Bardex® Lubricath® Foley Catheter 0165L14Recalls & reported problems
C. R. Bard, Inc. · Bardex® Lubricath® Foley Catheter 5cc Balloon Lubricious Coated · Class 2
All models of Bardex Lubricath Foley Catheter (38)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Bard Lubricath Foley catheter is a urinary catheter with an inflatable balloon. Its 561 reports mostly describe balloons that puncture or rupture, fail to inflate or deflate, and catheters that are hard to remove. The reports include no deaths and 29 injuries; a few mention a foreign body in the patient. Reports fell from 314 in the earlier 12 months to 146 in the latest 12 months. No recalls name this device.
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
- 562
- Deaths reported
- 0
- Injuries reported
- 28
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 562 adverse event reports that list this exact device (DI 00801741017476), received between Oct 21, 2017 and Sep 29, 2026 — classified as 28 injuries, 534 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (126 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
- Material Rupture126
- Material Puncture/Hole115
- Deflation Problem99
- Difficult to Remove47
- Inflation Problem45
- Disconnection27
- Material Fragmentation25
- Fluid/Blood Leak23
Patient problems
- No Clinical Signs, Symptoms or Conditions500
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available18
- No Known Impact Or Consequence To Patient16
- Foreign Body In Patient13
- No Consequences Or Impact To Patient13
- Pain8
- Hematuria5
- Incontinence4
Recent adverse event reports
The 25 most recent of 562 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940868 ↗MalfunctionSep 28, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926205 ↗MalfunctionSep 28, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926183 ↗MalfunctionSep 28, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923633 ↗MalfunctionSep 28, 2026Material Rupture
Patient problems: Foreign Body In Patient
MAUDE report 50917214 ↗MalfunctionSep 25, 2026Material Rupture
It was reported that nurse in Gloucester and had been out to a patient today who has had an issue with the catheter that was inserted on Tuesday (b)(6).They had been using a catheter valve effectively but when passing urine, they heard a noise like a deflating balloon and her catheter expelled. They kept this for me to review today and there is a noticeable spilt in the ballon for inflation. I have attached the photo for you to review.I just wondered if there has been any other issue with a batch of catheters. The one inserted was (b)(6) exp 15.9.28.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50900321 ↗MalfunctionSep 21, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848298 ↗MalfunctionSep 17, 2026Inflation Problem
It was reported that during use there was a hole in the foley catheter balloon, and it was expelled naturally.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50809610 ↗MalfunctionSep 16, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50790370 ↗MalfunctionSep 11, 2026Device Dislodged or Dislocated
It was reported that Spontaneous dislodgement of the Foley Catheter occurred after placement. No damage to the balloon section was observed. There may be an issue with the lumen partway along the catheter.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50734402 ↗MalfunctionSep 1, 2026Deflation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50547366 ↗MalfunctionAug 28, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50506880 ↗MalfunctionAug 25, 2026Material Rupture
It was reported that during use the Foley catheter after insertion in the operating room, just as health professional had injected 8 ml of water, health professional heard a popping sound. When health professional removed the device, health professional found that the balloon had suffered a rupture.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50427839 ↗MalfunctionAug 12, 2026Material Puncture/Hole; Device Dislodged or Dislocated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50222421 ↗MalfunctionAug 11, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50213963 ↗MalfunctionAug 11, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50209942 ↗MalfunctionAug 7, 2026Use of Device Problem
It was reported that on Insertion of Foley catheter normal procedure for bard tray and 10 ml inflation of ballon as per normal procedure. Same nurse visited 10 days later due to blocked catheter and on removal of catheter met with resistance after initial deflation with 10 ml syringe and further 10 ml removed therefore inflation balloon now had 20 ml in. Human error at time of insertion ruled out. Cannot quantify if human interference post insertion. Yellow card to rule out manufacturing problem i.e. saline in inflation syringe.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50179361 ↗MalfunctionAug 6, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50160201 ↗MalfunctionAug 5, 2026Partial Blockage; Complete Blockage
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50148802 ↗MalfunctionJul 31, 2026Deflation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50105786 ↗MalfunctionJul 31, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50105784 ↗MalfunctionJul 30, 2026Material Puncture/Hole; Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50091036 ↗MalfunctionJul 30, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50087304 ↗MalfunctionJul 27, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50022132 ↗MalfunctionJul 21, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25884694 ↗
Other CATHETER, COUDE devices
- Bardex® Lubricath® Foley Catheter 0165L16C. R. Bard, Inc. · CATHETER, COUDE539 reports
- Bardia® Foley Catheter Silicone Coated 123516AC. R. Bard, Inc. · CATHETER, COUDE381 reports
- Bardia® Foley Catheter Silicone Coated 123514AC. R. Bard, Inc. · CATHETER, COUDE195 reports
- SureStep™ Foley Tray System Bardex® Lubricath® Foley Catheter A899916C. R. Bard, Inc. · CATHETER, COUDE3 recalls19 reports
- Bardia® Foley Catheter Silicone Coated 123518AC. R. Bard, Inc. · CATHETER, COUDE153 reports
- SureStep™ Foley Tray System Bardex® Lubricath® Foley Catheter A902916C. R. Bard, Inc. · CATHETER, COUDE2 recalls50 reports
- Bard® Lubricath® Foley Catheter 365716C. R. Bard, Inc. · CATHETER, COUDE117 reports
- SureStep™ Foley Tray System Bard® Lubricath Foley A800365C. R. Bard, Inc. · CATHETER, COUDE2 recalls12 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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