Bardex® Lubricath® Foley Catheter Creevy Model 01267522Recalls & reported problems
C. R. Bard, Inc. · Bardex® Lubricath® Creevy Model Foley Catheter 3 way Continuous Irrigation 75cc Balloon Lubricious Coated · Class 2
All models of Bardex Lubricath Foley Catheter Creevy Model (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a Bardex Lubricath Foley catheter, a three-way tube used to drain the bladder and irrigate it continuously. The 72 reports mostly describe balloon problems — balloons that will not inflate or deflate, hard or misshapen balloons — plus catheters that are hard to pull out, missing valve caps, and leaking fluid or blood. No deaths and no injuries are mentioned, and 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
- 72
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 00801741018817), received between Nov 13, 2017 and Jul 24, 2025 — classified as 72 malfunctions.
The most frequently reported specific device problem is “Deflation Problem” (31 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
- Deflation Problem31
- Inflation Problem22
- Difficult to Remove15
- Failure to Infuse14
- Fluid/Blood Leak10
- Burst Container or Vessel8
- Material Rupture6
- Decrease in Pressure4
Patient problems
- No Known Impact Or Consequence To Patient57
- No Consequences Or Impact To Patient33
- No Patient Involvement24
- No Clinical Signs, Symptoms or Conditions10
- Not Applicable1
Recent adverse event reports
The 25 most recent of 72 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 24, 2025Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON HAD A SHAPE THAT LOOKS LIKE A DEFLATED BALLOON AND WAS THE BALLOON WAS HARD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22588999 ↗MalfunctionJul 24, 2025Material Too Rigid or Stiff; Material Too Rigid or Stiff
IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON HAD A SHAPE THAT LOOKS LIKE A DEFLATED BALLOON AND WAS THE BALLOON WAS HARD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22588781 ↗MalfunctionApr 17, 2024Component Misassembled; Component Misassembled
IT WAS REPORTED THAT THE FOLEY CATHETER COULD NOT BE USED BECAUSE IT DID NOT HAVE A CAP. PER ADDITIONAL INFORMATION VIA EMAIL FROM IBC ON (B)(6) 2024, THIS WOULD BE THE CAP THAT SHOULD BE ON THE INFLATION VALVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19124585 ↗MalfunctionSep 8, 2023Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT WHEN STERILE WATER WAS INJECTED WITH SYRINGE, IT LEAKED FROM THE FOLEY CATHETER BIFURCATION OF THE SHAFT SECTION. PER FOLLOW-UP INFORMATION RECEIVED FROM IBC ON (B)(6) 2023, STATED THAT THE DEFECT WAS FOUND AFTER USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17710233 ↗MalfunctionFeb 14, 2023Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE INFLATION VALVE WAS BROKEN. WHEN ATTEMPTING TO USE THE CATHETER IN THE OPERATING ROOM, THE SYRINGE DID NOT FIT PROPERLY INTO THE VALVE PORTION. UPON CHECKING, THE INFLATION VALVE HAD BEEN BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16371222 ↗MalfunctionDec 23, 2021Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THERE WAS IRRIGATION LEAKAGE FROM THE FOLEY CATHETER. PATIENT WAS CHANGED WITH A NEW FOLEY CATHETER. PER FOLLOW-UP INFORMATION RECEIVED VIA IBC ON 13DEC2021, STATED THAT THE IRRIGATION LEAKAGE REFERS TO LEAKS IN THE CATHETER AND THERE WAS NO IMPACT TO THE PATIENT AS THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13079254 ↗MalfunctionApr 5, 2021Failure to Infuse; Failure to Infuse
IT WAS REPORTED THAT THE FOLEY CATHETER WAS DIFFICULT TO INFLATE DURING PRETEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11615211 ↗MalfunctionMar 18, 2021Decrease in Pressure; Decrease in Pressure
IT WAS REPORTED THAT THE FOLEY CATHETER FELL OUT FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11517160 ↗MalfunctionOct 26, 2020Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT THE BALLOON OF THE CATHETER SLIGHTLY INFLATED BEFORE USE. PER SAMPLE EVALUATION, IT WAS FOUND THAT ONE OF THE CATHETERS HAD A DENTED BALLOON AND FOUR CATHETERS COULD NOT COMPLETELY DEFLATE.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10737685 ↗MalfunctionOct 13, 2020Failure to Infuse; Inflation Problem; Failure to Infuse
IT WAS REPORTED THAT THE CATHETER WAS DIFFICULT TO INFLATE AFTER THE PLACEMENT. PER ADDITIONAL INFORMATION VIA EMAIL FROM IBC ON 25SEP2020, THERE WAS NO IMPACT TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10671945 ↗MalfunctionJul 22, 2020Inflation Problem
