND THE CATHETER DROPPED OUT FOLLOWING A COUGH. ALSO STATED THAT THE CATHETER BALLOON HAD BEEN TESTED WITH A 5-CC SYRINGE PRIOR TO INSTALLATION. THE CATHETER BALLOON HAD BURST AND NO MISSING PIECES WERE FOUND. PER FOLLOW UP VIA EMAIL ON 11JAN2024, IT WAS REPORTED THAT NO REPLACEMENT CATHETER WAS INSTALLED. PATIENT WAS CONCERNED WITH THE REDUCED HEALING TIME SINCE THE RECOMMENDATION WAS 5-DAYS. THEY STATED THAT THEY WERE UNABLE TO SELF CATH TWO TO FOUR DAYS BEFORE THE STREAM STARTED TO DIMINISH AND HAD TO RESTART SELF CATHING. THEY WERE NOW USING FOUR TO SIX CATHETERS A DAY. PER FOLLOW UP VIA EMAIL ON 11JAN2024, IT WAS REPORTED THAT NO REPLACEMENT CATHETER WAS PLACED. IN THE MORNING OF DECEMBER 08 THAT THEY WOULD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18605348 ↗
• MalfunctionNov 10, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE CUSTOMER HAD 2 FOLEY CATHETERS, WHERE THE BALLOON DEVELOPED A CRACK ON (B)(6) 2021. THEY REPLACED IT WITH A SECOND ONE AND IT DID THE SAME THING. THERE WAS NO EXPOSURE TO THE PATIENT OR TO THE HEALTH CARE WORKER AND NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12787755 ↗
• MalfunctionNov 10, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THE CUSTOMER HAD 2 FOLEY CATHETERS WHERE THE BALLOON DEVELOPED A CRACK. THEY REPLACED CATHETER WITH A SECOND ONE AND IT DID THE SAME THING. THERE WAS NO EXPOSURE TO THE PATIENT OR TO THE HEALTH CARE WORKER AND NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12787620 ↗
• MalfunctionMar 22, 2021Material Twisted/Bent; Component Misassembled; Material Twisted/Bent; Component Misassembled

  IT WAS REPORTED THAT THE SHAPE OF THE FUNNEL NEAR THE VALVE AREA WAS FOUND TO BE DEFORMED WHEN THE PACKAGE WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11542444 ↗
• MalfunctionOct 17, 2019Material Deformation; Device Fell; Material Deformation

  IT WAS REPORTED THAT THE CATHETER FELL OUT OF THE PATIENT THE NEXT DAY AFTER PLACEMENT. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON (B)(6) 2019 FROM IBC REPRESENTATIVE, THERE WAS NO DAMAGED TO THE CATHETER. PER SAMPLE EVALUATION, THE BALLOON WAS FOUND TO BE ASYMMETRIC.

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

  MAUDE report 9202062 ↗
• MalfunctionOct 1, 2019Deflation Problem; Device Fell; Deflation Problem

  IT WAS REPORTED THAT THE CATHETER FELL OUT OF THE PATIENT THE NEXT DAY AFTER PLACEMENT. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 18 SEPTEMBER 2019 FROM IBC REPRESENTATIVE, THERE WAS NO DAMAGED TO THE CATHETER. PER SAMPLE EVALUATION, THE BALLOON WAS FOUND TO BE ASYMMETRIC.

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

  MAUDE report 9142083 ↗
• MalfunctionSep 6, 2018Deflation Problem; Positioning Failure; Use of Device Problem; Detachment of Device or Device Component; Use of Device Problem

  IT WAS REPORTED THAT THE CATHETER WAS PLACED INTRAOPERATIVELY AND THE PATIENT WAS ABLE TO DISCHARGED; HOWEVER, WHEN THE CATHETER REMOVED AT A LATER DATE, THE BALLOON DEFLATED AND CAME OUT OF THE PATIENT PREMATURELY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7850787 ↗
• MalfunctionJun 5, 2018Deflation Problem; Device Dislodged or Dislocated; Deflation Problem

  IT WAS REPORTED THAT THE CATHETER FELL OUT OF THE PATIENT WITH A DEFLATED BALLOON JUST AFTER PLACEMENT.

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

  MAUDE report 7568806 ↗
• MalfunctionNov 14, 2017Deflation Problem; Fluid/Blood Leak

  IT WAS REPORTED THAT CATHETER FELL OUT OF THE PATIENT WITH A DEFLATED BALLOON DUE TO WATER LEAKAGE. THIS EVENT OCCURRED ON THE DAY OF PLACEMENT. THE CATHETER WAS INSERTED INTO THE PATENT AT A UROLOGY OUTPATIENT DEPARTMENT.

