Bardex® All-Silicone Temperature-Sensing Pediatric Foley Catheter 119108Recalls & reported problems

Summary

The FDA's MAUDE database contains 76 adverse event reports that list this exact device (DI 00801741045998), received between Mar 31, 2017 and Mar 17, 2026 — classified as 76 malfunctions.

The most frequently reported specific device problem is “Partial Blockage” (18 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 76 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BEFORE USE, UPON CHECKING THE CATHETER BEFORE OPENING, HAIR CONTAMINATION WAS DISCOVERED, THE PRODUCT WAS NOT OPENED AND USE WAS WITHHELD, THE LOT NUMBER OF THE AFFECTED PRODUCT NGJY1504.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24616945 ↗
• MalfunctionJul 25, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING PRETEST THE BALLOON DID NOT INFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19826245 ↗
• MalfunctionNov 21, 2023Accessory Incompatible; Accessory Incompatible

  IT WAS REPORTED THAT THE BLACK CORDS THAT WERE WITHIN THE 8F AND 10F SURESTEP FOLEY TRAY SYSTEM WERE NOT COMPATIBLE WITH THE MONTIORS FOR TEMPERATURE MONITORING. THEY HAD CONFIRMED WITH CLINICAL ENGINEERING THAT THESE CORDS WERE NOT COMPATIBLE AND WOULD NOT WORK WITH THE DEVICES IN THE PEDS ED. THEY HAD ATTACHED PICTURES TO SHOW WHAT THE CONNECTOR NEEDED TO LOOK LIKE (WHITE CONNECTOR) THE OTHER WAS THE BLACK CORD THAT CAME WITH THE FOLEY KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18181250 ↗
• MalfunctionSep 29, 2023Material Puncture/Hole; Material Split, Cut or Torn; Material Puncture/Hole; Material Split, Cut or Torn

  IT WAS REPORTED THAT WHEN THE CATHETER WAS TESTED PRIOR TO INSERTION, THERE WAS NO BALLOON DEFLATION, BUT DURING THE PROCEDURE, THE CATHETER FELL OUT AND WHEN CHECKED, THERE WAS A HOLE. AS PER THE INVESTIGATOR NOTIFICATION RECEIVED ON 06JUN2023, THERE WAS DOUBLE PERFORATION OF THE NOTCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17845955 ↗
• MalfunctionSep 15, 2023Material Protrusion/Extrusion; Physical Resistance/Sticking; Material Protrusion/Extrusion; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE TEMPERATURE SENSING FOLEY CATHETER WAS STUCK TO THE INNER PACKAGING AND UPON REMOVAL DID STRETCH AND CAUSED THE TEMPERATURE PROBE TO ACCORDION IT SEEMS. THIS WAS NOT INSERTED INTO THE PATIENT, AND THEY WOULD CONTINUE TO MONITOR OTHER CATHETERS FOR SIMILAR ISSUES. PER FOLLOW UP VIA PHONE ON 31AUG2023,THE CUSTOMER STATED IT SEEMED THAT THERE WAS SOME STRETCHING OF THE CATHETER ON REMOVAL FROM THE STERILE PACKAGE AND THAT CAUSED A RELEASE OF THE TEMP PROBE FROM THE TIP AND CAUSED THE ¿ACCORDION¿ LIKE DISLODGEMENT OF THE TEMP SENSOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17755699 ↗
• MalfunctionJul 25, 2023Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT NO OUTFLOW OF URINE AFTER CATHETER INSERTION. WHEN THE CATHETER WAS REMOVED AND WATER WAS INJECTED, IT COULD NOT BE DRAINED. POSSIBLE BLOCKAGE AT THE TIP OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17389401 ↗
• MalfunctionJul 20, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT NO OUTFLOW OF URINE AFTER CATHETER INSERTION. WHEN THE CATHETER WAS REMOVED AND WATER WAS INJECTED, IT COULD NOT BE DRAINED. POSSIBLE BLOCKAGE AT THE TIP OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17365276 ↗
• MalfunctionMay 24, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT WATER COULD NOT BE REMOVED FROM THE BALLOON OF THE FOLEY CATHETER. UPON TRYING TO REMOVE THE CATHETER, THE CATHETER COULD NOT BE REMOVED BECAUSE A SPECIFIED AMOUNT OF STERILE DISTILLED WATER COULD NOT BE DRAINED. THEN THE CATHETER WAS CUT OFF AND WATER WAS DRAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16997038 ↗
• MalfunctionMay 11, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT WHEN THE CATHETER WAS TESTED PRIOR TO INSERTION, THERE WAS NO BALLOON DEFLATION, BUT DURING THE PROCEDURE, THE CATHETER FELL OUT AND WHEN CHECKED, THERE WAS A HOLE. AS PER THE INVESTIGATOR NOTIFICATION RECEIVED ON 06JUN2023, THERE WAS DOUBLE PERFORATION OF THE NOTCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16911727 ↗
• MalfunctionMar 7, 2023Material Puncture/Hole; Failure to Infuse; Material Puncture/Hole; Failure to Infuse

