Bardex® I.C. Temperature Sensing Foley Catheter 129416MRecalls & reported problems

Summary

The FDA's MAUDE database contains 168 adverse event reports that list this exact device (DI 00801741039775), received between Jun 29, 2017 and Sep 17, 2026 — classified as 13 injuries, 155 malfunctions.

The most frequently reported specific device problem is “Erratic or Intermittent Display” (34 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 168 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Material Puncture/Hole

  It was reported that on (b)(6) 2026, a catheter was inserted for heart surgery. Upon leaving the operating room, urine output was confirmed, and the urine in the collection bag was discarded. In the evening, it was confirmed in the Intensive Care Unit (ICU) that there was no urine being produced. When the catheter was removed, the balloon was not inflated; assuming this might have made it difficult to locate the catheter, a fixed volume solution was infused. Since there was no urine produced afterward, the catheter was exchanged, resulting in the discharge of a large volume of urine mixed with blood. Urine output is currently confirmed to be normal.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50806116 ↗
• MalfunctionSep 17, 2026Material Puncture/Hole

  It was reported that the Foley catheter spontaneously dislodged a few days after placement in the EICU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50802946 ↗
• MalfunctionAug 27, 2026Material Puncture/Hole

  It was reported that during use the sterile water leaked from somewhere along the Foley catheter and the exact location was unknown.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50485335 ↗
• MalfunctionJul 14, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE URINE LEAKAGE AROUND FOLEY INSERTION SITE. FOLEY INSERTED FOR 5 DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25814316 ↗
• MalfunctionJul 14, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE URINE LEAKAGE AROUND FOLEY CATHETER INSERTION SITE. FOLEY WAS IN FOR 10 DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25811095 ↗
• MalfunctionJun 27, 2026Inflation Problem

  IT WAS REPORTED THAT FROM BURN UNIT, THEY HAD AN ISSUE WITH BARD FOLEY WITH TEMPERATURE PROBE. ONE PATIENT HAD A FLUID PORT WITH A RUBBER STOPPER, AND ANOTHER PATIENT HAD THE SAME FOLEY BUT WITH A BLUE LUER LOCK. THE RUBBER STOPPER PORT FOLEY WAS EXTREMELY HARD TO PUSH FLUID THROUGH. THIS ISSUE CREATED A DELAY IN OBTAINING ACCURATE BLADDER PRESSURE. UPON INVESTIGATION, IT WAS NOTED THAT THERE ARE TWO DIFFERENT TYPES OF SAMPLING PORTS. ONE IS A D Q-STYLE NEEDLE FREE SAMPLING PORT (LOT# NGLQ0565), AND THE OTHER IS A BD EZ-LOK NEEDLESS URINE SAMPLE PORT (LOT# NGLP1100). BOTH HAVE THE SAME REFERENCE NUMBER, A319416AM. THE EZ-LOCK IS THE BLUE LURE LOCK THAT PROVIDES ACCURATE AND EASY BLADDER PRESSURES, WHEREAS THE BD Q-STYLE HAS THE RUBBER PORT THAT BLOCKS THE USER'S ABILITY TO OBTAIN ACCURATE BLADDER PRESSURE READINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25646128 ↗
• MalfunctionMay 11, 2026Component Misassembled

  IT WAS REPORTED THAT THEY HAD SAW 3 OF THE ABOVE FOLEYS TRAYS THAT HAD ISSUES WITH THE FOLEY CATHETER ATTACHED TO THE TUBING IN THE TRAY. WHEN PULLING APART THAT WOULD STICK AND THEY WERE SAW HOLES IN THE FOLEY. PICS ATTACHED. STAFF STATED THAT THE FOLEY USED TO BE IN A BLUE PLASTIC SLEEVE AND THEY WOULD REMOVE THAT, NOW THAT WAS NOT AND THE FOLEY WAS UP NEXT TO THE TUBING. THE ONE IN THEIR OFFICE WAS NOT USED ON A PATIENT IT WAS OPENED IN THE ROOM AND IMMEDIATELY TAKE OUT UPON INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25144088 ↗
• MalfunctionApr 29, 2026Material Puncture/Hole

