Bardex® All-Silicone Temperature-Sensing Foley Catheter 119112Recalls & reported problems

Summary

The FDA's MAUDE database contains 83 adverse event reports that list this exact device (DI 00801741046018), received between Nov 14, 2017 and Sep 28, 2026 — classified as 83 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (27 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 83 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924429 ↗
• MalfunctionMar 31, 2026No Display/Image

  IT WAS REPORTED THAT DURING USE OF THE FOLEY CATHETER, HEALTH PROFESSIONAL COULDN'T MEASURE THE BLADDER TEMPERATURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24749090 ↗
• MalfunctionDec 19, 2025Material Invagination; Difficult to Remove; Material Invagination; Difficult to Remove

  IT WAS REPORTED THAT WHILE THE STERILE WATER COULD BE DRAINED FROM THE FOLEY CATHETER DURING REMOVAL, THE CATHETER ITSELF WAS DIFFICULT TO REMOVE FROM THE PATIENT. THE PATIENT SUFFERS FROM BENIGN PROSTATIC HYPERPLASIA. POSSIBLE CAUSES INCLUDE CUFF ROLLING DURING DRAINAGE OR KINKING OF THE CATHETER TIP. A REQUEST WAS MADE TO IDENTIFY THE CAUSE OF THE DIFFICULTY IN REMOVAL. HX- PROSTATIC HYPERPLASIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850890 ↗
• MalfunctionJun 12, 2025Material Puncture/Hole; Material Rupture; Material Puncture/Hole; Material Rupture

  IT WAS REPORTED THAT WHEN CUSTOMER PERFORMED A PRETEST BEFORE PLACEMENT ON AN OUTPATIENT, THEY DISCOVERED THE FOLEY CATHETER BALLOON HAD BEEN DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22193768 ↗
• MalfunctionFeb 25, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE FOLEY CATHETER DURING RETENTION, TRIED TO RETAIN IT BUT NO URINE FLOWED. IT WAS PROBABLY CLOGGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21459281 ↗
• MalfunctionMar 21, 2024Decrease in Pressure; Material Puncture/Hole; Decrease in Pressure; Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY CATHETER SPONTANEOUSLY REMOVED DURING PLACEMENT. PER ADDITIONAL INFORMATION VIA EMAIL FROM IBC ON 08MAR2024, IT WAS UNKNOWN WHETHER ANY HOLE OR DAMAGE IN THE BALLOON. THE DEVICE USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18948966 ↗
• MalfunctionJun 23, 2023Decrease in Pressure; Material Puncture/Hole; Decrease in Pressure; Material Puncture/Hole

  IT WAS REPORTED THAT THE CATHETER SPONTANEOUSLY FELL OUT OF THE PATIENT AFTER TWO DAYS OF INDWELLING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17190356 ↗
• MalfunctionMay 1, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT WATER WAS DIFFICULT TO REMOVED FROM THE FOLEY CATHETER DURING THE PRETEST. THE CATHETER WAS NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16844311 ↗
• MalfunctionDec 28, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE WATER COULD BE DRAINED ONLY HALFWAY WHEN THE USER TRIED TO REMOVE THE WATER FROM THE FOLEY CATHETER DURING THE PRETEST. ABOUT 2 ML OF WATER WAS ASPIRATED BY SYRINGE. IT WAS STATED THAT THE USER TRIED TO DEFLATE USING SYRINGE BUT THE BALLOON WAS PARTIALLY DEFLATED AND THE CATHETER COULD BE REMOVED.COMPLETELY. USUALLY, BALLOON CAN BE DEFLATED WITHIN A FEW SECONDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16060966 ↗
• MalfunctionNov 28, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT FOLEY CATHETER BALLOON WAS DIFFICULT TO DEFLATE DURING PRETEST. THE WATER WAS DRAINED OUT OVER TIME. ACCORDING TO THE INQUIRY SHEET IT STATED THE BALLOON WAS PARTIALLY DEFLATED, BUT THE CATHETER COULD BE REMOVED. ALSO STATED THAT THE BALLOON WAS TRIED TO BE DEFLATED BY SPONTANEOUS OR GENTLE DEFLATION AND ASPIRATED BY SYRINGE MANUALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15868407 ↗
• MalfunctionNov 9, 2022Difficult to Remove; Difficult to Remove

