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

Summary

The FDA's MAUDE database contains 231 adverse event reports that list this exact device (DI 00801741039911), received between Jul 17, 2017 and Sep 23, 2026 — classified as 11 injuries, 220 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (69 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 231 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Material Rupture

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

  MAUDE report 50873295 ↗
• MalfunctionSep 22, 2026Fluid/Blood Leak

  It was reported that the Temperature Sensing foley catheter, inflation port leaked sterile water after foley inserted and balloon inflated, unable to keep balloon inflated.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50855637 ↗
• InjurySep 21, 2026Patient Device Interaction Problem

  Patient problems: Burning Sensation

  MAUDE report 50848287 ↗
• MalfunctionSep 5, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50634111 ↗
• MalfunctionJul 28, 2026Fluid/Blood Leak

  It was reported by customer that there was a leak in the Foley Tubing.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50059469 ↗
• MalfunctionFeb 25, 2026Material Puncture/Hole

  IT WAS REPORTED THAT AFTER PROPER INSERTION AND URINE RETURN, THE FOLEY CATHETER WAS BEING INSTILLED WITH WATER FOR BALLOON INFLATION. THERE WAS A PINHOLE AT THE JUNCTION BETWEEN THE FOLEY TUBE AND THE Y CONNECTOR WHERE THE URINE COLLECTION BAG AND THE INFLATION PORT MET. THE FOLEY WAS REMOVED, A BRAND NEW KIT OPENED AND THE SECOND FOLEY WAS INSERTED WITHOUT INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24442668 ↗
• MalfunctionJan 28, 2026Material Rupture

  IT WAS REPORTED THE BALLOON RUPTURED ON TWO SEPARATE OCCASIONS WITH THE PATIENT. ONE WAS A TEMP SENSING FOLEY, AND THE OTHER WAS A SILICONE CATH WITH SILVER COATING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24206428 ↗
• MalfunctionJan 27, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WERE SOME PRODUCT FAILURES WITH FOLEY TRAYS RECENTLY. FOLEY CATHETERS WERE LEAKING. PER ADDITIONAL INFORMATION RECEIVED ON 13JAN2026, IT WAS REPORTED THAT THEY CONTINUE TO HAVE ISSUES WITH FOLEY CATHETER LEAKING. IT APPEARS TO BE THE SAME LOT (LOT NGKX0344). UNFORTUNATELY, THEY DO NOT HAVE ANY ACTUAL PRODUCT TO SEND BACK FOR EVALUATION, AND THE ISSUE APPEARS TO BE ISOLATED TO THEIR ICU. IF WE NEED ANY CLINICAL FEEDBACK THEY ASKED TO CONNECT WITH A REPRESENTATIVE. THEY DO NOT HAVE A CONSISTENT LOT NUMBER. THEY ALSO ASKED, HAS THE DESIGN CHANGED OR THE SIZE OF THE HOLES IN THE TIP. THEY ARE HAVING DIFFICULTY FINDING A CONSISTENT TREND OF PRODUCT BUT NOTING THIS ACROSS SEVERAL LOT NUMBERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24191188 ↗
• MalfunctionJan 26, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THEY CONTINUE TO HAVE ISSUES WITH FOLEY CATHETER LEAKING. IT APPEARS TO BE THE SAME LOT (LOT# NGKX0344). UNFORTUNATELY, THEY DO NOT HAVE ANY ACTUAL PRODUCT TO SEND BACK FOR EVALUATION, AND THE ISSUE APPEARS TO BE ISOLATED TO THEIR ICU. IF WE NEED ANY CLINICAL FEEDBACK THEY ASKED TO CONNECT WITH (B)(6). THEY DO NOT HAVE A CONSISTENT LOT NUMBER. THEY ALSO ASKED, HAS THE DESIGN CHANGED OR THE SIZE OF THE HOLES IN THE TIP. THEY ARE HAVING DIFFICULTY FINDING A CONSISTENT TREND OF PRODUCT BUT NOTING THIS ACROSS SEVERAL LOT NUMBERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24185308 ↗
• MalfunctionJan 16, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT THE REGISTERED NURSE PLACED FOLEY CATHETER, URINE LEAKED OUT OF THE TUBE AT BIFURCATION. RN REPLACED FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24093535 ↗
• MalfunctionDec 11, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THEY HAD ANOTHER ONE OF THESE FOLEY TRAYS TODAY REF# (B)(4) THAT DID NOT DEFLATE. THEY BELIEVE THIS IS LOT# PK7676940, THEY WERE SENT A PICTURE OF THE SHEET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23777934 ↗
• InjuryDec 9, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT WHILE REMOVING INDWELLING FOLEY CATHETER, THE WHITE WIRE INSIDE THE FOLEY TUBE THAT GOES IN URETHRA TO MONITOR TEMPERATURE (TYPICALLY IN THE ICU) WAS PROTRUDED THROUGH THE FOLEY TUBING. THERE WAS A MINOR ABRASION TO PATIENT'S URETHRAL EXIT SITE AS WELL AS BILATERAL INNER UPPER THIGHS FROM THE DAMAGE OF THIS AREA IN THE FOLEY. MEPILEX PLACED ON BILATERAL INNER THIGH REGIONS. CUSTOMER DID SAFE DEFECTIVE PRODUCT. PATIENT INFORMATION CANNOT BE PROVIDED.

