Bardex® Lubricath® Foley Catheter Councill Model 0196L16Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00801741017926), received between Dec 4, 2017 and Sep 10, 2026 — classified as 3 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50722283 ↗
• MalfunctionSep 4, 2026Material Puncture/Hole

  It was reported that Customer had experienced with at least three of our Bard Council Tip catheters. Instead of the balloon inflating at the tip of the catheter within the patient's bladder, it inflated at the fork where the syringe connection and foley bag attachment sites were located. For today¿s issue, the REF# is (b)(4) and the LOT# is NGLR3780. Customer also had issues where there was a leak at the Y junction and the fluid in the balloon port leaked out. They had two patient's council catheters fell out after surgery.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50620017 ↗
• MalfunctionSep 4, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50612422 ↗
• InjuryMar 4, 2026Material Puncture/Hole; Device Dislodged or Dislocated

  IT WAS REPORTED THAT WHEN THE WRITER WENT IN TO ASSESS THE PATIENT, NO DRAINAGE WAS NOTED IN THE FOLEY BAG. AT THE START OF THE SHIFT, A SMALL AMOUNT OF DRAINAGE HAD BEEN OBSERVED IN THE TUBING. THE WRITER ASKED THE PATIENT IF THE BAG HAD BEEN EMPTIED, AND THE PATIENT STATED THAT IT HAD NOT. THE FOLEY TUBING HAD BEEN ROUTED THROUGH THE PATIENT¿S PANTS, MAKING IT IMPOSSIBLE TO SEE WHETHER IT WAS SECURED IN THE LEG STRAP. A BLADDER SCAN SHOWED 800 ML. THE PATIENT REPORTED BEING COMFORTABLE AND DID NOT FEEL AN URGE TO VOID. WHEN THE PATIENT REMOVED THEIR PANTS, THE FOLEY CATHETER WAS FOUND TO BE OUT OF PLACE WITH THE BALLOON DEFLATED. NO TRAUMA WAS NOTED TO THE PENIS, AND THE PATIENT STATED THEY DID NOT FEEL ANY PAIN OR A ¿TUG¿ AND WERE UNSURE HOW IT HAPPENED. THE FOLEY CATHETER WAS PLACED IN A SPECIMEN BAG AND PROVIDED TO THE CNE.

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

  MAUDE report 24506147 ↗
• MalfunctionJan 30, 2026Difficult to Remove

  IT WAS REPORTED THAT THE CUSTOMER WAS UNABLE TO DEFLATE FOLEY CATHETER BALLOON TO REMOVE FROM PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223863 ↗
• MalfunctionDec 22, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT FOLEY CATHETER WOULD NOT DEFLATE FOR REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23871904 ↗
• MalfunctionApr 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE PATIENT THAT THE FOLEY CATHETERS ARE LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21839163 ↗
• MalfunctionOct 24, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT 60-YEAR-OLD MALE WITH HISTORY OF VRE (VANCOMYCIN-RESISTANT ENTEROCOCCI), SACRAL ULCER, LEFT FOOD ULCER, CAD (CORONARY ARTERY DISEASE), CKD (CHRONIC KIDNEY DISEASE), UNDERWENT SUPRAPUBIC FOLEY CATHETER PLACEMENT. WHILE PLACING CATHETER IN BLADDER VIA 20FR PEEL AWAY. FILLED BALLOON WITH STERILE WATER AND CONTRAST 50:50. UPON REMOVING PEEL AWAY, RECHECKED IMAGE, THE BALLOON LEAKED AND DEFLATED. HAD TO GET NEW PEEL AWAY AND COUNCIL-TIP CATHETER AND REPLACE THE PREVIOUS. NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20523816 ↗
• MalfunctionAug 27, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY CATHETER IN THE KIT HAD A SMALL HOLE AND WAS UNABLE TO FILL THE BALLOON. THE WATER KEPT COMING OUT AND THE CATHETER FELL OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20075269 ↗
• MalfunctionJul 18, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT CUSTOMER WAS NOT CLEAR AND DID NOT KNOW IF IT WAS A NON-DEFLATOR OR IF IT LEAKED BUT NURSES BELIEVED THERE WAS A HOLE IN THE FOLEY CATHETER BALLOON. IT WAS SAID THAT THE CATHETER FELL OUT OF THE PATIENT, IT WAS NOT CLEAR WHAT EXACTLY HAPPENED, BUT THE NURSE BELIEVED THERE TO BE A HOLE IN THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19772459 ↗
• MalfunctionApr 11, 2024Burst Container or Vessel; Material Rupture; Burst Container or Vessel; Material Rupture

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON POPPED WHILE IN PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19087279 ↗
• MalfunctionDec 22, 2023Fracture; Fracture

  IT WAS REPORTED THAT WATER LEAKED FROM THE FUNNEL OF THE FOLEY CATHETER WHEN STERILE DISTILLED WATER WAS INJECTED THROUGH THE VALVE USING A SYRINGE. IT WAS NOTED THAT THE THEY FOUND A CRACK IN THE FUNNEL.

