Bardex® Lubricath® Temperature-Sensing Foley Catheter 117416Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 00801741076930), received between Apr 26, 2017 and Jan 16, 2026 — classified as 16 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Partial Blockage” (13 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 58 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2026No Display/Image

  IT WAS REPORTED THAT THAT THE CLINICAL TEAM HAD RECEIVED APPROXIMATELY FOUR COMPLAINTS REGARDING ITEM A344916. THE TEMP SENSING FOLEY CATHETER WAS NOT DISPLAYING THE TEMP ON THE MONITOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24093539 ↗
• MalfunctionJun 30, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THAT CUSTOMER HAD ANOTHER FAILED SURESTEP FOLEY TRAY, THE TEMPERATURE PROBE WAS NOT SENSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22367189 ↗
• MalfunctionDec 4, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THEY WERE REACHING OUT BECAUSE THEY RECEIVED A SAFETY REPORT FROM CLINICAL STAFF REGARDING TEMPERATURE SENSING FOLEY CATHETER. THEY DID NOT HAVE A LOT NUMBER, AS THE PACKAGING WAS NOT SAVED. EVENT OCCURRED ON 24OCT2024. FOLEY CATHETER BALLOON WAS DEFECTIVE, THEY WERE UNABLE TO DEFLATE. THERE WAS NO TRAUMA OR INJURY TO PATIENT. TO THEIR KNOWLEDGE, THIS ISSUE HAS ONLY HAPPENED ONCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20844327 ↗
• MalfunctionFeb 20, 2024Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT FOLEY CATHETER WAS INSERTED WITHOUT DIFFICULTY, BUT NO URINE WAS RETURNED. BALLOON WAS NOT INFLATED. TRIED FLUSHING FOLEY CATHETER WITH STERILE SYRINGE AND FLUID BUT CATHETER WAS NOT FLUSHABLE. REMOVED CATHETER FROM PATIENT AND ATTEMPTED TO FLUSH CATHETER OUTSIDE OF PATIENT. CATHETER WAS PLUGGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18739006 ↗
• MalfunctionJan 30, 2024Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT TEMPERATURE SENSING FOLEY CATHETER BALLOON WOULD NOT INFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18605178 ↗
• MalfunctionJan 29, 2024Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT TEMPERATURE SENSING FOLEY CATHETER BALLOON WOULD NOT INFLATE (LOT#NGHU3052 AND LOT#NGHS3482).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18595360 ↗
• MalfunctionJan 24, 2024Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS INSERTED WITHOUT DIFFICULTY, BUT NO URINE WAS RETURNED. BALLOON WAS NOT INFLATED (PR# (B)(4) - LOT#NGHU3052, PR# (B)(4) - LOT# NGHS3482). TRIED FLUSHING FOLEY CATHETER WITH STERILE SYRINGE AND FLUID BUT CATHETER WAS NOT FLUSHABLE (PR# (B)(4) - LOT#NGHU3052, PR# (B)(4) - LOT#NGHS3482). REMOVED CATHETER FROM PATIENT AND ATTEMPTED TO FLUSH CATHETER OUTSIDE OF PATIENT. CATHETER WAS PLUGGED. (THIS HAPPENED A COUPLE WEEKS AGO IN THE OPERATING ROOM WITH THE EXACT SAME STYLE OF KIT THAT WAS ALSO SENT FROM OUR CENTRAL STORES ON OUR CASE CART). SINCE THIS WAS THE SECOND TIME IT HAD HAPPENED, AND BELIEVED THESE KITS NEED TO BE REMOVED FROM USE WITH THIS LOT#. IT COULD HARM THE PATIENT IF WE HAD TO KEEP REPLACING FOLEY CATHETERS. AND IF SOMEONE PUTS A CATHETER IN AND THINKS IT WENT IN FINE AND BLOWS UP THE BALLOON AND LEFT IT IN THE PATIENT, THERE COULD BE VERY SEVERE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18570748 ↗
• MalfunctionJan 24, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT DRAINAGE BAG ITSELF LEAKING, REPORTEDLY IN THE SEAM. RECENTLY THEY HAD OTHER TWO EVENTS ON TEMPERATURE SENSING FOLEY CATHETER THAT DO NOT DRAIN. TWO PATIENTS RECENTLY HAD TEMP SENSING FOLEYS PLACED THAT NEEDED TO BE REMOVED AND REPLACED SHORTLY AFTER PLACEMENT. WHEN NURSING FLUSHES THE CATHETER NOTHING COMES OUT OF THE TIP AND THE DRAINAGE HOLE SEEMS TO BE FAULTY. THE CATHETER THAT CUSTOMER HAD WAS ONE THAT NEEDED TO BE REPLACED. THE PATIENT THAT CAME IN LAST NIGHT CAME WITH A FOLEY FROM AN OUTSIDE FACILITY THAT WAS CHANGED TO A TEMP SENSING FOLEY HERE AT 6.45. THE PATIENT HAD NO URINE OUTPUT AT ALL AND FOLEY WAS IRRIGATED ONCE WITH NO RETURN, IV LASIX WAS GIVEN AROUND 7:30 PM WITH NO OUTPUT. THE FOLEY WAS REPLACED AROUND 1 AM AND THE PATIENT HAS HAD APPROXIMATELY 100 CC PER HR OUT SINCE THEN WITHOUT DIURETICS. NURSING TRIED TO IRRIGATE THE FOLEY THAT WAS REMOVED TO EVALUATE WHAT THE PROBLEM WAS, AND NOTHING CAME OUT OF THE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18570745 ↗
• MalfunctionJan 24, 2024Inability to Irrigate; Inability to Irrigate

