Bard Foley Catheter Silicone CoatedRecalls & reported problems across all models
C. R. Bard, Inc. · 10 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 44
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 0
We found 10 models of Bard Foley Catheter Silicone Coated by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 44 adverse event reports in the FDA's MAUDE database, received between Jul 24, 2017 and Jun 26, 2025 — classified as 4 injuries, 40 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (6 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 Bard Foley Catheter Silicone Coated problems
Device problems
- Burst Container or Vessel6
- Fluid/Blood Leak5
- Partial Blockage5
- Deflation Problem4
- Difficult to Remove4
- Failure to Infuse4
- Break2
- Complete Blockage2
Patient problems
- No Clinical Signs, Symptoms or Conditions17
- No Consequences Or Impact To Patient17
- No Known Impact Or Consequence To Patient9
- Foreign Body In Patient3
- No Information3
- Pain3
- Insufficient Information1
- Unspecified Infection1
Bard Foley Catheter Silicone Coated models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Bard® Foley Catheter Silicone Coated 265716CATHETER, COUDE12 reports
- Bard® Foley Catheter Silicone Coated 265720CATHETER, COUDE9 reports
- Bard® Foley Catheter Silicone Coated 265714CATHETER, COUDE7 reports
- Bard® Foley Catheter Silicone Coated 265718CATHETER, COUDE6 reports
- Bard® Foley Catheter Silicone Coated 265724CATHETER, COUDE3 reports
- Bard® Foley Catheter Silicone Coated 265722CATHETER, COUDE2 reports
- Bard® Foley Catheter Silicone Coated 266726CATHETER, UROLOGICAL2 reports
- Bard® Foley Catheter Silicone Coated 265728CATHETER, COUDE1 report
- Bard® Foley Catheter Silicone Coated 266716CATHETER, UROLOGICAL1 report
- Bard® Foley Catheter Silicone Coated 266722CATHETER, UROLOGICAL1 report
Recent Bard Foley Catheter Silicone Coated adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 26, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT THE NURSE HAD A FOLEY CATHETER (266726), STATED LABEL ISSUE DATE 10/97. STATED THAT THEY PRETESTED THE BALLOON AND WHEN THEY DID IT DISINTEGRATED. LOT: 87HNR116. EXPLAINED THE LABEL ISSUE DATE WHEN THE LABEL WAS CREATED. THIS ITEM WAS MANUFACTURED IN AUGUST 2003. EXPLAINED HOW IT HAD A SHELF LIFE OF FIVE YEARS, AND THEY CANNOT RECOMMEND USE BEYOND THIS. CUSTOMER WAS NOT HAPPY THERE WAS NO EXPIRATION DATE. EXPLAINED MOST PRODUCTS GOING FORWARD WOULD HAVE AN EXPIRATION DATE ON THE PACKAGING, BUT THOSE OLDER PRODUCTS MAY NOT. FORWARDED TO COMPLAINTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22337345 ↗InjuryMay 3, 2024Device Handling Problem; Device Handling Problem
IT WAS REPORTED THAT THE FOLEY CATHETER TIP BROKE OFF WHEN THE PATIENT PULLED THE CATHETER. STATED THAT THE PATIENT WAS ADMITTED INTO THIS FACILITY WITH THE CATHETER INSTALLED AND THE PATIENT HAD TO BE SENT BACK TO THE ACUTE CARE HOSPITAL TO HAVE THE TIP REMOVED, PATIENT WAS CURRENTLY IN THAT HOSPITAL.
Patient problems: Foreign Body In Patient
MAUDE report 19238863 ↗MalfunctionJul 20, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE PATIENT HAD TO CHANGE THE FOLEY AFTER 2 DAYS OF LEAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17358112 ↗InjuryFeb 1, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE EMERGENCY ROOM CAUSED MOLD ON SILICONE FOLEY CATHETER TO GREEN COLOR, OTHER WERE YELLOW. THE PATIENT DID NOT LIKE THE CATHETERS AND HAD PROBLEMS WITH 2 18FR 5CC, WANTED TO TRY ANOTHER SUPPLIER. IT WAS UNKNOWN IF THE DEVICE CAUSED THE INFECTION AND UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR THE INFECTION AT THIS TIME.