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

  MAUDE report 18382948 ↗
• MalfunctionFeb 8, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON FAILED DUE TO LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16317809 ↗
• MalfunctionAug 9, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE CUSTOMER HAD AN ISSUE WITH THE FOLEY CATHETER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15190636 ↗
• InjuryMay 24, 2022Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE SUPRAPUBIC TUBE BALLOON WOULD NOT BE DEFLATED WHILE PHYSICIAN ATTEMPTED SUPRAPUBIC TUBE EXCHANGE AND IT WAS UNSUCCESSFUL. NURSE ATTEMPTED FLEXIBLE CYSTOSCOPY WITH MULTIPLE GRASPERS AND FOLEY CATHETER BALLOON WAS UNABLE TO PUNCTURE AND WAS ALSO UNABLE TO PLACE SPINAL NEEDLE TO PUNCTURE THE FOLEY BALLOON. STATED THAT THE PATIENT COULD NOT TOLERATE ANY MORE MANIPULATION AND WAS SENT TO THE OPERATING ROOM FOR ENDOSCOPIC BALLOON DEFLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14488734 ↗
• MalfunctionMay 4, 2022Failure to Deflate

  PHYSICIAN ATTEMPTED SUPRAPUBIC TUBE EXCHANGE. EXCHANGE WAS UNSUCCESSFUL. THE SUPRAPUBIC TUBE BALLOON WOULD NOT DEFLATE. ATTEMPTED FLEXIBLE CYSTOSCOPY WITH MULTIPLE GRASPERS AND KUMAR CATHETER UNABLE TO PUNCTURE THE BALLOON. UNABLE TO PLACE SPINAL NEEDLE TO PUNCTURE BALLOON. PATIENT COULD NOT TOLERATE ANYMORE MANIPULATION AND WAS SENT TO THE O.R. FOR ENDOSCOPIC BALLOON DEFLATION.

  Patient problems: Discomfort

  MAUDE report 14282264 ↗
• MalfunctionJan 17, 2022Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE WATER LEAKED OUT LITTLE BY LITTLE FROM THE FOLEY CATHETER EVEN AFTER INJECTING THE STERILIZED WATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13271562 ↗
• InjuryJul 2, 2020Material Rupture

  IT WAS REPORTED THAT THE CATHETER BALLOON SPONTANEOUSLY RUPTURED INSIDE THE PATIENT. THE PATIENT WAS HOSPITALIZED. PER ADDITIONAL INFORMATION RECEIVED 18JUN2020, THE CATHETER WAS PLACED IN A PATIENT THAT WAS ALREADY HOSPITALIZED. THE RUPTURED CATHETER WAS REMOVED FROM THE PATIENT AND ANOTHER CATHETER INSERTED PER UROLOGY. THE PATIENT LATER HAD A CYSTOSCOPY TO IDENTIFY AND REMOVE THE RETAINED FRAGMENT FROM THE INITIAL CATHETER BALLOON BURST. ONE PIECE WAS REMOVED.

  Patient problems: No Known Impact Or Consequence To Patient; Patient Problem/Medical Problem

  MAUDE report 10223760 ↗
• MalfunctionJun 19, 2018Inflation Problem; Failure to Infuse; Failure to Infuse

  I WAS REPORTED THAT THE USER WAS UNABLE TO INFLATE THE BALLOON OF THE CATHETER.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 7613524 ↗
• MalfunctionJun 18, 2018Deflation Problem; Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT IN SPITE SEVERING THE VALVE, THE BALLOON COULD NOT BE DEFLATED. THE SHAFT NEAR THE FUNNEL WAS CUTE AND THE BALLOON STILL COULD NOT BE DEFLATED. ON THE SAME DAY, THE SHAFT 4CM DISTAL FROM THE FUNNEL WAS SEVERED, AND WATER WAS ABLE TO BE WITHDRAWN AND THE CATHETER WAS REMOVED.

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

  MAUDE report 7610301 ↗
• MalfunctionFeb 23, 2018Misassembled; Material Discolored; Difficult to Insert; Misassembled

  IT WAS REPORTED THAT THE DRAINAGE EYE WAS NOT IN ITS STANDARD POSITION AND MADE IT DIFFICULT TO INSERT INTO THE PATIENT. PER THE PHOTO SAMPLE, THE CATHETER HAD BECOME DISCOLORED.

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

  MAUDE report 7292082 ↗
• MalfunctionJan 22, 2018Failure to Infuse

  IT WAS REPORTED THAT THE BALLOON OF THE CATHETER WOULD NOT INFUSE.

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

  MAUDE report 7209546 ↗
• MalfunctionDec 4, 2017Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE FOLEY CATHETER SEEMED THICKER THAN USUAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7080368 ↗