BardexLubricath Foley Catheter Alcock ModelRecalls & reported problems across all models
C. R. Bard, Inc. · 3 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 68
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 3 models of BardexLubricath Foley Catheter Alcock Model by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 68 adverse event reports in the FDA's MAUDE database, received between Apr 13, 2017 and Mar 26, 2025 — classified as 68 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (12 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported BardexLubricath Foley Catheter Alcock Model problems
Device problems
- Burst Container or Vessel12
- Inability to Irrigate7
- Material Puncture/Hole7
- Deflation Problem6
- Failure to Infuse6
- Inflation Problem6
- Material Fragmentation6
- Misassembled6
Patient problems
- No Clinical Signs, Symptoms or Conditions34
- No Known Impact Or Consequence To Patient31
- No Consequences Or Impact To Patient27
- No Patient Involvement6
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
BardexLubricath Foley Catheter Alcock Model models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Bardex®Lubricath® Foley Catheter Alcock Model 0134L20CATHETER, UROLOGICAL27 reports
- Bardex®Lubricath® Foley Catheter Alcock Model 0134L18CATHETER, UROLOGICAL25 reports
- Bardex®Lubricath® Foley Catheter Alcock Model 0134L22CATHETER, UROLOGICAL16 reports
Recent BardexLubricath Foley Catheter Alcock Model adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 26, 2025Inflation Problem; Inflation Problem
IT WAS REPORTED THAT DURING PLACEMENT, THEY TRIED TO INFLATE THE FOLEY CATHETER BALLOON WITH STERILE WATER, BUT IT DID NOT GO IN. THEY WAS ABLE TO INJECT SOME WATER, BUT THE AMOUNT WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21697041 ↗MalfunctionFeb 20, 2025Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT THIS WAS A WATER LEAK. WHEN SALINE WAS INJECTED, A LEAK OCCURRED FROM THE IRRIGATION LUMEN OF THE FOLEY CATHETER. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 06FEB2025, CUSTOMER CONFIRMED THAT PATIENT INVOLVED BUT NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21421477 ↗MalfunctionDec 13, 2024Inaccurate Flow Rate; Inaccurate Flow Rate
IT WAS REPORTED THAT AFTER PLACEMENT OF FOLEY CATHETER, URINE DID NOT FLOW. AFTER REMOVAL, THE URINE FLOWED AFTER FLUSHING WITH STERILE DISTILLED WATER. HOWEVER, THE HOSPITAL REQUESTED TO INVESTIGATE THE PRODUCT TO SEE IF THERE WAS A DEFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20924607 ↗MalfunctionOct 22, 2024Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT THE STERILE WATER LEAKED FROM THE BALLOON AREA OF THE FOLEY CATHETER DURING A PRETEST. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 10OCT2024, STATED THAT CUSTOMER CONFIRMED THAT PATIENT WAS NOT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20509279 ↗MalfunctionFeb 16, 2024Material Puncture/Hole; Material Split, Cut or Torn; Material Puncture/Hole; Material Split, Cut or Torn
IT WAS REPORTED THAT WATER LEAKED THROUGH A HOLE IN THE TIP OF THE FOLEY CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18719892 ↗MalfunctionSep 1, 2023Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED THAT THE FOLEY CATHETER WITHDREW WHEN RETURNING TO THE WARD AFTER USE. THEN THE BALLOON WAS RUPTURED. THERE WERE NO MISSING PIECES. THERE WERE NO REMAINS IN THE BODY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17671146 ↗MalfunctionJul 5, 2023Failure to Infuse; Failure to Infuse
