Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 1758SI12Recalls & reported problems
C. R. Bard, Inc. · Bardex® Lubri-Sil® I.C. All-Silicone Coated 5 cc Foley Catheter · Class 2
All models of Bardex Lubri-Sil I.C. All-Silicone Foley Catheter (26)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Bard Bardex Lubri-Sil Foley catheter is a urinary catheter with a balloon that holds it in the bladder. Of the 160 reports, 157 are malfunctions, and many describe holes or ruptures in the balloon, components put together incorrectly, and leaks. The reports include no deaths and 3 injuries, and reports fell to 30 in the last 12 months from 113 before. 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
- 165
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 165 adverse event reports that list this exact device (DI 00801741025204), received between Jul 23, 2018 and Sep 4, 2026 — classified as 4 injuries, 161 malfunctions.
The most frequently reported specific device problem is “Material Puncture/Hole” (85 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/Hole85
- Material Rupture59
- Component Misassembled55
- Fluid/Blood Leak12
- Inflation Problem10
- Deflation Problem6
- Material Split, Cut or Torn4
- Complete Blockage2
Patient problems
- No Clinical Signs, Symptoms or Conditions160
- Pain3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
- Urinary Retention1
- Urinary Tract Infection1
Recent adverse event reports
The 25 most recent of 165 reports, in the reporter's own words as published by the FDA.
InjurySep 4, 2026Difficult to Remove
Patient problems: Pain; Urinary Retention
MAUDE report 50621034 ↗MalfunctionAug 26, 2026Material Puncture/Hole
It was reported that the foley catheter, which was placed on (b)(6), had spontaneously dislodged on the (b)(6), Upon examination after the dislodgement, a leak was detected from the balloon section.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50456177 ↗MalfunctionAug 20, 2026Material Puncture/Hole; Material Rupture
It was reported that on the (b)(6) while attempting to place a Foley catheter for urinary drainage by injecting 5 cc of fixation fluid, the balloon portion reportedly ruptured.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50342021 ↗MalfunctionJun 28, 2026Difficult to Remove
It was reported that during use the health professional was able to fill the Foley catheter cuff with water but could not drain it. It was also mentioned that a check on the inside of the tank determined that both filling and draining worked.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25648333 ↗MalfunctionJun 19, 2026Material Puncture/Hole
IT WAS REPORTED THAT DURING USE IN THE OP, THE FOLEY CATHETER EXPERIENCED A MALFUNCTION THAT WATER LEAKED AT THE FIXED UNIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25566048 ↗MalfunctionJun 19, 2026Material Rupture
IT WAS REPORTED THAT AFTER PLACEMENT, FOLEY CATHETER WAS MOVED TO THE ICU A FEW HOURS, SEVERAL HOURS LATER, AND BY THE TIME USER NOTICED, IT HAD COME OUT ON ITS OWN, ACCORDING TO THE REPORT. THERE WERE LARGE CRACKS IN THE BALLOON PORTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25566043 ↗MalfunctionJan 12, 2026Material Twisted/Bent
IT WAS REPORTED THAT ATTEMPTED TO FILL THE FOLEY CATHETER BALLOON WITH WATER, BUT WATER WOULD NOT ENTER AND LEAKED FROM THE CUFF. THE SHAPE OF THE DISTAL TIP WAS DENTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24046301 ↗MalfunctionJan 2, 2026Material Puncture/Hole
IT WAS REPORTED THAT SPONTANEOUS REMOVAL OF THE FOLEY CATHETER WAS CONFIRMED AFTER INSERTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23951649 ↗MalfunctionDec 30, 2025Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT DURING THE PRE TEST, WHEN STERILE WATER WAS INJECTED, IT FLOWED OUT INTO THE DRAINAGE LUMEN OF THE FOLEY CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23930112 ↗MalfunctionDec 30, 2025Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT DURING THE PRETEST, THE FOLEY CATHETER BALLOON DID NOT INFLATE, AND DISTILLED WATER FLOWED INTO THE DRAINAGE LUMEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23930110 ↗MalfunctionDec 30, 2025Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT DURING THE PRE-USE CUFF CHECK, A LEAK WAS DETECTED FROM THE BRANCHING POINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23927662 ↗MalfunctionDec 29, 2025Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT AFTER INSERTION AND BALLOON EXPANSION, THE CATHETER CAME OUT WHEN THEY TRIED TO WITHDRAW IT. THE LOT NUMBER OF THE PRODUCT WAS MYKR3307.