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15758716 ↗
• MalfunctionSep 8, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY CATHETER FELL OUT AND THERE WAS NO WATER IN THE BALLOON ON THE DAY OF USE. IT WAS STATED THAT THE EVENT HAPPENED FEW HOURS AFTER PLACEMENT AND THERE WAS NO RUPTURE OR TEAR IN THE BALLOON. IT WAS UNKNOWN WHERE THE WATER LEAKED FROM BECAUSE THE EVENT WAS CATHETER FELL OUT. NO MATERIALS WERE IN CONTACT WITH THE CATHETER AND THE CATHETER WAS INSERTED BY HAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15378607 ↗
• MalfunctionJun 17, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON COULD NOT BE INFLATED AS THE STERILIZED WATER WAS INJECTED, DUE TO WATER LEAKAGE FROM AN UNKNOWN PART OF THE CATHETER. PER FOLLOW-UP INFORMATION RECEIVED FROM IBC ON 06DEC2021, STATED THAT THE CATHETER FELL OUT BECAUSE BALLOON DID NOT INFLATE. PER SAMPLE EVALUATION RESULTS RECEIVED ON 27MAY2022, IT WAS REPORTED THAT THE INFLATION NOTCH ON THE FOLEY CATHETER WAS FOUND TO BE TOO SMALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14732618 ↗
• MalfunctionJun 3, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE WATER IN THE FOLEY CATHETER BALLOON WAS DIFFICULT TO DEFLATE DURING PRETEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14593036 ↗
• MalfunctionApr 25, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE WATER DID NOT COME OUT FROM THE FOLEY CATHETER BALLOON DURING PRETEST. PER FOLLOW-UP INFORMATION RECEIVED VIA IBC ON (B)(6) 2022, STATED THAT IT WAS DIFFICULT TO DEFLATE THE FOLEY CATHETER BALLOON AND THE DAMAGE IN THE BALLOON WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14193548 ↗
• MalfunctionFeb 16, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT IT WAS DIFFICULT TO REMOVE THE WATER FROM FOLEY CATHETER DURING THE PRETEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13541444 ↗
• MalfunctionDec 20, 2021Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON COULD NOT BE INFLATED WHEN THE STERILIZED WATER WAS INJECTED, DUE TO WATER LEAKAGE FROM AN UNKNOWN PART OF THE CATHETER. PER FOLLOW-UP INFORMATION RECEIVED FROM IBC ON (B)(6) 2021, STATED THAT THE CATHETER FELL OUT BECAUSE BALLOON DID NOT INFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13043973 ↗
• MalfunctionDec 16, 2021Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON COULD NOT BE INFLATED WHEN THE STERILIZED WATER WAS INJECTED, DUE TO WATER LEAKAGE FROM AN UNKNOWN PART OF THE CATHETER. PER FOLLOW-UP INFORMATION RECEIVED FROM IBC ON 06DEC2021, STATED THAT THAT THE CATHETER FELL OUT BECAUSE BALLOON DID NOT INFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13018004 ↗
• MalfunctionDec 12, 2021Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT THE TEMPERATURE WAS NOT CORRECTLY DISPLACED. THE TEMPERATURE DISPLAY FAILURE OF THE SENSOR CATHETER STARTED INCREASING ON (B)(6) 2021. PER FOLLOW UP INFORMATION RECEIVED ON 01-DEC-2021, IT WAS REPORTED THAT THE CUSTOMER COMPLAINED THAT FROM (B)(6) THERE HAD BEEN ABOUT ONE CASE PER DAY TOTAL TO 30 CASES OF TEMPERATURE DISPLAY FAILURE. THERE ALLEGEDLY WERE CASES THAT THE TEMPERATURE DISPLAY WAS UNSTABLE IMMEDIATELY AFTER INSERTION, OR THAT THE TEMPERATURE WAS NOT DISPLAYED AFTER 10 MINUTES. PER FOLLOW UP INFORMATION RECEIVED ON 01-DEC-2021, IT WAS REPORTED THAT THE CUSTOMER COMPLAINED THAT THE CATHETER WAS DEFECTIVE BECAUSE THE MONITOR AND THE RELAY CABLE WERE CHECKED AND FOUND TO HAVE NO PROBLEMS. THE RELAY CABLE HAD NO PROBLEM WHEN USED IN OTHER CASES. THE PERSON IN CHARGE POINTED OUT THAT THE STRUCTURE OF THE CONNECTION PART OF THE CATHETER MIGHT BE LOOSE AND THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12981748 ↗
• MalfunctionDec 7, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS DIFFICULT TO DEFLATE DURING PRETEST. IT WAS ALSO STATED THAT THE BALLOON INFLATED ASYMMETRICALLY DURING PRETEST AND THEREFORE IT WAS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12955546 ↗
• MalfunctionDec 2, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON WAS DIFFICULT TO DEFLATE AND THE FOLEY CATHETER BALLOON INFLATED ASYMMETRICALLY DURING THE PRETEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12918878 ↗
• MalfunctionNov 30, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT ON THE NEXT DAY AFTER PLACEMENT, THE FOLEY CATHETER FELL OUT DUE TO BALLOON RUPTURE. ON (B)(6) 2021, THE CATHETER WAS PLACED DURING THE BREAST SURGERY. IN THE MIDNIGHT OF THE NEXT DAY, THE CATHETER FELL OUT OF THE PATIENT WITH NO WATER INSIDE THE BALLOON WHEN MOVING TO THE TOILET IN A WHEELCHAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12891778 ↗
• MalfunctionNov 10, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE CATHETER FELL OUT DUE TO WATER LEAKAGE. PER SAMPLE EVALUATION, THE TEMP SENSING WIRE WAS FOUND TO BE UNCOILING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12787762 ↗
• MalfunctionOct 13, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT RIGHT THIGH WAS WET, AND IT WAS CONFIRMED THAT THE WATER LEAKED FROM THE CATHETER BALLOON AFTER 1 HOUR OF PLACEMENT. IT WAS STATED THAT WHEN CHECKED, THE PRODUCT AND THE TEMPERATURE SENSOR SEEMED TO BE EXPOSED AND ONLY 1 CC OF WATER WAS REMAINING IN THE BALLOON. PER SAMPLE EVALUATION ON 27SEP2021, IT WAS STATED THAT THE TEMPERATURE SENSING WIRE WAS FOUND TO BE SNACKING. PER FOLLOW-UP INFORMATION RECEIVED VIA IBC ON (B)(6) 2021, STATED THAT THE WIRE WAS SNACKING MEANT THAT THE WIRE WAS TWISTED OR TANGLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12627160 ↗
• MalfunctionSep 27, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE FOLEY CATHETER FUNNEL HAD BEEN DIRTY BEFORE OPENING THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12533560 ↗