  IT WAS REPORTED THAT THE CUSTOMER STATED THEY HAD RECENTLY EXPERIENCED AN ISSUE IN WHICH THE BALLOON DEFLATED ON ITS OWN AND CAME OUT OF THE PATIENT. AFTER THE NURSE ATTEMPTED TO REINFLATE THE BALLOON TO CHECK FOR DAMAGE, THE BALLOON INITIALLY ACCEPTED AIR BUT THEN DEFLATED AGAIN ON ITS OWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25037679 ↗
• MalfunctionMar 10, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE TEMPERATURE SENSING FOLEY CATHETER WAS NOT DRAINING AND THE TIP OF THE CATHETER WAS DECOMPRESSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24563161 ↗
• MalfunctionFeb 13, 2026Disconnection

  IT WAS REPORTED THAT TWO FOLEY CATHETERS ON THE SAME UNIT EXPERIENCED SEPARATION OF THE TUBING FROM THE CONNECTION/PORT AREA. THE NURSE NOTED THE PATIENT¿S BED WAS WET AND OBSERVED THE TUBING WAS DETACHED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24338842 ↗
• MalfunctionFeb 12, 2026Failure to Infuse

  IT WAS REPORTED THAT DURING INSERTION THE FOLEY CATHETER HAD AN INCIDENT WHERE WATER INJECTION BECAME DIFFICULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24324832 ↗
• MalfunctionFeb 4, 2026Material Puncture/Hole

  IT WAS REPORTED THAT SURGERY HAD CAME ACROSS THIS DEFECTIVE FOLEY INSIDE OF A FOLEY TEMP SENSING TRAY. THE FOLEY HAD A HOLE IN IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24259543 ↗
• MalfunctionJan 23, 2026Disconnection

  IT WAS REPORTED THAT THE REGISTERED NURSE ATTEMPTED TO ASPIRATE URINE FROM THE SAMPLING PORT OF THE FOLEY CATHETER. UPON CONNECTING THE 10ML SYRINGE TO THE SAMPLING PORT, THE PORT'S COLLAR SEPARATED FROM THE DRAINAGE TUBE AND THE VALVE FELL OUT OF THE DEVICE, LEAVING AN OPEN HOLE IN THE DRAINAGE TUBE. THE FOLEY CATHETER WAS IMMEDIATELY REMOVED AND REPLACED WITH A NEW CATHETER. DEFECTIVE DEVICE AND LOOSE PARTS PRESERVED FOR INSPECTION, EQUIPMENT IN MANAGERS OFFICE. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24172895 ↗
• InjuryDec 12, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT TWO PATIENTS WHO HAD TEMP SENSING FOLEY CATHETER INSERTED WERE NOTED TO HAVE LITTLE TO NO URINE OUTPUT. THE REGISTERED NURSE SCANNED THE PATIENT'S BLADDER AND FOUND ONE WITH OVER 400CC OF URINE AND THE OTHER WITH OVER 300CC OF URINE AND NOTHING HAD COME THRU THE FOLEY.

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

  MAUDE report 23794077 ↗
• InjuryDec 12, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT TWO PATIENTS WHO HAD TEMP SENSING FOLEY CATHETER INSERTED WERE NOTED TO HAVE LITTLE TO NO URINE OUTPUT. THE REGISTERED NURSE SCANNED THE PATIENT'S BLADDER AND FOUND ONE WITH OVER 400CC OF URINE AND THE OTHER WITH OVER 300CC OF URINE AND NOTHING HAD COME THRU THE FOLEY.

