Bardex® All-Silicone Temperature-Sensing Foley Catheter 119116Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00801741046032), received between Jun 20, 2017 and Jun 28, 2026 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (3 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 28, 2026Inaccurate Flow Rate

  IT WAS REPORTED THAT DURING USE OF THE FOLEY CATHETER BELOW INCIDENTS HAD HAPPENED, (1) DURING ICU CARE, THE PATIENT EXPERIENCED A PERIOD WITHOUT URINE DISCHARGE. EVEN AFTER ADJUSTING THE PATIENT'S POSTURE OR STRAIGHTENING THE CATHETER, URINE STILL COULD NOT BE SMOOTHLY DRAINED INTO THE URINE BAG. HOWEVER, THE PATIENT IMMEDIATELY FELT NOTICEABLE BLOATING, AND AFTER ABOUT 2 HOURS, A LARGE AMOUNT OF URINE WOULD FLOW OUT INSTANTLY, ABOUT 200 TO 300ML. (2) WHEN COLLECTING URINE SAMPLES, NURSES FOLLOW THE PROCEDURE BY FOLDING THE DRAINAGE CATHETER SO THAT THE SAMPLE CAN BE COLLECTED 30 MINUTES LATER. WHEN THE TIME COMES, THE NURSE EXTRACTS URINE FROM THE Y BRANCH OF THE URETER, ONLY AIR IS EXTRACTED, AND URINE CANNOT BE OBTAINED. HOWEVER, ONCE THE FOLD IS RELEASED, THE URINE FLOWS SMOOTHLY FROM THE CATHETER INTO THE URINE BAG. (3) NURSES IN GENERAL WARDS OBSERVE THAT EVEN WHEN THE CATHETER IS IN NORMAL USE, URINARY LEAKAGE STILL OCCURS. WHEN WITHDRAWING, THE WATER BALLOON IS DRAWN FIRST, BUT THE D AND W IS ONLY 3.5ML, WHICH DIFFERS FROM THE ORIGINAL D AND W OF 5ML INJECTED DURING CATHETERIZATION. THIS SITUATION IS NOT A SINGLE CASE; IT HAS OCCURRED REPEATEDLY IN MULTIPLE PATIENTS AND IS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25648334 ↗
• MalfunctionJun 26, 2026Fluid/Blood Leak

  It was reported that During use of the foley catheter below incidents had happened, (1) During ICU care, the patient experienced a period without urine discharge. Even after adjusting the patient's posture or straightening the catheter, urine still could not be smoothly drained into the urine bag. However, the patient immediately felt noticeable bloating, and after about 2 hours, a large amount of urine would flow out instantly, about 200-300ml. (2) When collecting urine samples, nurses follow the procedure by folding the drainage catheter so that the sample can be collected 30 minutes later. When the time comes, the nurse extracts urine from the Y-branch of the ureter, only air is extracted, and urine cannot be obtained. However, once the fold is released, the urine flows smoothly from the catheter into the urine bag. (3) Nurses in general wards observe that even when the catheter is in normal use, urinary leakage still occurs. When withdrawing, the water balloon is drawn first, but the D/W is only 3.5ml, which differs from the original D/W of 5ml injected during catheterization. This situation is not a single case; it has occurred repeatedly in multiple patients and is not limite

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25643276 ↗
• MalfunctionJun 26, 2026Difficult to Remove

