Bardex® Lubricath® Foley Catheter 0165L18Recalls & 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 Bardex Lubricath Foley catheter, a urinary catheter with a balloon that holds it in the bladder, has 115 adverse event reports on file. Many describe holes or ruptures in the catheter or balloon, and some describe leaks, inflation problems or blockages. The reports include no deaths and 7 injuries, 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
- 111
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 111 adverse event reports that list this exact device (DI 00801741017490), received between Jun 13, 2017 and Aug 26, 2026 — classified as 7 injuries, 104 malfunctions.
The most frequently reported specific device problem is “Material Puncture/Hole” (29 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 Puncture/Hole29
- Material Rupture16
- Fluid/Blood Leak10
- Inflation Problem8
- Decrease in Pressure7
- Deflation Problem7
- Material Split, Cut or Torn6
- Difficult to Remove5
Patient problems
- No Clinical Signs, Symptoms or Conditions83
- No Known Impact Or Consequence To Patient14
- No Consequences Or Impact To Patient10
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available5
- Blood Loss2
- No Patient Involvement2
- Pain2
- Bowel Perforation1
Recent adverse event reports
The 25 most recent of 111 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 26, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50459572 ↗MalfunctionAug 11, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50209948 ↗MalfunctionAug 4, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50136359 ↗MalfunctionAug 4, 2026Component Misassembled
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50135456 ↗MalfunctionJun 2, 2026Material Puncture/Hole
IT WAS REPORTED THAT SPONTANEOUS DISCHARGE THE DAY AFTER PLACEMENT DUE TO THE LEAK FROM THE BALLOON SECTION FROM FOLEY CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25367858 ↗MalfunctionMay 4, 2026Material Puncture/Hole
IT WAS REPORTED THAT THE PRETEST WAS PERFORMED WITHOUT ISSUES HOWEVER, WATER LEAKAGE FROM THE FOLEY CATHETER BALLOON WAS OBSERVED THE FOLLOWING MORNING ON THE SECOND DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25074375 ↗MalfunctionMay 1, 2026Material Rupture
IT WAS REPORTED THAT 4 DAYS AFTER PLACEMENT, PLACED ON (B)(6), ON (B)(6), THE FOLEY CATHETER WAS FOUND TO HAVE SPONTANEOUSLY DISLODGED. UPON INSPECTION, THE CUFF WAS FOUND TO BE DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25061277 ↗MalfunctionApr 28, 2026Material Rupture
IT WAS REPORTED THAT ONE DAY AFTER PLACEMENT THE FOLEY CATHETER HAD URINE LEAKAGE AND THE BALLOON WAS FOUND TO BE RUPTURED WHEN REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25023077 ↗MalfunctionMar 7, 2026Complete Blockage
IT WAS REPORTED THAT ONE GOT CLOGGED AND FAILED. NO ADDITIONAL INFORMATION PROVIDED. NO TROUBLESHOOTING WAS PROVIDED. NO MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24539929 ↗MalfunctionFeb 12, 2026Material Puncture/Hole; Material Rupture
IT WAS REPORTED THAT FOLEY CATHETER PLACEMENT ON (B)(6) 2026, AND SPONTANEOUS REMOVAL ON (B)(6), CUFF DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24323364 ↗MalfunctionJan 12, 2026Disconnection
IT WAS REPORTED THAT DURING USE THE FOLEY CATHETER INFLATION VALVE HAD DETACHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24031524 ↗MalfunctionJan 8, 2026Inflation Problem
IT WAS REPORTED THAT, THE URINARY FOLEY CATHETER BALLOON COULD NOT BE INFLATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24005778 ↗MalfunctionDec 31, 2025Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT THE CUSTOMER STATED THAT THE BARDEX LUBRICATH FOLEY CATHETER (SKU 0165L18) FROM LOT #NGHT1869 WAS USED WITHOUT ANY ISSUES. HOWEVER, THE NEW SHIPMENT FROM LOT #NGKW0709 APPEARED LARGER, AND THE PATIENT REPORTED PAIN DURING USE. THEY INFORMED THE CUSTOMER THAT, ALTHOUGH LOT NUMBERS MIGHT VARY, PRODUCTS WITH THE SAME REFERENCE NUMBER SHOULD BE IDENTICAL. THEY ADVISED CONSULTING A UROLOGIST AND ASSURED THEM THAT THEY WOULD ESCALATE THAT MATTER TO THE PRODUCT COMPLAINT TEAM FOR FURTHER INVESTIGATION.
