Bardex® All-Silicone Temperature-Sensing Pediatric Foley Catheter 119110Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00801741046001), received between Feb 9, 2018 and Aug 27, 2026 — classified as 2 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (5 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2026Material Puncture/Hole

  It was reported that after placement on a pediatric cardiology patient, the Foley catheter was found to have spontaneously dislodged. There was no fixation fluid, and although it had been secured with ample slack, it still dislodged spontaneously. The catheter was not placed for placement, and the patient was placed under observation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50485336 ↗
• MalfunctionDec 22, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT PRIOR TO SURGERY, NO URINE FLOW WAS OBSERVED WHEN THE FOLEY CATHETER WAS INSERTED. DURING THE SURGERY, THEY CONTINUED TO MONITOR BUT STILL DID NOT OBSERVE ANY URINE FLOW. UPON REMOVING THE CATHETER AND EXAMINING IT, THEY CONFIRMED AN OBSTRUCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23872351 ↗
• MalfunctionAug 27, 2025Inflation Problem; Material Puncture/Hole; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED THAT DURING A CUFF CHECK, ONLY SMALL AMOUNT OF WATER CAN BE PUMPED INTO THE FOLEY BALLOON, BUT ALMOST NO WATER CAN BE PUMPED IN, CAUSING THE WATER TO OVERFLOW FROM THE VALVE. THERE WAS A DIFFICULTY IN WATER INJECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22904074 ↗
• MalfunctionNov 24, 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 MONITORS 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 18204751 ↗
• MalfunctionAug 10, 2023Material Invagination; Material Invagination

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON WAS DEFORMED DURING THE PRETEST. PER PHOTO SAMPLE RECEIVED FROM IBC ON 01AUG2023, IT WAS NOTED THAT THAT TWO LOT NUMBERS HAD THIS ISSUE (BATCH# NGGP3275 AND BATCH# NGGV5075) PER FOLLOW-UP INFORMATION RECEIVED FROM IBC ON 02AUG2023, CLARIFIED THAT THE BALLOON WRINKLED WHEN THE BALLOON WAS DEFLATED DURING PRETEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17499371 ↗
• MalfunctionApr 25, 2023Partial Blockage; Inaccurate Flow Rate; Partial Blockage; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS UNABLE TO DRAIN URINE. FOLEY CATHETER WAS INSERTED FOR THE PURPOSE OF URINARY DRAINAGE DURING SURGERY. HOWEVER, FOLEY CATHETER WAS REMOVED BECAUSE THERE WAS NO URINE DRAINAGE AT ALL. FLUSHED SALINE SOLUTION INTO THE DRAINAGE LUMEN OF THE REMOVED FOLEY CATHETER, BUT SALINE SOLUTION COULD NOT BE DRAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16807872 ↗
• MalfunctionMar 30, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY CATHETER SPONTANEOUSLY FELL OUT OF THE PATIENT DUE TO WATER LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16642856 ↗
• MalfunctionJan 23, 2023Partial Blockage; Difficult to Remove; Partial Blockage; Difficult to Remove

  IT WAS REPORTED THAT THE LUMEN WAS OBSTRUCTED, AND NO OUTFLOW OF URINE COULD BE OBSERVED AFTER FOLEY CATHETER PLACEMENT. THE PLACEMENT OF THE CATHETER WAS CONFIRMED BY ECHOGRAPHY, AND THE TIP OF THE CATHETER WAS PLACED IN THE BLADDER. THE BALLOON WAS ALSO CONFIRMED TO BE INFLATED IN THE BLADDER. WHEN WATER WAS INJECTED THROUGH THE LUMEN, NO WATER ENTERED THE CATHETER, AND THE LUMEN WAS CONFIRMED TO HAVE BEEN OBSTRUCTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16223936 ↗
• MalfunctionSep 10, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AN EYELASH-LIKE SUBSTANCE WAS FOUND ON THE TIP OF THE FOLEY CATHETER BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12456630 ↗
• MalfunctionFeb 8, 2021Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT NO URINE FLOW WAS OBSERVED ON THE DAY OF USE DUE TO CATHETER BLOCKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11292249 ↗
• MalfunctionSep 30, 2020Deflation Problem; Material Invagination; Material Invagination

  IT WAS REPORTED THAT IT WAS DIFFICULT TO DEFLATE DUE TO THE BALLOON ROLL. AS PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 15 SEP 2020 FROM IBC REPRESENTATIVE, IT SEEMED THAT THERE WAS NO VISIBLE DEFECT ON THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10607186 ↗
• MalfunctionAug 12, 2020Leak/Splash; Material Puncture/Hole; Device Fell; Material Puncture/Hole

  IT WAS REPORTED THAT THE CATHETER FELL OUT. WHEN THE USER INFLATED THE CATHETER THAT HAD FALLEN OUT, THE CATHETER LEAKED AROUND THE VALVE. PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2020, WATER LEAKED FROM THE CATHETER AND SEEMED THAT THERE WAS NO VISIBLE DAMAGE TO THE CATHETER. THE CATHETER WAS REPLACED TO THE PATIENT DUE TO A LEAK FROM THE VALVE.