  IT WAS REPORTED THAT DURING USE OF THE FOLEY CATHETER BELOW INCIDENTS HAD HAPPENED, (1) DURING ICU CARE, THE PATIENT EXPERIENCED A PERIOD WITHOUT URINE DISCHARGE. EVEN AFTER ADJUSTING THE PATIENT'S POSTURE OR STRAIGHTENING THE CATHETER, URINE STILL COULD NOT BE SMOOTHLY DRAINED INTO THE URINE BAG. HOWEVER, THE PATIENT IMMEDIATELY FELT NOTICEABLE BLOATING, AND AFTER ABOUT 2 HOURS, A LARGE AMOUNT OF URINE WOULD FLOW OUT INSTANTLY, ABOUT 200-300ML. (2) WHEN COLLECTING URINE SAMPLES, NURSES FOLLOW THE PROCEDURE BY FOLDING THE DRAINAGE CATHETER SO THAT THE SAMPLE CAN BE COLLECTED 30 MINUTES LATER. WHEN THE TIME COMES, THE NURSE EXTRACTS URINE FROM THE Y-BRANCH OF THE URETER, ONLY AIR IS EXTRACTED, AND URINE CANNOT BE OBTAINED. HOWEVER, ONCE THE FOLD IS RELEASED, THE URINE FLOWS SMOOTHLY FROM THE CATHETER INTO THE URINE BAG. (3) NURSES IN GENERAL WARDS OBSERVE THAT EVEN WHEN THE CATHETER IS IN NORMAL USE, URINARY LEAKAGE STILL OCCURS. WHEN WITHDRAWING, THE WATER BALLOON IS DRAWN FIRST, BUT THE D/W IS ONLY 3.5ML, WHICH DIFFERS FROM THE ORIGINAL D/W OF 5ML INJECTED DURING CATHETERIZATION. THIS SITUATION IS NOT A SINGLE CASE; IT HAS OCCURRED REPEATEDLY IN MULTIPLE PATIENTS AND IS NOT LIMITE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25643274 ↗
• MalfunctionJun 18, 2026Nonstandard Device; Use of Device Problem

  IT WAS REPORTED THAT DURING USE OF THE FOLEY CATHETER BELOW INCIDENTS HAD HAPPENED, (1) DURING ICU CARE, THE PATIENT EXPERIENCED A PERIOD WITHOUT URINE DISCHARGE. EVEN AFTER ADJUSTING THE PATIENT'S POSTURE OR STRAIGHTENING THE CATHETER, URINE STILL COULD NOT BE SMOOTHLY DRAINED INTO THE URINE BAG. HOWEVER, THE PATIENT IMMEDIATELY FELT NOTICEABLE BLOATING, AND AFTER ABOUT 2 HOURS, A LARGE AMOUNT OF URINE WOULD FLOW OUT INSTANTLY, ABOUT 200-300ML. (2) WHEN COLLECTING URINE SAMPLES, NURSES FOLLOW THE PROCEDURE BY FOLDING THE DRAINAGE CATHETER SO THAT THE SAMPLE CAN BE COLLECTED 30 MINUTES LATER. WHEN THE TIME COMES, THE NURSE EXTRACTS URINE FROM THE Y-BRANCH OF THE URETER, ONLY AIR IS EXTRACTED, AND URINE CANNOT BE OBTAINED. HOWEVER, ONCE THE FOLD IS RELEASED, THE URINE FLOWS SMOOTHLY FROM THE CATHETER INTO THE URINE BAG. (3) NURSES IN GENERAL WARDS OBSERVE THAT EVEN WHEN THE CATHETER IS IN NORMAL USE, URINARY LEAKAGE STILL OCCURS. WHEN WITHDRAWING, THE WATER BALLOON IS DRAWN FIRST, BUT THE D/W IS ONLY 3.5ML, WHICH DIFFERS FROM THE ORIGINAL D/W OF 5ML INJECTED DURING CATHETERIZATION. THIS SITUATION IS NOT A SINGLE CASE; IT HAS OCCURRED REPEATEDLY IN MULTIPLE PATIENTS AND IS NOT LIMITE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25552748 ↗
• MalfunctionJan 12, 2026Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT, AS SOON AS THE FOLEY CATHETER WAS CONNECTED, IT STARTED LEAKING FROM THE BI-DIRECTIONAL NECK JOINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24036701 ↗
• MalfunctionOct 17, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT AFTER MILKING, THE TEMPERATURE-SENSING WIRE BECOMES A COILED SHAPE OF THE FOLEY CATHETER WITHOUT LEAKAGE.

  Patient problems: Exposure to Body Fluids

  MAUDE report 23330578 ↗
• MalfunctionAug 26, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT LEAKAGE WAS NOTED DURING BALLOON INFLATION OF THE FOLEY CATHETER. THE ISSUE WAS RESOLVED AFTER REPLACING IT WITH A NEW CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22894692 ↗
• MalfunctionJul 14, 2025Material Fragmentation; Material Rupture; Material Fragmentation; Material Rupture

  IT WAS REPORTED THAT FOLEY CATHETER HAD LEAKAGE DUE TO CATHETER RUPTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22493981 ↗
• MalfunctionDec 28, 2023Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT FOLEY CATHETER COULD NOT DRAIN URINE AT THE 10TH DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18409539 ↗
• MalfunctionMar 15, 2023Inadequate Instructions for Healthcare Professional; Inadequate Instructions for Healthcare Professional