Patient problems: Pain
MAUDE report 23936707 ↗MalfunctionDec 19, 2025Disconnection; Disconnection
IT WAS REPORTED THAT DURING PLACEMENT THE FOLEY CATHETER VALVE CAME OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23855475 ↗MalfunctionDec 4, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT URINARY LEAKAGE OCCURRED FROM THE URETHRA IN PATIENTS WITH FOLEY CATHETER PLACEMENT. IT WAS ALSO MENTIONED NEITHER THE PATIENT NOR THE AGENCY WAS AWARE OF ANY PROBLEMS. TAKIGAWA CONFIRMED THIS BY PHONE WITH THE AGENCY. WHEN CONFIRMING THE USER, THE CONTACT PERSON WAS OUT OF THE OFFICE. THE SUBSTITUTE CONTACT MENTIONED THAT THE SIZE LIKELY NO LONGER FITS. HOWEVER, THERE WAS A MENTION OF A LEAK, AND THE CONTACT PERSON WAS UNABLE TO CONFIRM IF THERE WAS AN ACTUAL DEFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23716200 ↗MalfunctionNov 24, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A FOLEY CATHETER WAS PLACED DURING SURGERY. AFTER SURGERY, THE PATIENT REPORTEDLY TOOK A SHOWER, AND THE CATHETER CAME OUT NATURALLY. THE BALLOON WAS RUPTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23638679 ↗MalfunctionNov 19, 2025Material Puncture/Hole; Material Rupture; Material Puncture/Hole; Material Rupture
IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON BURST DURING THE PRE-TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23594345 ↗MalfunctionNov 19, 2025Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT DURING PRE-TESTING, STERILE WATER LEAK FROM FUNNEL OF THE FOLEY CATHETER WAS DISCOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23594336 ↗MalfunctionOct 30, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT SEVERAL HOURS AFTER PLACEMENT ON THE (B)(6) 2025, THERE WAS SPONTANEOUS REMOVAL OF THE FOLEY CATHETER DUE TO BALLOON RUPTURE ON THE SAME DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23427705 ↗MalfunctionOct 27, 2025Deflation Problem; Material Puncture/Hole; Deflation Problem; Material Puncture/Hole
IT WAS REPORTED THAT DURING PRE-TEST THE FOLEY CATHETER HAD DIFFICULTY IN DRAINING WATER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23398895 ↗MalfunctionOct 27, 2025Deflation Problem; Deflation Problem
IT WAS REPORTED THAT DURING THE PRE-TEST THIS WAS AN INCIDENT OF THE FOLEY CATHETER WHERE IT WAS DIFFICULT TO DRAIN WATER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23395424 ↗MalfunctionOct 17, 2025Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT DURING THE PRETEST THE FOLEY CATHETER STERILE WATER LEAKED FROM THE FUNNEL AREA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23322318 ↗MalfunctionSep 18, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT, BUG INCASED IN STERILE FOLEY CATHETER PACKAGE, PACKAGING REMAINED INTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23083505 ↗MalfunctionSep 10, 2025Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT PRODUCT HAD A HOLE IN FOLEY CATHETER BIFURCATION. (PCN#165818, PCN#0165L18). PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 25SEP2025, IT WAS REPORTED THAT THE PRODUCT WAS ALREADY RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23014704 ↗MalfunctionJul 15, 2025Material Puncture/Hole; Material Split, Cut or Torn; Material Puncture/Hole; Material Split, Cut or Torn
IT WAS REPORTED THAT DURING PRE-TESTING, STERILE WATER LEAKED FROM A CRACK ABOUT 1 MM IN SIZE IN THE FOLEY CATHETER SLIGHTLY ABOVE THE INFLATION VALVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22505582 ↗
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.
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