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS INSERTED WITHOUT DIFFICULTY, BUT NO URINE WAS RETURNED. BALLOON WAS NOT INFLATED (PR# (B)(4) - LOT#NGHU3052, PR# (B)(4) - LOT# NGHS3482). TRIED FLUSHING FOLEY CATHETER WITH STERILE SYRINGE AND FLUID BUT CATHETER WAS NOT FLUSHABLE (PR# (B)(4) - LOT#NGHU3052, PR# (B)(4) - LOT#NGHS3482). REMOVED CATHETER FROM PATIENT AND ATTEMPTED TO FLUSH CATHETER OUTSIDE OF PATIENT. CATHETER WAS PLUGGED. (THIS HAPPENED A COUPLE WEEKS AGO IN THE OPERATING ROOM WITH THE EXACT SAME STYLE OF KIT THAT WAS ALSO SENT FROM OUR CENTRAL STORES ON OUR CASE CART). SINCE THIS WAS THE SECOND TIME IT HAD HAPPENED, AND BELIEVED THESE KITS NEED TO BE REMOVED FROM USE WITH THIS LOT#. IT COULD HARM THE PATIENT IF WE HAD TO KEEP REPLACING FOLEY CATHETERS. AND IF SOMEONE PUTS A CATHETER IN AND THINKS IT WENT IN FINE AND BLOWS UP THE BALLOON AND LEFT IT IN THE PATIENT, THERE COULD BE VERY SEVERE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18570412 ↗
• MalfunctionJan 24, 2024Inability to Irrigate; Inability to Irrigate

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS INSERTED WITHOUT DIFFICULTY, BUT NO URINE WAS RETURNED. BALLOON WAS NOT INFLATED (PR (B)(4) - LOT#NGHU3052, PR (B)(4) - LOT# NGHS3482. TRIED FLUSHING FOLEY CATHETER WITH STERILE SYRINGE AND FLUID BUT CATHETER WAS NOT FLUSHABLE (PR (B)(4) - LOT#NGHU3052, PR (B)(4) - LOT#NGHS3482). REMOVED CATHETER FROM PATIENT AND ATTEMPTED TO FLUSH CATHETER OUTSIDE OF PATIENT. CATHETER WAS PLUGGED. (THIS HAPPENED A COUPLE WEEKS AGO IN THE OPERATING ROOM WITH THE EXACT SAME STYLE OF KIT THAT WAS ALSO SENT FROM OUR CENTRAL STORES ON OUR CASE CART). SINCE THIS WAS THE SECOND TIME IT HAD HAPPENED, AND BELIEVED THESE KITS NEED TO BE REMOVED FROM USE WITH THIS LOT#. IT COULD HARM THE PATIENT IF WE HAD TO KEEP REPLACING FOLEY CATHETERS. AND IF SOMEONE PUTS A CATHETER IN AND THINKS IT WENT IN FINE AND BLOWS UP THE BALLOON AND LEFT IT IN THE PATIENT, THERE COULD BE VERY SEVERE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18570380 ↗
• MalfunctionJan 24, 2024Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS INSERTED WITHOUT DIFFICULTY, BUT NO URINE WAS RETURNED. BALLOON WAS NOT INFLATED (LOT#NGHU3052, LOT# NGHS3482). TRIED FLUSHING FOLEY CATHETER WITH STERILE SYRINGE AND FLUID BUT CATHETER WAS NOT FLUSHABLE (LOT#NGHU3052, LOT#NGHS3482). REMOVED CATHETER FROM PATIENT AND ATTEMPTED TO FLUSH CATHETER OUTSIDE OF PATIENT. CATHETER WAS PLUGGED. (THIS HAPPENED A COUPLE WEEKS AGO IN THE OPERATING ROOM WITH THE EXACT SAME STYLE OF KIT THAT WAS ALSO SENT FROM OUR CENTRAL STORES ON OUR CASE CART). SINCE THIS WAS THE SECOND TIME IT HAD HAPPENED, AND BELIEVED THESE KITS NEED TO BE REMOVED FROM USE WITH THIS LOT#. IT COULD HARM THE PATIENT IF WE HAD TO KEEP REPLACING FOLEY CATHETERS. AND IF SOMEONE PUTS A CATHETER IN AND THINKS IT WENT IN FINE AND BLOWS UP THE BALLOON AND LEFT IT IN THE PATIENT, THERE COULD BE VERY SEVERE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18569672 ↗
• MalfunctionJan 16, 2024Inaccurate Flow Rate; Inability to Irrigate; Inaccurate Flow Rate; Inability to Irrigate

