Bardex® Lubri-Sil® I.C. Temperature-Sensing All-Silicone Foley Catheter 119316Recalls & reported problems

Summary

The FDA's MAUDE database contains 198 adverse event reports that list this exact device (DI 00801741039850), received between Sep 12, 2018 and Sep 18, 2026 — classified as 3 injuries, 195 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (64 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 198 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Fitting Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50829612 ↗
• MalfunctionSep 14, 2026Material Puncture/Hole

  It was reported that in the North 6, the Foley catheter had spontaneous removal within a few days of placement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50753086 ↗
• MalfunctionAug 5, 2026Inability to Irrigate

  It was reported that the irrigation port of the 3 way Foley catheter was occluded and could not be irrigated. The user was exposed to hazardous, blood, or bodily fluids. Replacing the catheter resolved the issue.

  Patient problems: Exposure to Body Fluids

  MAUDE report 50148800 ↗
• MalfunctionJul 14, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25820566 ↗
• MalfunctionJun 27, 2026Material Puncture/Hole

  IT WAS REPORTED THAT DURING USE SPONTANEOUS REMOVAL OF THE FOLEY CATHETER WAS FOUND AFTER SURGERY. WHEN CHECKED, LEAKAGE WAS FOUND NEAR, VICINITY OF THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25646333 ↗
• MalfunctionJun 19, 2026Material Puncture/Hole

  IT WAS REPORTED THAT A FOLEY CATHETER WAS INSERTED IN THE OPERATING ROOM FOR URINARY DRAINAGE AND TEMPERATURE MANAGEMENT; IT WAS SUBSEQUENTLY MANAGED IN THE INTENSIVE CARE UNIT BUT WAS FOUND TO HAVE BEEN ACCIDENTALLY DISLODGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25563761 ↗
• MalfunctionJun 11, 2026Material Puncture/Hole

  IT WAS REPORTED THAT IMMEDIATELY AFTER PLACEMENT NATURAL SHEDDING OCCURRED ON FOLEY CATHETER JUST BEFORE SURGERY BEGAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25480171 ↗
• MalfunctionFeb 4, 2026Material Puncture/Hole

  IT WAS REPORTED THAT SEVERAL DAYS AFTER PLACEMENT THE FOLEY CATHETER HAD SPONTANEOUS DISLODGEMENT. IT WAS USED DURING OPERATION ON (B)(6) 2026, THURSDAY, AND CONFIRMED SPONTANEOUS DISLODGEMENT ON (B)(6) 2026, SATURDAY. THE LEAK LOCATION WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24264580 ↗
• MalfunctionJan 12, 2026Material Puncture/Hole

  IT WAS REPORTED THAT DURING THE OPERATION, A FOLEY CATHETER CUFF TEST WAS PERFORMED, AND THE CATHETER WAS INSERTED IN THE PATIENT. DURING SURGERY, AND NO URINE COULD BE CONFIRMED IN THE COLLECTION BAG, SO A CATHETER CHECK WAS PERFORMED, REVEALING LEAKAGE OF STERILE DISTILLED WATER FROM THE 2 WAY PORTION. ANOTHER 119316 CATHETER WAS INSERTED. THE FIRST ONE OCCURRED DURING SURGERY, BUT THE SECOND INSERTED PRODUCT WAS DEFECTIVE. WHILE BEING TRANSFERRED FROM THE OPERATING ROOM TO THE INTENSIVE CARE UNIT, LEAKAGE OF STERILE WATER FROM THE 2 WAY PORTION WAS NOTICED. HOWEVER, SINCE TWO BALLOONS WERE ALREADY INSERTED IN THE SAME PATIENT AND URETHRAL INJURY WAS A CONCERN, IT WAS MANAGED AS WAS IN THE INTENSIVE CARE UNIT. ON THE SAME DAY, IT DISLODGED, LEADING TO THE PRODUCT BEING RECALLED. THE PATIENT WAS MALE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24048931 ↗
• MalfunctionJan 12, 2026Material Puncture/Hole

