Bardex® I.C. Foley Catheter 0165SI14Recalls & reported problems
C. R. Bard, Inc. · Bardex® I.C. 5cc/mL Balloon Foley Catheter · Class 2
All models of Bardex I.C. Foley Catheter (26)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Bard Bardex I.C. Foley catheter is a urinary catheter with a balloon that holds it in the bladder. Many reports describe the balloon not filling or deflating, fluid leaks, and holes in the tube. The records include 1,962 reports, 115 injuries and no deaths, and no recalls name this device. Reports fell from 349 in the year before to 82 in the most recent year.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 1,994
- Deaths reported
- 0
- Injuries reported
- 116
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,994 adverse event reports that list this exact device (DI 00801741016745), received between Mar 28, 2017 and Sep 30, 2026 — classified as 116 injuries, 1,878 malfunctions.
The most frequently reported specific device problem is “Failure to Infuse” (341 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.
Reports received per month
Most reported problems
Device problems
- Failure to Infuse341
- Fluid/Blood Leak314
- Material Puncture/Hole297
- Deflation Problem270
- Burst Container or Vessel234
- Decrease in Pressure220
- Material Rupture172
- Inflation Problem156
Patient problems
- No Clinical Signs, Symptoms or Conditions1,371
- No Known Impact Or Consequence To Patient386
- No Consequences Or Impact To Patient315
- No Patient Involvement180
- Foreign Body In Patient76
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available45
- Patient Problem/Medical Problem24
- No Code Available13
Recent adverse event reports
The 25 most recent of 1,994 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Fluid/Blood Leak
It was reported that Urine leaks from the space between the catheter and the urethra.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950581 ↗MalfunctionSep 29, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940871 ↗InjurySep 21, 2026Difficult to Remove
It was reported that during the catheter exchange, health professional confirmed that approximately 8 mL of retained fluid had been drained and attempted to remove the Foley catheter; however, it did not fall out. A Computed Tomography (CT) scan revealed that the balloon section contained no retained fluid but appeared to be filled with air. Therefore, following the troubleshooting protocol, health professional removed the catheter using the non-rupture method.It was also mentioned that health professional was present for the tube removal. There is residual air in the balloon section of the device. Based on the CT images taken prior to tube removal, it appears there was slightly more residual air at that time. Need to verify this. Since this patient was transferred from another hospital, the product code is believed to be 7760014LR.
Patient problems: Insufficient Information
MAUDE report 50841690 ↗MalfunctionSep 21, 2026Difficult to Remove
It was reported that the balloon was inserted on (b)(6) 2026. On (b)(6) 2026, when health professional attempted to remove the balloon, the sterile water did not fall out. When the health professional pumped to try to remove it, about 5 mL of water fell out, and the balloon was successfully removed by pulling on the catheter.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50839599 ↗MalfunctionSep 17, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50809592 ↗MalfunctionSep 15, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50782012 ↗InjurySep 15, 2026Material Rupture
Patient problems: Foreign Body In Patient
MAUDE report 50781994 ↗MalfunctionSep 15, 2026Material Split, Cut or Torn
Patient problems: Discomfort
MAUDE report 50781992 ↗MalfunctionSep 15, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50781990 ↗MalfunctionSep 14, 2026Inflation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50765279 ↗MalfunctionSep 14, 2026Material Puncture/Hole
It was reported that while in use the Foley catheter fell out on its own.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50754089 ↗MalfunctionSep 14, 2026Material Puncture/Hole
It was reported that Foley Catheter fell out while in use.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50753087 ↗MalfunctionSep 10, 2026Inaccurate Flow Rate
It was reported that after Foley Catheter insertion, urine flow could not be confirmed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50717394 ↗MalfunctionSep 2, 2026Difficult to Remove
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50562020 ↗MalfunctionAug 28, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50501976 ↗InjuryAug 24, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Peritonitis; Sepsis; Urinary Tract Infection
MAUDE report 50420798 ↗MalfunctionAug 24, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50420784 ↗MalfunctionAug 11, 2026Material Puncture/Hole
It was reported that during use after insertion of foley catheter, a hole opened up and the water used to secure it fell out.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50214132 ↗MalfunctionAug 11, 2026Material Puncture/Hole
It was reported that during placement during surgery when urine volume was checked during surgery, there was almost no urine accumulated. The Foley catheter had spontaneously dislodged, and the leak location was unknown.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50209941 ↗MalfunctionAug 7, 2026Material Puncture/Hole
It was reported that on (b)(6), a catheter was placed in Ward 4A. On (b)(6), while performing perineal cleansing, the catheter spontaneously dislodged even though it had not been pulled. At the time of placement, 10 mL of distilled water was infused into the balloon, but only 3 ml was recovered after removal.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50181600 ↗MalfunctionAug 6, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50156411 ↗MalfunctionJul 31, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50103821 ↗MalfunctionJul 31, 2026Material Puncture/Hole; Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50103820 ↗MalfunctionJul 27, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50025368 ↗MalfunctionJul 21, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25884656 ↗
Other CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES devices
- Bardex® Lubri-Sil® I.C. Temperature-Sensing All-Silicone Foley Catheter 119314C. R. Bard, Inc. · CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES1 recall3,889 reports
- Bardex® I.C. Foley Catheter 0165SI16C. R. Bard, Inc. · CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES1,052 reports
- Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 1758SI14C. R. Bard, Inc. · CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES778 reports
- Bardex® I.C. Temperature Sensing Foley Catheter 129414MC. R. Bard, Inc. · CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES436 reports
- Bardex® Lubri-Sil® I.C. All-Silicone Temp Sensing Foley Catheter 119316MC. R. Bard, Inc. · CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES231 reports
- Bardex® Lubri-Sil® I.C. Temperature-Sensing All-Silicone Foley Catheter 119316C. R. Bard, Inc. · CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES198 reports
- Bardex® I.C. Foley Catheter 0165SI18C. R. Bard, Inc. · CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES181 reports
- SureStep™ Foley Tray System Bardex® I.C. Complete Care Foley Catheter A319416AMC. R. Bard, Inc. · CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES3 recalls18 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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