  IT WAS REPORTED THAT DRAINAGE BAG ITSELF LEAKING, REPORTEDLY IN THE SEAM. RECENTLY THEY HAD OTHER TWO EVENTS ON TEMPERATURE SENSING FOLEY CATHETER THAT DO NOT DRAIN. TWO PATIENTS RECENTLY HAD TEMP SENSING FOLEYS PLACED THAT NEEDED TO BE REMOVED AND REPLACED SHORTLY AFTER PLACEMENT. WHEN NURSING FLUSHES THE CATHETER NOTHING COMES OUT OF THE TIP AND THE DRAINAGE HOLE SEEMS TO BE FAULTY. THE CATHETER THAT CUSTOMER HAD WAS ONE THAT NEEDED TO BE REPLACED. THE PATIENT THAT CAME IN LAST NIGHT CAME WITH A FOLEY FROM AN OUTSIDE FACILITY THAT WAS CHANGED TO A TEMP SENSING FOLEY HERE AT 6.45. THE PATIENT HAD NO URINE OUTPUT AT ALL AND FOLEY WAS IRRIGATED ONCE WITH NO RETURN, IV LASIX WAS GIVEN AROUND 7:30 PM WITH NO OUTPUT. THE FOLEY WAS REPLACED AROUND 1 AM AND THE PATIENT HAS HAD APPROXIMATELY 100 CC/HR OUT SINCE THEN WITHOUT DIURETICS. NURSING TRIED TO IRRIGATE THE FOLEY THAT WAS REMOVED TO EVALUATE WHAT THE PROBLEM WAS, AND NOTHING CAME OUT OF THE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18520176 ↗
• MalfunctionMay 5, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE CUSTOMER HAD ENCOUNTERED ISSUE WITH THE BALLOONS OF SILICONE INDWELLING CATHETERS LOSING FLUID AND DEFLATING EARLIER THIS WEEK. THE FOLEY CATHETER WAS PLACED ON (B)(6) 2023 IN SURGERY, AND IT WAS DOCUMENTED THAT THE BALLOON WAS INFLATED. HOWEVER, AT THE TIME OF CATHETER REMOVAL, THE BALLOON WAS FOUND TO BE COMPLETELY DEFLATED (LOT# NGGR3688). THIS WAS THE FIRST TIME THEY HAD HEARD OF THIS ISSUE, BUT THE REGISTERED NURSE ON THIS PATIENT CARE UNIT NOTED THIS MULTIPLE TIMES RECENTLY (LOT# UNK). ALTHOUGH THEY DID NOT HAVE ANY SPECIFICS OR THE CATHETER. THEY DID RE-INFLATE THE BALLOON YESTERDAY AND PLACED IT IN A BAG TO SAVE IT. TODAY, THERE WAS SOME FLUID IN THE BAG, WHICH WOULD INDICATE THE BALLOON WAS SLOWLY LEAKING. AS PER ADDITIONAL INFORMATION RECEIVED ON 15APR2023, IT WAS REPORTED THAT THE CUSTOMER WERE SHOWING THAT THEY HAD A TOTAL OF FOUR DIFFERENT FOLEYS IN THEIR OFFICE WAITING THAT THEY CAN RETURN FOR INVESTIGATION. THE 3 CATHETERS THAT SEEM TO HAVE AN ISSUE WITH DEFLATING BALLOONS, ONE FOLEY HAD SLIPPED OUT OF THE PATIENT, AND NURSE STATED THAT THEY TESTED THE BALLOON AND FELT A LEAK (LOT# NGFX5338) OTHER FOLEY (LOT# NGGX0360) AND AN OTHER FOLEY (LOT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16875539 ↗
• MalfunctionSep 16, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CUSTOMER MENTIONED ABOUT LEAKAGE, PAIN WHEN THEY WERE ASKED OF THE COMPLICATIONS WHILE USING THE TEMPERATURE SENSING FOLEY CATHETER. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15437548 ↗
• InjurySep 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUSTOMER MENTIONED ABOUT CATHETER BLOCKAGE, BLADDER FISTULA OR URETHRAL TRAUMA WHEN THEY WERE ASKED OF THE COMPLICATIONS WHILE USING THE TEMPERATURE SENSING FOLEY CATHETER. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR BLADDER FISTULA OR URETHRAL TRAUMA.