  IT WAS REPORTED THAT STERILIZED WATER LEAKED FROM AROUND THE BASE OF THE PART WHERE STERILE WATER WAS INJECTED. IT WAS INSERTED INTO THE URETHRAL OPENING ONCE BUT WAS REMOVED. PER FOLLOW-UP INFORMATION RECEIVED FROM IBC ON 01MAR2023 STATED THAT THE WATER LEAKED AFTER INSERTION AND THE BALLOON COULD NOT BE INFLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16495845 ↗
• MalfunctionJan 4, 2023Material Invagination; Material Invagination

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON WAS DIFFICULT TO REMOVE DUE TO THE DEFECTIVE BALLOON SHAPE. UPON ATTEMPTING TO REMOVE THE CATHETER AFTER PLACEMENT, WATER WAS DRAINED FROM THE BALLOON, BUT THERE WAS A RESISTANCE FELT. THEN AFTER THE BALLOON WAS INFLATED AGAIN, AND THE WATER WAS REMOVED. ALTHOUGH THERE WAS YET THE FEELING OF RESISTANCE, THE USER REMOVED THE CATHETER. WHEN THE CATHETER WAS CHECKED AFTER REMOVAL THE BALLOON PART WAS STEPPED, IF THERE WAS A STEP IN THE CUFF PART FOR CHILDREN, IT WOULD NOT COME OFF, SO IT WAS STRANGE AS A PRODUCT. IT HAD BECOME THICKER THAN 8FR. ALSO STATED THAT PATIENT HAD URETHRAL INJURY AND URINARY RETENTION. NO MEDICAL INTERVENTION WAS REPORTED. PER FOLLOW-UP INFORMATION RECEIVED VIA IBC ON 28DEC2022, STATED THAT THEY COULD NOT CONFIRM IF RETENTION OR URETHRAL INJURY WAS CAUSED BY FOLEY CATHETER. HOWEVER, THE USER SUSPECTS A CAUSAL RELATIONSHIP BETWEEN THEM. ALSO STATED THAT THE BALLOON PART WAS STEPPED. BUT THERE WERE NO OBVIOUS VISIBLE DEFECTS TO THE RETURNED SAMPLE.

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

  MAUDE report 16094241 ↗
• MalfunctionJun 20, 2022Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THERE WAS NO OUTFLOW OF URINE IN THE FOLEY CATHETER DURING THE OPERATION AND WHEN THE PASSAGE OF DISTILLED WATER WAS CONFIRMED WITH A SYRINGE AFTER REMOVAL, IT WAS OBSERVED THAT THE LUMEN OF THE FOLEY CATHETER WAS OBSTRUCTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14744645 ↗
• MalfunctionJun 14, 2022Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE WATER LEAKED FROM THE VALVE PART OF THE FOLEY CATHETER. THE DEVICE WAS NOT USED ON THE PATIENT. PER SAMPLE EVALUATION FROM THE INVESTIGATOR VIA EMAIL ON (B)(6) 2022, IT WAS REPORTED THAT SILICONE BLOCKAGE WAS FOUND IN THE DRAINAGE LUMEN OF THE FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14686821 ↗
• MalfunctionMay 19, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT NO URINE FLOWED AFTER THE PLACEMENT, THE TEMPERATURE SENSING CATHETER WAS CHANGED, AND WATER WAS TRIED TO INJECT FROM THE MAIN LUMEN, BUT IT WAS UNABLE TO DO . SINCE THE CATHETER WAS REPLACED DURING THE OPERATION, SOME OPERATIONS WERE HINDERED. PER FOLLOW UP INFORMATION RECEIVED ON 10NOV2021, CUSTOMER WOULD LIKE TO CONFIRM THE DRAINAGE RUMEN OBSTRUCTION AND TRIED TO INJECT FROM DRAINAGE RUMEN, BUT THEY COULD NOT. PER SAMPLE EVALUATION FROM THE INVESTIGATOR VIA EMAIL ON 27APR2022, THE TEMPERATURE SENSING WIRE WAS NOTED TO BE TANGLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14435480 ↗
• MalfunctionMay 16, 2022Material Invagination; Material Invagination