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

  MAUDE report 23792499 ↗
• MalfunctionNov 13, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS INSERTED INTO THE PATIENT WITHOUT RESISTANCE OR DIFFICULTY. URINE WAS VISUALIZED IN THE TUBING, AND THE BALLOON WAS INFLATED WITH 10ML OF SALINE. THE CATHETER EASILY SLIPPED OUT OF THE PATIENT'S URETHRA. WHEN ASSESSING THE FOLEY, IT WAS NOTED THERE WAS A SMALL HOLE AT THE VERY TIP OF THE CATHETER WHERE THE FOLEY BALLOON WAS LOCATED. NEW FOLEY WAS INSERTED WITHOUT ADDITIONAL ISSUES. PER FOLLOW UP INFORMATION RECEIVED ON 03JAN2026, THE FOLEY HAD TO BE REPLACED. PHYSICAL SAMPLES ARE NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23544702 ↗
• MalfunctionNov 13, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE FOLEY CATHETER HAD LARGE TEAR ABOUT 1 CENTIMETER LONG WAS NOTED AT THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23542963 ↗
• MalfunctionOct 31, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE INDWELLING CATHETER WAS INSERTED BUT THEN THE BALLOON PORT MALFUNCTIONED AND DID NOT INFLATE CAUSING THE SALINE TO SPRAY ELSEWHERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23441791 ↗
• MalfunctionSep 30, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE TEMPERATURE SENSING CATHETER DID NOT READ A TEMPERATURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23178917 ↗
• MalfunctionSep 12, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THAT TEMPERATURE SENSING FOLEY CATHETER PLACED ON PATIENT AND TEMP CORD NOT WORKING. ATTEMPTED TO SWAP OUT BLACK TEMP CORD, BROWN TEMP CORD CONNECTOR, AND GE BRICK, WITHOUT SUCCESS. PER CUSTOMER FOLLOW UP RECEIVED VIA EMAIL ON 16SEP2025 STATED ATTEMPTED TO SWAP OUT BLACK TEMP CORD, BROWN TEMP CORD CONNECTOR, AND GE BRICK, WITHOUT SUCCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23038347 ↗
• MalfunctionSep 11, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING PRETESTING THE FOLEY CATHETER WATER DID NOT DRAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23027608 ↗
• MalfunctionJul 25, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THAT, TEMPERATURE WAS NOT DISPLAYED WHILE USING FOLEY CATHETER AND IT DID NOT DISPLAY EVEN WHEN A DIFFERENT RELAY CABLE WAS USED. THERE WAS NO COLLECTION OF SAMPLES DUE TO THE PATIENT BEING AN INFECTIOUS DISEASE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22607842 ↗
• MalfunctionJun 30, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT FOLEY CATHETER WOULD NOT DRAIN URINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22359959 ↗
• InjuryJun 23, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON HAD BURST AND WAS COMING OUT AND CHECKED IMMEDIATELY TO SEE IF THERE WERE ANY REMAINING PIECES. THERE WERE VISIBLE PIECES REMAINING.

  Patient problems: Foreign Body In Patient

  MAUDE report 22308651 ↗
• MalfunctionJun 18, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THERE WERE TWO PATIENTS ON THE 5TH FLOOR AND ONE IN TRAUMA INTENSIVE CARE UNIT THAT HAD BEEN FOUND WITH RUPTURED BALLOONS ON THEIR TEMPERATURE SENSING FOLEY CATHETERS. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 02JUN2025, IT WAS REPORTED THAT THE PATIENT RECEIVING GENTAMYCIN IRRIGATIONS 2 X DAILY WITH 1 HOUR DWELL TIME. PER REPORTING NURSE STATED THAT THE PATIENT COMPLAINED OF SUDDEN, SHARP PAIN AT FOLEY INSERTION SITE. AFTER ASSESSMENT, REPORTING NURSE FOUND FOLEY NEXT TO PATIENT WITH BALLOON NOT INTACT. IT WAS REPORTED THAT THE PATIENT WAS RECEIVING GENTAMYCIN IRRIGATIONS 2 X DAILY WITH 1 HOUR DWELL TIME. UPON REPORTING NURSE EVALUATION, IT WAS NOTED THAT THE PATIENT FOLEY WAS DISLODGED. AFTER FURTHER INVESTIGATION, IT WAS DETERMINED THAT THE BALLOON HAD RUPTURED. NO MEDICAL INTERVENTION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22284690 ↗