  IT WAS REPORTED THAT IN THE PACKAGING OF 119116 CATHETER, IT WAS MENTIONED AS SILICONE ELASTOMER FOLEY CATHETER. WHEN THE USER LOOKED AT THE PHOTO SAMPLE, THE USER THOUGHT IT WAS A 100 PERCENT SILICONE FOLEY CATHETER. THE USER ASKED TO CONFIRM WHICH ONE IT WAS SILICONE ELASTOMER OR 100 PERCENT SILICONE AND IT WAS CONFIRMED THAT 119116 WAS A BARDEX ALL-SILICONE TEMPERATURE-SENSING 400-SERIES FOLEY CATHETER. THE USER ASKED ABOUT FIXING THIS LABEL ON THE COVER OF 119116 AS THE SHAFT STATED IT WAS A 100% SILICONE ELASTOMER. THE USER WAS NOT SURE HOW SOME OUS LABELS DIFFER FROM US. THEY FOUND IT ODD THAT IT STATED LATEX-FREE AND SILICONE-ELASTOMER AND THOUGHT IT COULD HAD DIFFERENT MEANINGS IN DIFFERENT COUNTRIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16548204 ↗
• MalfunctionMar 15, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE FOLEY CATHETER HAD BEEN IN THE PATIENT FOR ONLY FEW HOURS, AND IT WAS NOTICED THAT THE TEMPERATURE CABLE INSIDE OF THE FOLEY WAS UNRAVELING AND DISTORTING THE CATHETER. THERE WAS NO TRAVELLING OR UNUSUAL MANIPULATION OF THE FOLEY WAS REPORTED. IT WAS REMOVED AND REPLACED, ALSO PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11490405 ↗
• MalfunctionAug 22, 2017Mushroomed

  IT WAS REPORTED THAT THE CATHETER HAD A MUSHROOM.

  Patient problems: No Information

  MAUDE report 6811895 ↗
• MalfunctionAug 22, 2017Kinked

  IT WAS REPORTED THAT THE CATHETER HAD A KNOT IN IT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6811894 ↗
• MalfunctionJul 18, 2017Leak/Splash

  IT WAS REPORTED THAT THE CATHETER LEAKED FROM AN UNKNOWN SOURCE. NO PATIENT INJURY WAS REPORTED. PER MEDWATCH: THE PLASTIC PORTION OF THE DRAINAGE BAG, WHERE IT CONNECTS TO THE UROMETER WAS LEAKING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6723918 ↗
• MalfunctionJul 11, 2017Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING THE SAMPLE INSPECTION, THERE WAS EXCESS SILICONE ON THE TIP OF THE CATHETER FOUND.

  Patient problems: No Patient Involvement

  MAUDE report 6700477 ↗
• MalfunctionJul 6, 2017Device Operates Differently Than Expected

  IT WAS REPORTED THAT, UPON INSPECTION OF THE SAMPLE RECEIVED, THERE APPEARED TO BE EXCESS SILICONE ON THE BIFURCATION VALVE BASE AND ON THE TIP OF THE CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6689350 ↗
• MalfunctionJul 5, 2017Mushroomed

  IT WAS REPORTED THAT THE BALLOON OF THE CATHETER HAD A MUSHROOM/RIDGE.

  Patient problems: No Information

  MAUDE report 6688672 ↗
• MalfunctionJun 27, 2017Product Quality Problem

  IT WAS REPORTED THAT THE TIP OF THE CATHETER AND THE INFLATION LUMEN AREAS APPEARED TO HAVE EXCESS SILICONE. THIS COMPLAINT WAS OPENED BECAUSE ASSOCIATE FA ENGINEER FOUND ISSUES OUTSIDE OF WHAT WAS ORIGINALLY REPORTED.

  Patient problems: No Information

  MAUDE report 6672506 ↗
• MalfunctionJun 21, 2017Overfill; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE CATHETER CONTAINED EXCESS SILICONE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6658969 ↗
• MalfunctionJun 20, 2017Overfill; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE CATHETER PORTION OF THE DEVICE CONTAINED EXCESS SILICONE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6654676 ↗