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

  MAUDE report 23763756 ↗
• MalfunctionDec 3, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT WHEN FILLING THE BALLOON WATER STARTED LEAKING OUT BECAUSE OF A LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23707560 ↗
• MalfunctionNov 10, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE CUSTOMER HAD AN ISSUE REMOVING A FOLEY RECENTLY WHERE THE BALLOON COULD NOT BE DEFLATED APPROPRIATELY. THEY SAVED THE FOLEY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23509756 ↗
• MalfunctionNov 7, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE RN PLACED FOLEY CATHETER FOR A PATIENT UNDERGOING SPINAL SURGERY. AT THE END OF THE CASE WHEN THE TEAM FLIPPED THE PATIENT FROM THE PRONE TO SUPINE POSITION, THE FOLEY CAME OUT AND THE BALLOON WAS DEFLATED. THEY INSERTED A SYRINGE TO TRY AND INFLATE THE BALLOON TO SEE IF IT WAS DEFECTIVE. IT INFLATED, BUT THEN IMMEDIATELY DEFLATED. THERE WAS A HOLE NOTED IN THE BALLOON. NO KNOWN PATIENT HARM. PER FOLLOW UP INFORMATION RECEIVED ON 17DEC2025, NO IMPACT DUE TO THE DEVICE, NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23497742 ↗
• MalfunctionNov 7, 2025Material Puncture/Hole; Component Misassembled; Material Puncture/Hole; Component Misassembled