Patient problems: Unspecified Infection
MAUDE report 16277505 ↗MalfunctionDec 28, 2022Disconnection; Disconnection
IT WAS REPORTED THAT THE CUSTOMER WAS TRYING TO USE A SILICONE ELASTOMER FOLEY CATHETER, AND THE INFLATION PORT CAME OFF WHILE TRYING TO INFLATE THE CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16060683 ↗MalfunctionDec 22, 2022Partial Blockage; Partial Blockage
IT WAS REPORTED THAT THE FOLEY CATHETER WAS GETTING CLOGGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16036154 ↗MalfunctionOct 26, 2022Failure to Infuse; Failure to Infuse
IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON DID NOT EXPAND.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15673283 ↗InjurySep 21, 2022Material Rupture; Material Rupture
IT WAS REPORTED THAT THERE WAS AN ALLEGED POTENTIAL FOR DEATH; HOWEVER, THE ACTUAL ISSUE IS UNKNOWN. PULLED FROM HEALTH CANADA¿S MEDICAL DEVICES ONLINE DATABASES. PER FOLLOW-UP INFORMATION RECEIVED ON (B)(6) 2022, FOLEY CATHETER DID NOT DRAIN FOR 6-HOURS AND URINE WAS NOTED TO BE BYPASSING. THE USER ATTEMPTED TO DEFLATE BALLOON TO REMOVE FROM BLADDER WHICH WAS UNABLE TO DO SO . THE CATHETER CLAMPED TO DETACH WHEN BALLOON POPPED INSIDE BLADDER AND THE PATIENT FELT PAIN. CATHETER WAS REMOVED WITH PIECE OF SILICONE THAT MADE UP BALLOON MISSING. CYSTOSCOPY HAD BEEN ORDERED IN ORDER TO REMOVE PIECE OF SILICONE FROM PATIENT'S BLADDER TO PREVENT SEPSIS.
Patient problems: Foreign Body In Patient; Pain
MAUDE report 15461639 ↗MalfunctionSep 15, 2022Difficult to Remove; Component Misassembled; Difficult to Remove; Component Misassembled
IT WAS REPORTED THAT THERE WAS AN ALLEGED POTENTIAL FOR DEATH; HOWEVER, THE ACTUAL ISSUE IS UNKNOWN. PULLED FROM HEALTH CANADA¿S MEDICAL DEVICES ONLINE DATABASES. AS PER FOLLOW-UP INFORMATION RECEIVED ON 30AUG2022, FOLEY CATHETER DID NOT DRAIN FOR 6HOURS AND URINE WAS NOTED TO BE BYPASSING. THE USER ATTEMPTED TO DEFLATE BALLOON TO REMOVE FROM BLADDER WHICH WAS UNABLE TO DO SO. THE CATHETER CLAMPED TO DETACH WHEN BALLOON POPPED INSIDE BLADDER AND THE PATIENT FELT PAIN . CATHETER WAS REMOVED WITH PIECE OF SILICONE THAT MADE UP BALLOON MISSING. CYSTOSCOPY HAD BEEN ORDERED IN ORDER TO REMOVE PIECE OF SILICONE FROM PATIENT'S BLADDER TO PREVENT SEPSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15427744 ↗MalfunctionSep 13, 2022Inaccurate Flow Rate; Inaccurate Flow Rate
IT WAS REPORTED THAT THERE WAS AN ALLEGED POTENTIAL FOR DEATH; HOWEVER, THE ACTUAL ISSUE IS UNKNOWN. PULLED FROM HEALTH CANADA¿S MEDICAL DEVICES ONLINE DATABASES . AS PER FOLLOW-UP INFORMATION RECEIVED ON 30AUG2022, FOLEY CATHETER DID NOT DRAIN FOR 6HOURS, AND URINE WAS NOTED TO BE BYPASSING . THE USER ATTEMPTED TO DEFLATE BALLOON TO REMOVE FROM BLADDER WHICH WAS UNABLE TO DO SO. THE CATHETER CLAMPED TO DETACH WHEN BALLOON POPPED INSIDE BLADDER AND THE PATIENT FELT PAIN . CATHETER WAS REMOVED WITH PIECE OF SILICONE THAT MADE UP BALLOON MISSING. CYSTOSCOPY HAD BEEN ORDERED TO REMOVE PIECE OF SILICONE FROM PATIENT'S BLADDER TO PREVENT SEPSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15410134 ↗MalfunctionMay 11, 2022Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED THAT SOME OF THE FOLEY CATHETER BALLOONS BURST ON THE PATIENT AND IT WAS TIME TO CHANGE THE CATHETER, BUT THE PATIENT DID NOT EVEN BOTHER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14355688 ↗MalfunctionNov 24, 2021Decrease in Pressure; Decrease in Pressure
IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON GOT DEFLATED INSIDE THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12868917 ↗MalfunctionAug 30, 2021Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED THAT THE FOLEY CATHETER CAME OUT DUE TO BALLOON BURST. PER CUSTOMER VIA PHONE ON 08OCT2021, IT WAS STATED THAT BARD URINARY DRAIN BAG WAS LEAKING DUE TO PIN HOLE AND HAD ODOR, ALSO THE STEM WAS BROKEN AT THE CLAMP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12381848 ↗MalfunctionAug 26, 2021Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON BURST AND THE FOLEY CAME OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12370132 ↗MalfunctionAug 5, 2021Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT THE UROLOGIST WAS UNABLE TO DEFLATE THE BALLOON IN ORDER TO EXTRACT IT FROM THE FOOT. THE UROLOGIST SAID THE PATIENT NEVER WANTED TO USE BARD BRAND CATHETERS AGAIN. THE UROLOGIST KEPT THE OTHER CATHETER ON HAND, SO, THE PATIENT COULD NOT USED IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12283126 ↗
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.
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