  IT WAS REPORTED THAT DURING THE OPERATION, A FOLEY CATHETER CUFF TEST WAS PERFORMED, AND THE CATHETER WAS INSERTED IN THE PATIENT. DURING SURGERY, AND NO URINE COULD BE CONFIRMED IN THE COLLECTION BAG, SO A CATHETER CHECK WAS PERFORMED, REVEALING LEAKAGE OF STERILE DISTILLED WATER FROM THE 2-WAY PORTION. ANOTHER 119316 CATHETER WAS INSERTED. THE FIRST ONE OCCURRED DURING SURGERY, BUT THE SECOND INSERTED PRODUCT WAS DEFECTIVE. WHILE BEING TRANSFERRED FROM THE OPERATING ROOM TO THE INTENSIVE CARE UNIT, LEAKAGE OF STERILE WATER FROM THE 2-WAY PORTION WAS NOTICED. HOWEVER, SINCE TWO BALLOONS WERE ALREADY INSERTED IN THE SAME PATIENT AND URETHRAL INJURY WAS A CONCERN, IT WAS MANAGED AS WAS IN THE INTENSIVE CARE UNIT. ON THE SAME DAY, IT DISLODGED, LEADING TO THE PRODUCT BEING RECALLED. THE PATIENT WAS MALE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24048929 ↗
• MalfunctionDec 17, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT FOLEY CATHETER WAS SPONTANEOUSLY DISLODGED WHILE THE PATIENT WAS IN CUSTODY. THE STERILE WATER HAD LEAKED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23832820 ↗
• MalfunctionDec 11, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT CUSTOMER STATED THEY RECEIVED A KIT AND INSIDE THE KIT THE FOLEY CATHETER WAS DEFECTIVE. THE TEMPERATURE WIRE WAS OUTSIDE THE CATHETER. CUSTOMER HAS PRODUCT TO RETURN IF NEEDED. CUSTOMER WOULD LIKE REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23780463 ↗
• MalfunctionDec 4, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE CUSTOMER HAS RECENTLY EXPERIENCED ANOTHER INCIDENT INVOLVING A FOLEY CATHETER BALLOON DEFECT DURING SURGERY. AFTER THE PROCEDURE, THE SURGEON NOTED THAT THE FOLEY CATHETER HAD FALLEN OUT. UPON INSPECTION, IT WAS FOUND THAT THE BALLOON HAD RUPTURED, LEADING TO DEFLATION AND DISLODGEMENT OF THE CATHETER. A NEW FOLEY CATHETER WAS INSERTED WITHOUT FURTHER COMPLICATION. PER CUSTOMER FOLLOW UP INFORMATION RECEIVED VIA ATTACHMENT ON 25NOV2025, IT WAS REPORTED THAT THE FOLEY FELL OUT ON FLOOR, SO THEY DID NOT HAVE TO TROUBLESHOOT. FOLEY WAS PLACED BY SURGEON AT START OF CASE, AFTER CASE WAS COMPLETED, DRAPES REMOVED, THE FOLEY WAS NOTED TO HAVE BEEN DISLODGED AND FELL ON TO THE FLOOR. THE FOLEY BALLOON HAD BROKEN AND DID NOT APPEAR TO HAVE ANY FRAGMENTS -ALL RUBBER WAS STILL INTACT. SURGEON ONLY USED 10ML OF THE STERILE WATER FROM THE SYRINGE PROVIDED IN THE FOLEY KIT. NO PATIENT IMPACT AND MEDICAL INTERVENTION WAS REPORTED. FOLEY WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23717138 ↗
• MalfunctionDec 3, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON WAS DEFLATED AND THEY THOUGHT THAT POPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23708514 ↗
• MalfunctionNov 21, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DURING PLACEMENT THE FOLEY CATHETER STERILE WATER LEAKED FROM THE FUNNEL PART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23619456 ↗
• MalfunctionNov 21, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DURING PRETEST THE FOLEY CATHETER STERILE WATER LEAKED FROM THE FUNNEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23615920 ↗
• MalfunctionNov 11, 2025Material Puncture/Hole; Material Rupture; Material Puncture/Hole; Material Rupture

  IT WAS REPORTED THAT WHEN ATTEMPTED TO INSERT A FOLEY CATHETER IN THE OPERATING ROOM FOR URINARY CATHETERIZATION AND TEMPERATURE MANAGEMENT DURING THE PRE TEST. IT WAS REPORTED THAT STERILE WATER LEAKED FROM THE CUFF AND THE BALLOON RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23526434 ↗
• MalfunctionNov 4, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING USE FOLEY CATHETER WAS SPONTANEOUSLY REMOVED WHILE USING THE PRODUCT, DUE TO THE BALLOON PORTION WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23469675 ↗
• MalfunctionOct 10, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT DAY 3 OF PLACEMENT, FOLEY CATHETER WAS INSERTED ON AUGUST 1ST. NATURALLY REMOVED AROUND 7:00 PM ON AUGUST 3RD. THE BALLOON WAS DAMAGED. IT LEAKED FROM THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23266504 ↗
• MalfunctionOct 9, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING PRETESTING THE FOLEY CATHETER HAD DIFFICULTY IN DRAINING WATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23255051 ↗
• MalfunctionOct 7, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT AFTER INSERTION, THE FOLEY CATHETER STERILE WATER LEAKED, AND COULD NOT BE RETAINED. IT WAS FOUND THAT THE BALLOON RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23235190 ↗
• MalfunctionSep 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE FOLEYS WERE LEAKING AT THE CONNECTION OF THE BAG AND THE TUBING. NO PATIENT INJURY WAS REPORTED AND NO MEDICAL TREATMENT REQUIRED. PER ADDITIONAL INFORMATION RECEIVED ON 02OCT2025, IT WAS REPORTED THAT THE PHYSICAL SAMPLE IS AVAILABLE. LOT NGJP3330 WAS PROVIDED. PRODUCTS USED ON PATIENTS WERE THROWN AWAY AND REMAINING LOT NUMBERS WHERE PULLED. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23084158 ↗
• MalfunctionSep 2, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING PRETEST AFTER INFLATING THE FOLEY CATHETER BALLOON DURING THE BALLOON CHECK, WHEN DRAINING THE FLUID WITH A SYRINGE, THE BALLOON DID NOT SHRINK PROPERLY EVEN WHEN NEGATIVE PRESSURE WAS APPLIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22939698 ↗
• MalfunctionAug 26, 2025Material Rupture; Component Misassembled; Material Rupture; Component Misassembled

  IT WAS REPORTED THAT THERE WAS A BALLOON RUPTURE AFTER INSERTING A URINARY FOLEY CATHETER, URINE WAS FOUND TO BE LEAKING OUT FROM THE CONNECTION BETWEEN THE CATHETER AND THE BALLOON. AS THIS WAS NOT A TEMPORARY OCCURRENCE, THE CATHETER WAS REMOVED AND A NEW ONE WAS INSERTED, AND THE SURGERY PROCEEDED WITHOUT FURTHER ISSUES. PER ADDITIONAL INFORMATION RECEIVED VIA IBC ON 28UG2025, STATED THAT THE OVERVIEW OF THE EVENT WAS CHANGED TO URINE LEAKAGE FROM BALLOON BREAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22896623 ↗
• MalfunctionJul 28, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT FOLEY CATHETER BALLOON WAS NOT INFLATED DURING THE PRE-TEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22630085 ↗