Bardex® Lubricath® Foley Catheter 0167L18Recalls & reported problems
C. R. Bard, Inc. · Bardex® Lubricath® Latex Foley Catheter 30cc Balloon 3-way Continuous Irrigation 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 Bardex Lubricath Foley catheter is a lubricated latex urinary catheter with a balloon and continuous irrigation. The 26 reports mostly describe the catheter's material tearing or rupturing, the drainage channel becoming blocked or bursting, and the catheter slipping out on its own after insertion. There are no deaths, 1 injury, and no recalls name this device. Reports have dropped in the past 12 months, from 15 to 4.
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
- 29
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00801741018954), received between Jul 16, 2018 and Sep 24, 2026 — classified as 1 injury, 28 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (11 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 Rupture11
- Material Puncture/Hole9
- Complete Blockage2
- Component Missing2
- Burst Container or Vessel1
- Device Damaged Prior to Receipt by User1
- Difficult to Remove1
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions27
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889821 ↗MalfunctionSep 23, 2026Component Missing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873309 ↗MalfunctionJul 29, 2026Material Puncture/Hole; Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50074013 ↗MalfunctionJun 23, 2026Material Rupture
IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON RUPTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25597046 ↗MalfunctionMay 28, 2026Material Puncture/Hole; Material Rupture
IT WAS REPORTED THAT INSERTED ON (B)(6) AND THE FOLEY CATHETER SPONTANEOUSLY DISLODGED ON (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25321935 ↗MalfunctionMar 25, 2026Material Puncture/Hole
IT WAS REPORTED THAT DURING USE THE FOLEY CATHETER HAD FALLEN OUT ON ITS OWN IN THE WARD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24690135 ↗MalfunctionFeb 9, 2026Material Puncture/Hole; Material Rupture
IT WAS REPORTED THAT FOLEY CATHETER WAS INSERTED ON DECEMBER 2ND AND WAS SPONTANEOUSLY REMOVED ON DECEMBER 3RD IN THE OPERATING ROOM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24292015 ↗MalfunctionSep 19, 2025Complete Blockage; Complete Blockage
IT WAS REPORTED THAT AFTER THE FOLEY CATHETER WAS INSERTED, THE CUFF FAILED TO INFLATE. THE DRAINAGE LUMEN WAS ALSO CLOGGED AND BURST UPON PUMPING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23095850 ↗MalfunctionSep 19, 2025Inflation Problem; Inflation Problem
IT WAS REPORTED THAT AFTER THE FOLEY CATHETER WAS INSERTED, THE CUFF FAILED TO INFLATE. THE DRAINAGE LUMEN WAS ALSO CLOGGED AND BURST UPON PUMPING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23095849 ↗MalfunctionSep 19, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT AFTER THE FOLEY CATHETER WAS INSERTED, THE CUFF FAILED TO INFLATE. THE DRAINAGE LUMEN WAS ALSO CLOGGED AND BURST UPON PUMPING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23095847 ↗InjuryJul 18, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON GOT RUPTURED. LINDEL OINTMENT WAS USED FOR THE PATIENT. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 21JUL2025, STATED THAT NO PATIENT IMPACT OR NO SERIOUS INJURY WAS REPORTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22542379 ↗MalfunctionJul 16, 2025Complete Blockage; Complete Blockage
IT WAS REPORTED THAT IMMEDIATELY AFTER PLACEMENT THE FOLEY CATHETER HAD POOR DRAINAGE AS IT GOT CLOGGED SOON AFTER IT WAS STARTED USING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22520477 ↗MalfunctionMay 20, 2025Device Damaged Prior to Receipt by User; Component Missing; Device Damaged Prior to Receipt by User; Component Missing
IT WAS REPORTED THAT CUSTOMER RECEIVED THIS FOLEY CASE, BUT IT WAS ONE EACH SHORT. CUSTOMER WOULD LIKE CREDIT FOR THE ONE EACH THEY WERE MISSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22053978 ↗MalfunctionApr 3, 2025Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT THE FOLEY CATHETER WATER BALLOON WAS LEAKING, WHICH CAUSED THE CATHETER TO SLIP OUT. THE DEFECTIVE ITEM WAS DISCARDED AND REPLACED WITH A NEW SET TO RESOLVE THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21761538 ↗MalfunctionApr 2, 2025Fluid/Blood Leak; Use of Device Problem; Fluid/Blood Leak; Use of Device Problem