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23912998 ↗MalfunctionDec 29, 2025Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT HOLE WAS FOUND IN THE FOLEY CATHETER BALLOON DURING THE PRE-TEST. THE LOT NUMBER OF THE PRODUCT WAS MYKR3307.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23912996 ↗MalfunctionDec 29, 2025Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT HOLE WAS FOUND IN THE FOLEY CATHETER BALLOON DURING THE PRE TEST. THE PROVIDED LOT NUMBER WAS MYKR3307.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23912995 ↗MalfunctionDec 24, 2025Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT DURING PRE-TESTING, STERILE WATER LEAKED FROM THE FOLEY CATHETER. UPON EXAMINING THE DEFECTIVE UNIT, IT WAS SUSPECTED THAT THE LEAK WAS OCCURRING AROUND THE JUNCTION OF THE INFLATION LUMEN AND THE DRAINAGE LUMEN. THIS WAS AN INCIDENT WHERE STERILE WATER LEAKED DURING PRE-TESTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23889619 ↗MalfunctionDec 23, 2025Inflation Problem; Material Puncture/Hole; Inflation Problem; Material Puncture/Hole
IT WAS REPORTED THAT ATTEMPTED TO FILL THE FOLEY CATHETER BALLOON WITH WATER, BUT WATER WOULD NOT ENTER AND LEAKED FROM THE CUFF. THE SHAPE OF THE DISTAL TIP WAS DENTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23879120 ↗MalfunctionDec 10, 2025Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT STERILE WATER LEAKED FROM THE FOLEY CATHETER DURING PRE-TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23771542 ↗MalfunctionDec 10, 2025Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT BEFORE PATIENT USE, CHECKED IF THE BALLOON INFLATES PROPERLY. AFTER CONFIRMING INFLATION, HEALTH PROFESSIONAL ATTEMPTED TO DEFLATE IT, BUT THE DISTILLED WATER RAN OUT FROM THE FOLEY CATHETER. PER INTERNAL BD COMMENTS RECEIVED ON 01DEC2025, LUMEN TO LUMEN HAD OCCURRED. IT APPEARED THAT DISTILLED WATER WAS FLOWING INTO THE CONNECTING TUBE ON THE URINE COLLECTION BAG SIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23768641 ↗MalfunctionDec 5, 2025Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT THE INFLATION LUMEN AND DRAINAGE LUMEN WERE PENETRATED WHEN STERILE WATER WAS INJECTED. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 02DEC2025, STATED THAT THEY WERE UNKNOWN ABOUT ANY CUT OR PINHOLE IN THE LUMEN AREA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23728002 ↗MalfunctionDec 5, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THE FOLEY CATHETER USE WAS DISCONTINUED BECAUSE THERE WAS A WHITE RESIDUE NEAR THE TAMPER EVIDENT SEAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23728000 ↗MalfunctionDec 5, 2025Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT THE FOLEY CATHETER STERILE WATER LEAKED DURING PRETEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23727997 ↗MalfunctionNov 21, 2025Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT DURING PRETESTING, STERILE WATER LEAKED INTO THE DRAINAGE LUMEN OF THE FOLEY CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23616744 ↗MalfunctionNov 21, 2025Material Puncture/Hole; Component Misassembled; Material Puncture/Hole; Component Misassembled
IT WAS REPORTED THAT DURING PRETEST, THE STERILE WATER LEAKED FROM THE FOLEY CATHETER DRAINAGE LUMEN. THE LOCATION OF THE OCCURRENCE HAD NOT BEEN CONFIRMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23615809 ↗MalfunctionNov 21, 2025Material Puncture/Hole; Component Misassembled; Material Puncture/Hole; Component Misassembled
IT WAS REPORTED THAT DURING THE PRETEST; A BANG SOUND WAS HEARD AND STERILE WATER LEAKED. PER FOLLOW UP INFORMATION RECEIVED VIA RCC ON (B)(6) 2025, STATED THAT IT WAS UNKNOWN IF THE BANG SOUND WAS DUE TO BALLOON RUPTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23615798 ↗MalfunctionNov 20, 2025Material Puncture/Hole; Material Rupture; Material Puncture/Hole; Material Rupture
IT WAS REPORTED THAT THE FOLEY CATHETER WAS PLACED AFTER ORTHOPEDIC SURGERY. POSTOPERATIVE OBSERVATION SHOWED NO INCREASE IN URINE OUTPUT, SO WHEN THEY REMOVED THE TAPE SECURING THE CATHETER TO CHECK FOR TWISTING, THE CATHETER SLIPPED OUT SMOOTHLY. THE BALLOON WAS DEFLATED. IT WAS LEAKED FROM THE BALLOON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23604468 ↗
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 0165SI14C. R. Bard, Inc. · CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES1,994 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
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