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

  MAUDE report 15437545 ↗
• MalfunctionSep 16, 2022Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE CUSTOMER MENTIONED CATHETER BLOCKAGE, BLADDER FISTULA OR URETHRAL TRAUMA WHEN THEY WERE ASKED OF THE COMPLICATIONS WHILE USING THE TEMPERATURE SENSING FOLEY CATHETER. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15437420 ↗
• MalfunctionSep 16, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CUSTOMER MENTIONED ABOUT LEAKAGE AND HEMATURIA WHEN THEY WERE ASKED OF THE COMPLICATIONS WHILE USING THE TEMPERATURE SENSING FOLEY CATHETER. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15437414 ↗
• MalfunctionSep 16, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CUSTOMER MENTIONED ABOUT LEAKAGE AND CATHETER BLOCKAGE WHEN THEY WERE ASKED OF THE COMPLICATIONS WHILE USING THE TEMPERATURE SENSING FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15437281 ↗
• MalfunctionSep 16, 2022Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE CUSTOMER MENTIONED ABOUT LEAKAGE AND CATHETER BLOCKAGE WHEN THEY WERE ASKED OF THE COMPLICATIONS WHILE USING THE TEMPERATURE SENSING FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15437279 ↗
• MalfunctionMay 6, 2022Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE CUSTOMER MENTIONED ABOUT CATHETER BLOCKAGE WHEN THEY WERE ASKED OF THE COMPLICATIONS WHILE USING THE TEMPERATURE SENSING FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14310975 ↗
• InjuryMay 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUSTOMER MENTIONED ABOUT BACTERIURIA, SYMPTOMATIC URINARY TRACT INFECTION WHEN THEY WERE ASKED OF THE COMPLICATIONS WHILE USING THE TEMPERATURE SENSING FOLEY CATHETER. MEDICAL INTERVENTION WAS UNKNOWN.

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

  MAUDE report 14310796 ↗
• InjuryApr 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURVEY RESPONDENT MENTIONED ABOUT BACTERIURIA, SYMPTOMATIC URINARY TRACT INFECTION , CATHETER BLOCKAGE , LEAKAGE WHEN THEY WERE ASKED OF THE COMPLICATIONS FACED WHILE USING THE TEMPERATURE SENSING FOLEY CATHETER. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

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

  MAUDE report 14254438 ↗
• InjuryApr 28, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE SURVEY RESPONDENT MENTIONED ABOUT CATHETER BLOCKAGE, PAIN, URETHRAL TRAUMA AND BLADDER TRAUMA WHEN ASKED ABOUT THE COMPLICATIONS WHILE USING THE TEMPERATURE SENSING FOLEY CATHETER. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

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

  MAUDE report 14240356 ↗
• MalfunctionApr 28, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CUSTOMER MENTIONED BACTERIURIA, PAIN, HEMATURIA AND LEAKAGE WHEN THEY WERE ASKED ABOUT THE COMPLICATIONS WHILE USING THE FOLEY CATHETER. MEDICAL INTERVENTION WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14240229 ↗
• MalfunctionApr 28, 2022Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE SURVEY RESPONDENT MENTIONED ABOUT CATHETER BLOCKAGE, PAIN, URETHRAL TRAUMA AND BLADDER TRAUMA WHEN THEY WERE ASKED OF THE COMPLICATIONS WHILE USING THE TEMPERATURE SENSING FOLEY CATHETER. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14240070 ↗