  IT WAS REPORTED FROM THE HOSPITAL USER HAS STATED AN ISSUE WITH A319516AM. NO KNOWN LOT NUMBER DUE TO THE PACKAGE CONTENTS BEING THROWN AWAY. NO KNOWN HARM TO THE PATIENT REPORTED. THE REGISTERED NURSE HAD PLACED THE FOLEY FOR A PATIENT WHO WAS HAVING SPINE SURGERY. AT THE END OF THE SURGERY WHEN THEY WENT TO FLIP THE PATIENT, THE FOLEY HAD COME OUT AND THE BALLOON WAS DEFLATED. THEY INSERTED A SYRINGE TO TRY AND INFLATE THE BALLOON TO SEE IF IT WAS DEFECTIVE. IT INFLATED, BUT THEN IMMEDIATELY DEFLATED. THERE WAS A HOLE IN THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23497152 ↗
• MalfunctionOct 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE FOLEY CATHETER WERE LEAKING FROM THE INSERTION SITE, AND THE PADS UNDERNEATH THE PATIENTS ARE SOAKED WITH URINE. IT HAS HAPPENED WITH MULTIPLE PATIENTS. ALSO, WHEN PLACING A NEW CATHETER AND INFLATING THE BALLOON AFTER GETTING URINE RETURN. CUSTOMER NOTICED URINE LEAKING AROUND PENIS FOR ONE OF THEIR PATIENTS. SEEMS THERE ARE DEFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23380769 ↗
• MalfunctionOct 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE FOLEY CATHETER WERE LEAKING FROM THE INSERTION SITE, AND THE PADS UNDERNEATH THE PATIENTS ARE SOAKED WITH URINE. IT HAS HAPPENED WITH MULTIPLE PATIENTS. ALSO, WHEN PLACING A NEW CATHETER AND INFLATING THE BALLOON AFTER GETTING URINE RETURN. CUSTOMER NOTICED URINE LEAKING AROUND PENIS FOR ONE OF THEIR PATIENTS. SEEMS THERE ARE DEFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23380756 ↗
• MalfunctionOct 20, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT HAD FOLEY CATHETER IN PLACE, WAS LEAKING REQUIRING REPLACEMENT. 2ND FOLEY LEAKING MORE THAN THE FIRST, AGAIN REPLACED. ADDITIONAL FOLEY IN SAME SIZE WAS OPENED. THE BALLOON NOT INFLATING ALL THE WAY AROUND THE CATHETER ALLOWING FOR URINE TO FLOW OUTSIDE OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23335678 ↗
• MalfunctionOct 20, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT HAD FOLEY CATHETER IN PLACE, WAS LEAKING REQUIRING REPLACEMENT. 2ND FOLEY LEAKING MORE THAN THE FIRST, AGAIN REPLACED. ADDITIONAL FOLEY IN SAME SIZE WAS OPENED. THE BALLOON NOT INFLATING ALL THE WAY AROUND THE CATHETER ALLOWING FOR URINE TO FLOW OUTSIDE OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23335676 ↗
• MalfunctionOct 15, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS INSERTED ON (B)(6) 2025 AT 1330 AND REMOVED (B)(6) 2025 AT 1530. THE EVENT REPORT AND GUIDANCE PROVIDED BY UROLOGY. THE FOLEY CATHETER DISCONTINUATION ENCOUNTERED RESISTANCE, WITH ONLY 10CC DRAINING FROM THE BALLOON. ATTEMPTS TO DEFLATE THE BALLOON WERE UNSUCCESSFUL. AFTER NO SUCCESS WITH REMOVAL, THE FOLEY WAS CUT TO FACILITATE FLUID EXPULSION, YIELDING MINIMAL DRAINAGE. FOLLOWING ROTATION AND STRIPPING OF THE LINE, THE CATHETER SLOWLY RELEASED AND ADVANCED. UPON FULL DISCONTINUATION, RESIDUAL FLUID WAS NOTED WITHIN THE BALLOON DURING INSPECTION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23300718 ↗
• MalfunctionOct 10, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THIS MORNING THE BALLOON OF THE FOLEY DEFLATED WHILE THE PATIENT WAS ALREADY POSITIONED IN THE PRONE POSITION. CUSTOMER HAD TO FLIP BACK TO THE GURNEY AND INSERT A NEW FOLEY. CUSTOMER TESTED THE REMOVED FOLEY BY INFLATING THE BALLOON AND IT TOOK ABOUT 35 MINUTES TO DEFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23271589 ↗
• MalfunctionOct 10, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOONS WITH HOLES IN THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23266310 ↗
• MalfunctionOct 10, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE CUSTOMER DESCRIBED LEAKING FROM A PINHOLE IN THE TEMPERATURE SENSING FOLEY CATHETER. FOLEY FELL OUT OF PATIENT. PER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 10DEC2025, IT WAS REPORTED THAT THE BARD REP ON SITE, SHERRY, TOOK THE FOLEY WITH HER. SHE HAS ALL LOT NUMBERS AND INFO. THE PATIENT HAD TO HAVE TWO DIFFERENT FOLEYS PLACED AFTER THE INCIDENT, AS THE INCIDENT HAPPENED TWICE. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23266002 ↗
• MalfunctionOct 8, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT HAD FOLEY CATHETER IN PLACE, WAS LEAKING REQUIRING REPLACEMENT. 2ND FOLEY LEAKING MORE THAN THE FIRST, AGAIN REPLACED. ADDITIONAL FOLEY IN SAME SIZE WAS OPENED. THE BALLOON NOT INFLATING ALL THE WAY AROUND THE CATHETER ALLOWING FOR URINE TO FLOW OUTSIDE OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23247058 ↗