Bardex All-Silicone Temperature-Sensing Foley CatheterRecalls & reported problems across all models

We found 3 models of Bardex All-Silicone Temperature-Sensing Foley Catheter by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 107 adverse event reports in the FDA's MAUDE database, received between Jun 20, 2017 and Sep 28, 2026 — classified as 107 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (28 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Bardex All-Silicone Temperature-Sensing Foley Catheter problems

Bardex All-Silicone Temperature-Sensing Foley Catheter models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Bardex® All-Silicone Temperature-Sensing Foley Catheter 119112

  CATHETER, RETENTION TYPE, BALLOON
  83 reports
• Bardex® All-Silicone Temperature-Sensing Foley Catheter 119116

  CATHETER, RETENTION TYPE, BALLOON
  20 reports
• Bardex® All-Silicone Temperature-Sensing Foley Catheter 119114

  CATHETER, RETENTION TYPE, BALLOON
  4 reports

Recent Bardex All-Silicone Temperature-Sensing Foley Catheter adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionMar 16, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OF THE FOLEY CATHETER DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24612392 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionSep 25, 2025Material Puncture/Hole; Material Split, Cut or Torn; Material Puncture/Hole; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING USE, FOLEY CATHETER LEAKED AT Y DOWN STRAIGHT. PATIENT WAS EXPOSED TO URINE. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Exposure to Body Fluids

  MAUDE report 23145090 ↗
• MalfunctionSep 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CLIENT COMPLAINED THAT JUST MINUTES AFTER INSTALLING THE FOLEY CATHETER WITH A TEMPERATURE SENSOR, IT BEGAN LEAKING URINE. IT WAS CONSIDERED BROKEN. THE CATHETER WAS REPLACED, AND THE PATIENT WAS ABLE TO CONTINUE THEIR NORMOTHERMIA THERAPY. PATIENT'S NORMOTHERMIA THERAPY WAS DELAYED AND INTERRUPTED FOR A FEW MINUTES.

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

  MAUDE report 23051336 ↗
• 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 ↗
• 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 ↗

Other C. R. Bard, Inc. products

• Bardex I.C. Foley Catheter26 models · 3,607 reports
• Bardex Lubricath Foley Catheter38 models · 1,670 reports · 1 recall
• Bardex Lubri-Sil I.C. All-Silicone Foley Catheter26 models · 1,518 reports
• Magic3 Coude Intermittent Catheter with Sure-Grip Sleeve5 models · 1,466 reports
• Magic3 Intermittent Catheter with Sure-Grip Sleeve14 models · 1,310 reports
• Bardia Foley Catheter Silicone Coated19 models · 1,283 reports
• PureWick Female External Catheter5 models · 1,184 reports
• Bardex All-Silicone Foley Catheter12 models · 1,170 reports