IT WAS REPORTED THAT STERILE WATER COULD NOT BE INJECTED WHEN ATTEMPTED TO INJECT AFTER THE CATHETER INSERTION. ACCORDING TO THE INQUIRY SHEET ATTACHED, THE PRETEST WAS NOT DONE AND THERE WAS NO PROBLEM OBSERVED DURING INFLATION OF THE CATHETER. THE INFLATION FUNNEL DID NOT SWELL AND THERE WAS NO ABNORMALITY OBSERVED WITH THE SHAFT. USUALLY THE BALLOON COULD BE INFLATED WITHIN SECONDS, BUT SINCE THE PLUNGER COULD NOT BE PUSHED, THE BALLOON COULD NOT BE DEFLATED. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON (B)(6) 2023, IT WAS REPORTED THAT WATER WAS UNABLE TO INJECT INTO THE CATHETER. THE PLUNGER ISSUE WAS NOT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17255271 ↗MalfunctionMay 15, 2023Failure to Infuse; Failure to Infuse
IT WAS REPORTED THAT STERILE WATER DID NOT ENTER THE FOLEY CATHETER THROUGH THE INFLATION VALVE. INJECTING STERILE WATER FROM THE INFLATION VALVE AFTER THE FOLEY CATHETER INSERTION TO THE PATIENT, THE WATER WAS UNABLE TO INJECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16931339 ↗MalfunctionApr 10, 2023Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED THAT THE BALLOON BURST. THE CATHETER FELL OFF AFTER INSERTION TO THE PATIENT. UPON CHECKING THE CATHETER, THE BALLOON WAS FOUND BURST. THE EVENT OCCURRED AFTER 5 HOURS OF PLACEMENT TO THE PATIENT. NO MATERIALS POSSIBLY CAME IN CONTACT WITH THE CATHETER. THERE WAS NO PATIENT URINE STONE, AND THE CATHETER WAS NOT PULLED BY HAND.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16706907 ↗MalfunctionFeb 10, 2023Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn
IT WAS REPORTED THAT WATER LEAKED OUT FROM THE VALVE OF THE FOLEY CATHETER DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16351893 ↗MalfunctionNov 28, 2022Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT THE FOLEY CATHETER FELL OUT OF THE PATIENT DUE TO STERILE WATER LEAKAGE. THE CATHETER WAS INSERTED TO THE PATIENT AFTER OPERATION AND THERE WAS NO PROBLEM DURING THE PRETEST. HOWEVER, WHEN THE PATIENT RETURNED TO THE WARD, THE CATHETER HAD FALLEN OFF. WHEN THE USER CHECKED THE CATHETER AGAIN, WATER LEAKED FROM THE DRAINAGE FUNNEL. IT WAS STATED THAT THE EVENT HAPPENED SIX HOURS AFTER PLACEMENT. THERE WAS NO RUPTURE OR TEAR IN THE BALLOON. WATER LEAKED FROM THE DRAINAGE EYE INTO THE INLET TUBE. NO MATERIALS WERE POSSIBLY THERE IN CONTACT WITH THE CATHETER AND THE CATHETER WAS INSERTED BY HAND. IT WAS MENTIONED THAT HEALTH HAZARDS TO THE PATIENT WERE UNKNOWN. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 22-NOV-2022, STATED THAT THERE WERE NO HEALTH DAMAGES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15869731 ↗MalfunctionSep 21, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THERE WAS A HARD-PLASTIC PIECE NOTED TO BE INSIDE LUMEN OF FOLEY CATHETER AND IT WAS NOT USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15461927 ↗MalfunctionSep 12, 2022Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT THE FOLEY CATHETER SPONTANEOUSLY FELL OUT ON THE NEXT DAY AFTER PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15401281 ↗MalfunctionAug 18, 2022Failure to Infuse; Failure to Infuse
IT WAS REPORTED THAT IT WAS DIFFICULT TO INJECT STERILE WATER INTO THE FOLEY CATHETER BALLOON. IT WAS STATED THAT HEALTH DAMAGE TO THE PATIENT WAS NOT CLEAR.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 15248300 ↗MalfunctionJul 26, 2022Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT THERE WAS A CRACK IN THE FOLEY BALLOON AND THE CATHETER FELL OUT ON THE 14TH DAY OF USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15103542 ↗
Other C. R. Bard, Inc. products
- Bardex I.C. Foley Catheter26 models · 3,607 reports
- Bardex Lubricath Foley Catheter38 models · 1,670 reports · 1 recall
- Bardex Lubri-Sil I.C. All-Silicone Foley Catheter26 models · 1,518 reports
- Magic3 Coude Intermittent Catheter with Sure-Grip Sleeve5 models · 1,466 reports
- Magic3 Intermittent Catheter with Sure-Grip Sleeve14 models · 1,310 reports
- Bardia Foley Catheter Silicone Coated19 models · 1,283 reports
- PureWick Female External Catheter5 models · 1,184 reports
- Bardex All-Silicone Foley Catheter12 models · 1,170 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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