Bard Lubricath Foley CatheterRecalls & reported problems across all models
C. R. Bard, Inc. · 8 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 191
- Deaths reported
- 0
- Injuries reported
- 40
- Recalls
- 0
We found 8 models of Bard Lubricath Foley Catheter by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 191 adverse event reports in the FDA's MAUDE database, received between May 19, 2017 and Jun 20, 2026 — classified as 40 injuries, 151 malfunctions.
The most frequently reported specific device problem is “Deflation Problem” (54 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 Lubricath Foley Catheter problems
Device problems
- Deflation Problem54
- Difficult to Remove46
- Burst Container or Vessel42
- Material Rupture24
- Leak/Splash11
- Fluid/Blood Leak10
- Inaccurate Flow Rate9
- Inflation Problem8
Patient problems
- No Known Impact Or Consequence To Patient69
- No Clinical Signs, Symptoms or Conditions63
- No Consequences Or Impact To Patient60
- Pain14
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available13
- Patient Problem/Medical Problem12
- Discomfort11
- Foreign Body In Patient9
Bard Lubricath Foley Catheter models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Bard® Lubricath® Foley Catheter 365716CATHETER, COUDE117 reports
- Bard® Lubricath® Foley Catheter 365714CATHETER, COUDE42 reports
- Bard® Lubricath® Foley Catheter 365718CATHETER, COUDE18 reports
- Bard® Lubricath® Foley Catheter 365712CATHETER, COUDE4 reports
- Bard® Lubricath® Foley Catheter 366714CATHETER, UROLOGICAL4 reports
- Bard® Lubricath® Foley Catheter 365724CATHETER, COUDE3 reports
- Bard® Lubricath® Foley Catheter 366716CATHETER, UROLOGICAL2 reports
- Bard® Lubricath® Foley Catheter 365722CATHETER, COUDE1 report
Recent Bard Lubricath Foley Catheter adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJun 20, 2026Difficult to Remove
IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON NOT DEFLATING WITH SYRINGE AT PORT ON CATHETER TUBE. PATIENT PLACED IN MULTIPLE POSITIONS AND STILL UNABLE TO DEFLATE. FOLEY DRAINING ADEQUATE AMOUNTS THROUGHOUT SHIFT. REVIEWED WITH L&D "[LABOR AND DELIVERY]", SUGGESTION MADE TO CUT TUBING AT INFLATION PORT. PINK PORT CUT FROM CATHETER TUBE, SALINE DRAINED, AND CATHETER REMOVED WITHOUT DIFFICULTY. PATIENT BLADDER SCANNED POST REMOVAL FOR 29 CC. OB "[OBSTETRICIAN]" AWARE. OVER TO ASSESS PT. BEDSIDE US "[ULTRASOUND]" PERFORMED. THE PATIENT WAS POST C/S "[CESAREAN SECTION]" FROM THIS MORNING AT 0935. REGISTERED NURSE ATTEMPTED TO REMOVE HER FOLEY AS ORDERED AROUND 1830. PER REGISTERED NURSE, THE FOLEY HAD BEEN ADEQUATELY DRAINING ALL SHIFT. REGISTERED NURSE UNABLE TO DEFLATE THE FOLEY USING A 10CC SYRINGE AT THE PINK INFLATION PORT. REGISTERED NURSE MOVED THE PATIENT TO MULTIPLE DIFFERENT POSITIONS WITH NO LUCK. WHEN REGISTERED NURSE WENT OVER TO L&D ROUNDS, REGISTERED NURSE ASKED IF ANYONE HAD ENCOUNTERED THIS ISSUE BEFORE BECAUSE NONE OF US HAD EXPERIENCED THIS. L&D STATED THAT THEY SOMETIMES SEE IT PRIOR TO DELIVERY WHEN THE BABY'S HEAD WAS LOW AND THEY USUALLY CUT THE INFLATION PORT
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information
MAUDE report 25571638 ↗MalfunctionFeb 19, 2026Material Rupture