  Patient problems: No Code Available

  MAUDE report 7028861 ↗
• MalfunctionAug 31, 2017Complete Blockage; Deflation Problem; No Device Output

  IT WAS REPORTED THAT A PATIENT HAD A CYSTOSCOPY WITH A RESECTION OF THE PROSTATE, FOR URINE RETENTION, ON (B)(6) 2017. THE PATIENT DID WELL AND WENT HOME WITH A SUPRAPUBIC CATHETER IN CASE HE COULD NOT VOID PER HIS URETHRA. AFTER BEING HOME FOR SEVERAL DAYS, HE STARTED HAVING INTERMITTENT BOUTS OF HEMATURIA AND THIS STARTED AFTER THE PATIENT STARTED TAKING HIS PLAVIX. HE WAS THEN REMOVED FROM THE MEDICATION. HE WAS SEEN IN THE PHYSICIAN'S OFFICE AND WAS FOUND TO BE DOING WELL VOIDING AND EMPTYING THE SUPRAPUBIC CATHETER TO CHECK FOR RESIDUAL URINE. THE DAY BEFORE THE PATIENT HAD TO GO TO SURGERY, HE STATED THAT HE HAD LIFTED GROCERIES AND HEAVY CAT LITTER, AGAIN DEVELOPING HEMATURIA. ON (B)(6) 2017, THE PATIENT WENT TO THE EMERGENCY ROOM AFTER EXPERIENCING THE HEMATURIA. THE PATIENT STATED HE WAS UNABLE TO DRAIN THE SUPRAPUBIC CATHETER AND HIS WIFE HAD FLUSHED IT AND HAD GOTTEN NO RETURN. THE UROLOGIST WAS CALLED TO EVALUATE THE PATIENT. THE UROLOGIST DECIDED TO REMOVE THE SUPRAPUBIC CATHETER SINCE IT APPEARED TO BE CLOGGED AND THE PATIENT WAS VOIDING THROUGH HIS URETHRA. THE UROLOGIST DID ATTEMPT TO FLUSH THE CATHETER AS WELL, AND THE FLUID WOULD NOT ASPIRATE BACK. THE UROLOGIST T

  Patient problems: Hematuria

  MAUDE report 6835664 ↗
• InjuryAug 29, 2017Deflation Problem

  IT WAS REPORTED THAT A PATIENT HAD A CYSTOSCOPY WITH A RESECTION OF THE PROSTATE ON (B)(6) 2017. ON (B)(6) 2017 THE PATIENT WENT TO THE EMERGENCY ROOM AFTER EXPERIENCING HEMATURIA. THE UROLOGIST ATTEMPTED TO DEFLATE THE BALLOON ON THE SUPRAPUBIC CATHETER, AND IT WOULD NOT DEFLATE. THE PATIENT WENT TO THE OR FOR A CYSTOSCOPY, AND THE BALLOON WAS PIERCED USING A NEEDLE THROUGH THE CYSTOSCOPE TO DEFLATE IT. CLOTS WERE REMOVED AS WELL. IT WAS LATER REPORTED FROM THE FACILITY THAT THE ORIGINAL PROCEDURE (RESECTION OF THE PROSTATE) WAS DONE FOR URINE RETENTION. THE PATIENT DID WELL AND WENT HOME WITH A SUPRAPUBIC CATHETER IN CASE HE COULD NOT VOID PER HIS URETHRA. AFTER BEING HOME FOR SEVERAL DAYS, HE STARTED HAVING INTERMITTENT BOUTS OF HEMATURIA AND THIS STARTED AFTER THE PATIENT STARTED TAKING HIS PLAVIX. HE WAS THEN REMOVED FROM THE MEDICATION. HE WAS SEEN IN THE PHYSICIAN'S OFFICE AND WAS FOUND TO BE DOING WELL VOIDING AND EMPTYING THE SUPRAPUBIC CATHETER TO CHECK FOR RESIDUAL URINE. THE DAY BEFORE THE PATIENT HAD TO GO TO SURGERY, HE STATED THAT HE HAD LIFTED GROCERIES AND HEAVY CAT LITTER, AGAIN DEVELOPING HEMATURIA. HE CAME TO THE EMERGENCY DEPARTMENT DUE TO THE HEMATURIA. THE UR

  Patient problems: Hematuria

  MAUDE report 6827519 ↗
• MalfunctionAug 11, 2017Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS DAMAGE TO THE SHAFT; THE DEVICE WAS ALSO LEAKING WATER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6788726 ↗
• MalfunctionJul 11, 2017Inflation Problem

  IT WAS REPORTED THAT THE BALLOON ON THE CATHETER DID NOT STAY INFLATED WHEN THE WATER WAS INSERTED. THE WATER CAME OUT OF THE FUNNEL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6704920 ↗