IT WAS REPORTED THAT THE URINE FLOWS SPONTANEOUSLY ON THE FOLEY CATHETER THROUGH THE LAVAGE CHANNEL. DURING BLADDER LAVAGE, URINE DOES NOT FLOW DURING NACL INJECTION. HOWEVER, AS SOON AS THE SYRINGE WAS WITHDRAWN, URINE FLOWS THROUGH THE LAVAGE CHANNEL. REPRODUCED SEVERAL TIMES. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 21MAR2025, STATED THAT NO NOTICEABLE HARM, OTHER THAN AN UNPLEASANT REPETITION OF THE SURVEY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21752152 ↗MalfunctionMar 17, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING PLACEMENT, FOLEY CATHETER BALLOON BURST AFTER PLACEMENT IN A FEMALE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21618774 ↗MalfunctionMar 10, 2025Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT THE FOLEY CATHETER IMMEDIATELY AFTER USE, HAD HOLE NEAR THE FUNNEL AND DAMAGED, LEADING TO STERILIZED WATER LEAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21559308 ↗MalfunctionJan 23, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING PRE-TESTING, WHEN STERILE WATER WAS POURED IN, WATER LEAKED FROM THE FOLEY CATHETER VALVE. THE VALVE WAS DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21218400 ↗MalfunctionJan 13, 2025Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT THE FOLEY CATHETER HAD NATURAL REMOVAL, IMMEDIATELY AFTER INSERTION DUE TO HOLE IN CUFF BUT WAS NOT VISIBLE TO THE EYE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21137013 ↗MalfunctionJan 6, 2025Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT THE FOLEY CATHETER WAS INSERTED IN THE OPERATING ROOM TO STOP BLEEDING AND CATHETERIZE THE URINE, AND WHILE THE PATIENT WAS BEING MANAGED IN THE WARD AND CATHETER REMOVED NATURALLY. UPON EXAMINATION, IT WAS FOUND THAT THE BALLOON HAD BEEN DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21079049 ↗MalfunctionDec 31, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT AFTER ONE DAY OF PLACEMENT OF A FOLEY CATHETER AFTER BLADDER CANCER, THE CATHETER WAS REMOVED AND FOUND TO HAVE RUPTURED. THERE WERE NO STONES IN THE BLADDER. THE AMOUNT OF STERILE WATER INJECTED WAS 30CC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21047387 ↗MalfunctionDec 11, 2024Illegible Information; Illegible Information
IT WAS REPORTED THAT WHEN CUSTOMER TRIED TO CHECK THE SIZE BEFORE USE, THE FRENCH SIZE OF FOLEY CATHETER WAS HIDDEN BY THE ATTACHED STICKER, AND THEY COULD NOT CHECK IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20903188 ↗MalfunctionSep 19, 2024Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT DURING A PRETEST, THE STERILE WATER LEAKED FROM THE FOLEY CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20258278 ↗MalfunctionAug 27, 2024Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED THAT AFTER OPENING THE PACKAGE THE SHAFT PART OF THE FOLEY CATHETER NEAR THE FUNNEL WAS CRUSHED FLAT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20076269 ↗MalfunctionMay 29, 2024Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT AN 18 FR FOLEY CATHETER WAS INSERTED INTO A PATIENT WITH A 30CC BALLOON AND THE FLUID WAS UNABLE TO WITHDRAW FROM THE LUER LOCK. THE CATHETER WAS CUT TO RELEASE FLUID AND THE FLUID WAS REMOVED. THE BULB WAS FOUND TO BE BURST, AND ALL PARTS WERE INTACT UPON REMOVAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19417002 ↗
Other CATHETER, UROLOGICAL devices
- Magic3™ Coude Intermittent Catheter with Sure-Grip™ Sleeve 50614C. R. Bard, Inc. · CATHETER, UROLOGICAL883 reports
- Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve 53614GC. R. Bard, Inc. · CATHETER, UROLOGICAL692 reports
- Magic3™ Coude Intermittent Catheter with Sure-Grip™ Sleeve 50616C. R. Bard, Inc. · CATHETER, UROLOGICAL2 deaths443 reports
- GENTLECATH GLIDE 421567Convatec, Purchasing Department · Catheter, Urological342 reports
- Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve 53616GC. R. Bard, Inc. · CATHETER, UROLOGICAL301 reports
- Bardex® Foley Catheter Silicone Coated 0167V22SC. R. Bard, Inc. · CATHETER, UROLOGICAL187 reports
- Bardex® Foley Catheter Silicone Coated 0167V20SC. R. Bard, Inc. · CATHETER, UROLOGICAL175 reports
- Bardia® Coude Olive Tip Urethral Foley Catheter 802516C. R. Bard, Inc. · CATHETER, UROLOGICAL170 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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