IT WAS REPORTED THAT THE FOLEY CATHETER BLEW UP IN THE MIDDLE OF THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions; Skin Inflammation/ Irritation
MAUDE report 24394225 ↗MalfunctionJan 30, 2026Material Rupture
IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON POPPED INSIDE PATIENT. PER FOLLOW UP INFORMATION RECEIVED ON 20FEB2026, IT WAS REPORTED PATIENT DID REQUIRE ANOTHER CATHETER INSERTION, OTHERWISE NO OTHER MEDICAL INTERVENTION REQUIRED. NO TROUBLESHOOTING WAS REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24226378 ↗MalfunctionJan 30, 2026Material Rupture
IT WAS REPORTED THAT A CATHETER INSERTED IN THE EMERGENCY DEPARTMENT MALFUNCTIONED. NURSING STAFF NOTED THAT THE FOLEY CATHETER WAS BYPASSING DURING THE DAY AND NIGHT. THE PATIENT REPORTED FEELING A ¿POP,¿ AFTER WHICH THE CATHETER SLIPPED OUT, AND THE BALLOON APPEARED VISIBLY BROKEN. THE CATHETER WAS PART OF A KIT/TRAY. NO HARM OCCURRED TO THE PATIENT. PHOTOS WERE TAKEN OF THE CATHETER, WITH TUBING NUMBERS 365714 AND 50N096 DOCUMENTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24221909 ↗MalfunctionNov 7, 2025Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT THERE WAS A FAILURE WHILE PLACING A FOLEY CATHETER. REGISTERED NURSE TESTED THE FOLEY BALLOON. REGISTERED NURSE NOTED IT WOULDN'T DEFLATE THE FLUID INSERTED. REGISTERED NURSE CALLED ANOTHER NURSE TO VERIFY. FOLEY CATHETER GIVEN TO MANAGEMENT. NO LOT NUMBER WAS RECORDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23498372 ↗MalfunctionNov 5, 2025Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT THERE WAS A FAILURE WHILE PLACING A FOLEY CATHETER. REGISTERED NURSE TESTED THE FOLEY BALLOON. REGISTERED NURSE NOTED IT WOULDN'T DEFLATE THE FLUID INSERTED. REGISTERED NURSE CALLED ANOTHER NURSE TO VERIFY. FOLEY CATHETER GIVEN TO MANAGEMENT. NO LOT NUMBER WAS RECORDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23479178 ↗MalfunctionJun 25, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT FOR 15 YEARS, THE USER HAD NO ISSUES USING A GREEN FOLEY CATHETER FROM THE COMPANY. RECENTLY, THEY RECEIVED A BROWN REPLACEMENT DUE TO SUPPLY ISSUES. AFTER ONE DAY, THE USER EXPERIENCED URINE AND FLUID LEAKAGE AND INFORMED THEIR MEDICAL TEAM. THE CATHETER WAS DIFFICULT AND PAINFUL TO REMOVE, WITH SMALL BUBBLES NOTED AT THE END.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22329805 ↗MalfunctionJun 25, 2025Difficult to Remove; Material Protrusion/Extrusion; Difficult to Remove; Material Protrusion/Extrusion
IT WAS REPORTED THAT FOR 15 YEARS, THE USER HAD NO ISSUES USING A GREEN FOLEY CATHETER FROM THE COMPANY. RECENTLY, THEY RECEIVED A BROWN REPLACEMENT DUE TO SUPPLY ISSUES. AFTER ONE DAY, THE USER EXPERIENCED URINE AND FLUID LEAKAGE AND INFORMED THEIR MEDICAL TEAM. THE CATHETER WAS DIFFICULT AND PAINFUL TO REMOVE, WITH SMALL BUBBLES NOTED AT THE END. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 10JUL2025, CUSTOMER STATED THEY ARE MAINTAINING THE CATHETER CURRENTLY IN A ZIPLOCK BAG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22328028 ↗MalfunctionFeb 14, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT THE BALLOON FROM THE FOLEY CATHETER POPPED INSIDE THEIR PATIENT. THIS HAPPENED TWICE. THERE WAS NO PATIENT HARM, AND THE CUSTOMER HAD THE DEFECTIVE PRODUCT TO RETURN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21383900 ↗MalfunctionFeb 10, 2025Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON WAS NOT DEFLATING. PER FOLLOW UP VIA EMAIL ON 07FEB2025. IT WAS REPORTED THAT THE PRODUCT CATALOG NUMBER WAS 0165L20 AND THE LOT NUMBER WAS NGJU2545. THE PATIENT WAS IDENTIFIED AS A FEMALE. THE CATHETER BROKE INSIDE THE PATIENT, BUT THE CATHETER CAME OUT OF THE PATIENT. THERE WAS NO HARM, BUT CATHETER WAS REPLACED. THE PATIENT CAME INTO THE CLINIC AND STATED THAT THE CATHETER HAD COME OUT DUE TO THE BALLOON POPPING. THE CUSTOMER WAS AT HOME WHEN IT HAPPENED AND THEN WENT TO THE EMERGENCY DEPARTMENT TO HAD IT REPLACED. THE PATIENT STATED THIS WAS THE SECOND TIME IT HAD HAPPENED AND WOULD NOT ALLOW STAFF TO USE THE SAME KIND OF CATHETER AGAIN. PATIENT BROUGHT THE CATHETER INTO THE CLINIC. CURRENTLY STAFF HAD IT IN MATERIALS READY TO GO OUT TO THE MANUFACTURER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21343310 ↗MalfunctionOct 14, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT THREE OF THE PATIENT'S CATHETERS HAD BURST. THEY HAD PRODUCT TO RETURN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20438726 ↗MalfunctionAug 23, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT PATIENT WAS UNABLE TO VOID POST-OP, PHYSICAN ORDERED FOLEY CATHETER INSERTION. NURSE OPENED ONE FOLEY CATHETER KIT AND CATHETER WAS MISSING (MW5157012). NO EXTRA FOLEY CATHETER WAS AVAILABLE IN DEPARTMENT, SO ANOTHER KIT WAS OPENED. NURSES DISCOVERED THE COVERING OF THE CATHETER WAS TORN OPENED (MW5157013). NURSES DECIDED TO OPEN A THIRD KIT AND AGAIN THE COVERING OVER THE CATHETER WAS TORN (MW5157011). HOUSE SUPERVISOR WAS NOTIFIED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20049895 ↗MalfunctionAug 23, 2024Inflation Problem; Inflation Problem
IT WAS REPORTED THAT DURING A FOLEY CATHETER INSERTION THE BALLON WOULD NOT INFLATE DUE TO RESISTANCE AFTER MULTIPLE ATTEMPTS. WHEN THE NURSE PUT MORE FORCE BEHIND THE ATTEMPT TO INFLATE THE BALLOON THE SYRINGE BLEW OFF SPRAYING THE WATER AROUND. THE DEFECTIVE CATHETER WAS REMOVED FROM THE PATIENT. THE PATIENT THEN HAD TO BE RE-CATHETERIZED WITH A NEW FOLEY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20049257 ↗MalfunctionAug 23, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT PATIENT WAS UNABLE TO VOID POST-OP, PHYSICAN ORDERED FOLEY CATHETER INSERTION. NURSE OPENED ONE FOLEY CATHETER KIT AND CATHETER WAS MISSING (MW5157012). NO EXTRA FOLEY CATHETER WAS AVAILABLE IN DEPARTMENT, SO ANOTHER KIT WAS OPENED. NURSES DISCOVERED THE COVERING OF THE CATHETER WAS TORN OPENED (MW5157013). NURSES DECIDED TO OPEN A THIRD KIT AND AGAIN THE COVERING OVER THE CATHETER WAS TORN (MW5157011). HOUSE SUPERVISOR WAS NOTIFIED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20048179 ↗InjuryMay 31, 2024Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT NURSING STAFF UNABLE TO FULLY DEFLATE FOLEY CATHETER BALLOON, UROLOGY WAS CONSULTED, AND CATHETER WAS REMOVED AND REPLACED WITH SECONDARY CATHETER, TRAUMA AND SIGNIFICANT URETHRAL BLEEDING WAS NOTED. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 19434467 ↗
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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