IT WAS REPORTED THAT THE BALLOON OF THE CATHETER WAS SLIGHTLY INFLATED BEFORE USE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10309441 ↗MalfunctionJul 22, 2020Break; Decrease in Pressure; Decrease in Pressure
IT WAS REPORTED THAT THE CATHETER BALLOON WAS BROKEN. PER ADDITIONAL INFORMATION RECEIVED VIA MAIL FROM THE IBC ON 28JUL2020, NO MISSING PIECES OF THE BALLOON WAS FOUND. AS PER THE INVESTIGATION NOTIFICATION, THE DEVICE FOUND TO HAVE A LUMEN TO LUMEN LEAKAGE.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 10308141 ↗MalfunctionJul 21, 2020Inflation Problem
IT WAS REPORTED THAT THE BALLOON OF THE CATHETER WAS SLIGHTLY INFLATED BEFORE USE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10302744 ↗MalfunctionJul 21, 2020Inflation Problem
IT WAS REPORTED THAT THE BALLOON OF THE CATHETER WAS SLIGHTLY INFLATED BEFORE USE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10302732 ↗MalfunctionJul 21, 2020Inflation Problem
IT WAS REPORTED THAT THE BALLOON OF THE CATHETER SLIGHTLY INFLATED BEFORE USE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10302725 ↗MalfunctionJun 16, 2020No Apparent Adverse Event; Gas/Air Leak; No Apparent Adverse Event
IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON WAS SUSPECTED OF HAVING AIR EVEN BEFORE OPENING IT FOR USE. IT WAS NOTED THAT A NEW FOLEY HAD BEEN UNPACKED FOR USE.
Patient problems: No Known Impact Or Consequence To Patient; Not Applicable
MAUDE report 10157538 ↗MalfunctionJun 5, 2020Burst Container or Vessel; Burst Container or Vessel; Material Rupture
IT WAS REPORTED THAT THE BALLOON RUPTURED DURING PRETEST.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 10122246 ↗MalfunctionMay 6, 2020Burst Container or Vessel; Burst Container or Vessel; Material Rupture
IT WAS REPORTED BALLOON OF THE CATHETER RUPTURED. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 24 APRIL 2020 FROM IBC REPRESENTATIVE, THERE WERE NO MISSING PIECES OF THE BALLOON.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 10029292 ↗MalfunctionMay 1, 2020Decrease in Pressure; Fluid/Blood Leak; Decrease in Pressure
IT WAS REPORTED THAT A WATER LEAK OCCURRED DURING PRETEST.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 10017834 ↗MalfunctionApr 29, 2020Difficult to Remove; Deflation Problem; Difficult to Remove
IT WAS REPORTED THAT DURING THE EVALUATION OF THE SAMPLE, IT WAS FOUND THAT THE CATHETER BALLOON WOULD NOT DEFLATE COMPLETELY.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 10011665 ↗MalfunctionApr 27, 2020Difficult to Remove; Deflation Problem; Difficult to Remove
IT WAS REPORTED THAT THE CATHETER BALLOON WOULD NOT COMPLETELY DEFLATE DURING THE SAMPLE EVALUATION.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 10001619 ↗MalfunctionApr 2, 2020Fluid/Blood Leak; Failure to Infuse; Failure to Infuse
IT WAS REPORTED THAT A WATER LEAK OCCURRED DURING PRETEST.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 9915407 ↗MalfunctionApr 2, 2020Fluid/Blood Leak; Decrease in Pressure; Decrease in Pressure
IT WAS REPORTED THAT A WATER LEAK OCCURRED DURING PRETEST.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 9915406 ↗MalfunctionApr 1, 2020Deflation Problem; Component Misassembled; Component Misassembled
IT WAS REPORTED PRIOR TO USE ON THE PATIENT, THAT THE BALLOON COULD NOT BE DEFLATED DURING TESTING. DURING EVALUATION IT WAS FOUND THAT THE CATHETER IRRIGATION FUNNEL WAS NOT FORMED CORRECTLY.
Patient problems: No Patient Involvement
MAUDE report 9914071 ↗MalfunctionFeb 26, 2020Deflation Problem; Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT THE BALLOON COULD NOT BE FULLY DEFLATED. PER ADDITIONAL INFORMATION FROM THE IBC VIA EMAIL 13FEB2020; THE WATER WAS DIFFICULT TO REMOVE. THE USER TRIED SEVERAL TIMES TO DEFLATE THE BALLOON, REMOVING WATER EACH TIME. FINALLY THE DEVICE WAS REMOVED WITH THE BALLOON PARTIALLY INFLATED. NO FURTHER MEDICAL INTERVENTION WAS REQUIRED.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 9759054 ↗
Other CATHETER, COUDE devices
- Bardex® Lubricath® Foley Catheter 0165L14C. R. Bard, Inc. · CATHETER, COUDE562 reports
- 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
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.
How reports and recalls are matched · Editorial policy · Report an error on this page