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

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741039799), received between Oct 5, 2017 and Jan 9, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Erratic or Intermittent Display” (2 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2026Material Rupture

  IT WAS REPORTED THAT THE BEDSIDE REGISTERED NURSE HAD NOTICED THE URINARY CATHETER LYING IN THE BED BETWEEN THE PATIENT'S LEGS. THERE WAS NO EVIDENCE OF MEATAL TRAUMA, AND THE PATIENT HAD NOT PULLED THE CATHETER OUT. THE RETENTION BALLOON WAS TORN. THE PROVIDER WAS NOTIFIED, AND THE CATHETER WAS NOT REPLACED. THIS EVENT HAD OCCURRED ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24031312 ↗
• 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. 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# N

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16882192 ↗
• MalfunctionApr 1, 2022Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT THERE WAS A TEMPERATURE FLUCTUATIONS AND INACCURACY ISSUES WHILE CONNECTED TO SENSICA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13978558 ↗
• MalfunctionMar 8, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE SAMPLE PORT OF THE TEMPERATURE SENSING FOLEY CATHETER WAS CRACKED AND HAD TO REPLACE FOLEY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13694104 ↗
• MalfunctionFeb 28, 2022Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT THE TEMPERATURE STEADILY CLIMBED FROM 37C TO 41C IN THE SENSICA DEVICE OVER A FEW HOURS WHILE USING THE TEMPERATURE SENSING FOLEY CATHETER. NURSE STATED THAT THE AXILLARY AND ORAL TEMPERATURE DID NOT RISE. THE NURSE SWITCHED OUT THE SENSICA UNIT AND TEMPERATURE CABLES AND STILL SAW A SIMILAR 41C READING. LATER THE PATIENT NEEDED TO GO TO SURGERY SO BOTH SENSICA UNITS WERE GIVEN TO THE ONSITE TEAM AND TESTED WITH TEMPERATURE KEYS, AND EACH READ THE TEMPERATURE KEYS CORRECTLY. THE NURSE PUT THE PATIENT ON A THIRD SENSICA SYSTEM AND STILL READ 41C AFTER SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13619479 ↗
• InjuryMar 4, 2019Deflation Problem

  IT WAS REPORTED THAT THE BALLOON OF THE BARDEX IC TEMP SENSING FOLEY CATHETER WOULD NOT DEFLATE. AN ULTRASOUND WAS REQUIRED TO HELP GUIDE AN 18G SPINAL NEEDLE THROUGH THE PERINEUM TO POP THE BALLOON.

  Patient problems: No Information; Patient Problem/Medical Problem

  MAUDE report 8388901 ↗
• MalfunctionJun 28, 2018Material Too Rigid or Stiff; Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE CATHETER HAD A ROUGH SURFACE.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 7647973 ↗
• MalfunctionOct 5, 2017Leak/Splash

  IT WAS REPORTED THAT THE CATHETER LEAKED FROM AN UNKNOWN LOCATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6917872 ↗