  IT WAS REPORTED THAT THE USER TRIED TO CHANGE THE CATHETER ON THE 4TH DAY OF USE, BUT FELT RESISTANCE WHEN USER PULLED IT OUT. THERE WAS BULGING AT THE BALLOON AREA AND NOT FLAT. THE FACILITY WANTS THE PRODUCT TO BE IMPROVED BECAUSE IT MAY CAUSE URETHRAL INJURY WHEN USED IN THE FUTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14407293 ↗
• MalfunctionApr 19, 2022Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE SENSICA DEVICE WAS NOT RECOGNIZING THE TEMPERATURE FOLEY CATHETER. IT WAS STATED THAT INITIALLY THE DEVICE SHOWED 35.3C AS A LOW TEMPERATURE AND 43.0C AS A HIGH TEMPERATURE, BUT LATER IT WAS ONLY SHOWING. THE USER WAS ABLE TO OBTAIN A CORD TO CONNECT THE FOLEY CATHETER WITH THE MONOPLUG ADAPTOR TO THEIR MONITOR INSTEAD. IT WAS STILL NOT DISPLAYING THE TEMPERATURE AND THERE WAS AN ALARM NOTIFICATION ¿TEMPERATURE OUT OF RANGE.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14142641 ↗
• MalfunctionMar 17, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS PLACED IN THE OPERATING ROOM AND IT RUPTURED IN THE WARD. THE USER NOTICED THAT THE CATHETER WAS TORN AND STERILE DISTILLED WATER WAS LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13796407 ↗
• MalfunctionFeb 22, 2022Difficult to Remove; Component Misassembled; Difficult to Remove; Component Misassembled

  IT WAS REPORTED THAT THE WATER DID NOT DRAIN FROM THE FOLEY CATHETER WHILE REMOVING. THE REMOVAL METHOD WAS UNKNOWN. PER FOLLOW UP VIA IBC ON 18FEB2022, THE PROCEDURE USED TO REMOVE AND REPLACE THE CATHETER WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13582007 ↗
• MalfunctionFeb 18, 2022Partial Blockage; Inaccurate Flow Rate; Partial Blockage; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE DRAINAGE EYE OF THE FOLEY CATHETER WAS OBSTRUCTED, AND THE URINE DID NOT FLOW AFTER CATHETER INSERTION. PER FOLLOW UP VIA IBC ON 01FEB2022, IT WAS UNKNOWN WHETHER THERE WAS A THE BLOCK IN THE CATHETER EYE OR ANY DAMAGE IN THE CATHETER AND PER FOLLOW UP VIA IBC ON 07FEB2022, THERE WAS NO VISIBLE DAMAGE OBSERVED IN THE RETURNED SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13563510 ↗
• MalfunctionDec 30, 2021Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE WATER LEAKED FROM THE VALVE PART OF FOLEY CATHETER. THE DEVICE WAS NOT USED ON THE PATIENT. PER SAMPLE EVALUATION FROM THE INVESTIGATOR VIA EMAIL ON 25MAY2022, IT WAS REPORTED THAT SILICONE BLOCKAGE WAS FOUND IN THE DRAINAGE LUMEN OF THE FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13119444 ↗
• MalfunctionDec 30, 2021Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT WATER LEAKED FROM THE VALVE AREA OF THE FOLEY CATHETER DURING THE PRETEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13119432 ↗
• MalfunctionDec 20, 2021Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT DURING A PRETEST, THE CATHETER BALLOON WAS DIFFICULT TO INFLATE. PER FOLLOW-UP INFORMATION RECEIVED VIA IBC ON 13DEC2021, STATED THAT THERE WAS NO DAMAGE IN THE BALLOON AND THE CATHETER WAS NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13049229 ↗
• MalfunctionNov 29, 2021Partial Blockage; Inaccurate Flow Rate; Partial Blockage; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE ALL-SILICONE TEMPERATURE SENSING FOLEY CATHETER WAS REMOVED AND WATER WAS INJECTED SINCE THERE WAS NO URINE FLOW, BUT THE SITUATION DID NOT CHANGE. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM IBC ON (B)(6) 2021, IT WAS CONFIRMED THAT THE BLOCKAGE IN THE CATHETER WAS UNKNOWN AND THERE WAS NO URINE FLOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12882664 ↗
• MalfunctionNov 23, 2021Inaccurate Flow Rate; Component Misassembled; Inaccurate Flow Rate; Component Misassembled

  IT WAS REPORTED THAT NO URINE FLOWED AFTER THE PLACEMENT AND THE TEMPERATURE SENSING CATHETER WAS CHANGED. WATER WAS TRIED TO INJECT FROM THE MAIN LUMEN, BUT IT WAS UNABLE TO DO. SINCE THE CATHETER WAS REPLACED DURING THE OPERATION SOME OPERATIONS WERE HINDERED. PER FOLLOW UP INFORMATION RECEIVED ON 10NOV2021, CUSTOMER WOULD LIKE TO CONFIRM THE DRAINAGE LUMEN OBSTRUCTION AND TRIED TO INJECT FROM DRAINAGE LUMEN, BUT THEY COULD NOT. PER SAMPLE EVALUATION FROM THE INVESTIGATOR VIA EMAIL ON 27APR2022, THE TEMPERATURE SENSING WIRE WAS NOTED TO BE TANGLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12859864 ↗
• MalfunctionNov 10, 2021Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS OCCLUDED AND IT COULD NOT DRAIN URINE. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON (B)(6) 2021, NO PATIENT IMPACT. IT WAS UNKNOWN WHETHER THERE WAS ANY SUBSTANCE WHICH BLOCKED THE URINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12788089 ↗