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

  MAUDE report 10396803 ↗
• MalfunctionSep 13, 2019Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT IT WAS DIFFICULT TO DEFLATE THE BALLOON DURING PRETEST.

  Patient problems: No Patient Involvement

  MAUDE report 9039093 ↗
• MalfunctionAug 21, 2019Crack; Deflation Problem; Fluid/Blood Leak; Deflation Problem

  IT WAS REPORTED THAT A WATER LEAK OCCURRED WHEN THE USER INJECTED WATER INTO THE INFLATION VALVE. THE WATER LEAKED FROM A CRACK ON THE CATHETER.

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

  MAUDE report 8917698 ↗
• MalfunctionJul 9, 2019Inaccurate Flow Rate; Inaccurate Flow Rate; No Flow

  IT WAS REPORTED THAT THERE WAS NO URINE FLOW AFTER THE CATHETER WAS INSERTED INTO THE PATIENT.

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

  MAUDE report 8773412 ↗
• MalfunctionMay 1, 2019Deflation Problem; Fluid/Blood Leak; Inflation Problem; Deflation Problem

  IT WAS REPORTED THAT IT WAS DIFFICULT TO INFLATE THE BALLOON OF THE CATHETER ALLEGEDLY DUE TO WATER LEAKAGE. IT WAS LATER REPORTED PER ADDITIONAL INFORMATION RECEIVED FROM THE IBC VIA EMAIL (B)(6)2019 ; THE EVENT OCCURRED DURING PRETEST.

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

  MAUDE report 8567965 ↗
• MalfunctionFeb 11, 2019Entrapment of Device; Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE THERMISTOR WIRE WAS SNAKED WITHIN THE LUMEN.

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

  MAUDE report 8329180 ↗
• MalfunctionDec 12, 2018Deflation Problem; Deflation Problem; Fluid/Blood Leak

  IT WAS REPORTED THAT WATER LEAKAGE OCCURRED FROM THE BALLOON DURING A PRETEST.

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

  MAUDE report 8155290 ↗
• MalfunctionDec 12, 2018Deflation Problem; Deflation Problem; Leak/Splash

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

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

  MAUDE report 8155113 ↗
• InjuryNov 30, 2018Material Invagination; Material Invagination; Material Deformation

  IT WAS REPORTED THAT THE 10FR TEMPERATURE SENSING FOLEY CATHETER BALLOON DEVELOPED A CUFF WHEN THE BALLOON WAS DEFLATED. THE PATIENT ALLEGEDLY EXPERIENCED PAIN AND WAS GIVEN LIDOCAINE BY THE NURSE. THE ROUTE OF DELIVERY WAS UNKNOWN.

  Patient problems: Pain

  MAUDE report 8120588 ↗
• MalfunctionMay 4, 2018Inaccurate Flow Rate; Inaccurate Flow Rate; Infusion or Flow Problem

  IT WAS REPORTED THAT URINE WAS NOT DRAINING THROUGH THE CATHETER.

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

  MAUDE report 7487756 ↗
• MalfunctionApr 6, 2018Mushroomed; Mushroomed; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THERE WAS A CUFF-ROLL ON THE BALLOON OF THE CATHETER. THE PATIENT EXPERIENCED SELF LIMITED PAIN.

  Patient problems: No Consequences Or Impact To Patient; Pain

  MAUDE report 7404508 ↗
• MalfunctionApr 6, 2018Mushroomed; Material Deformation; Mushroomed

  IT WAS REPORTED THAT THERE WAS A CUFF-ROLL ON THE BALLOON OF THE CATHETER. THE PATIENT EXPERIENCED SELF LIMITED PAIN.

  Patient problems: No Consequences Or Impact To Patient; Pain

  MAUDE report 7404507 ↗
• MalfunctionMar 19, 2018Restricted Flow rate; Inaccurate Flow Rate; Restricted Flow rate; Inaccurate Flow Rate; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THERE WAS NO DRAINAGE EYE ON THE CATHETER. THEN THE CATHETER WAS REMOVED AND REPLACED

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 7349097 ↗
• MalfunctionMar 6, 2018Inaccurate Flow Rate; Inaccurate Flow Rate; Device Operates Differently Than Expected; No Flow

  IT WAS REPORTED THAT THERE WAS NO DRAINAGE EYE ON THE CATHETER PRIOR TO USE.

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

  MAUDE report 7317455 ↗