Bard® Lubricath® Foley Catheter 365716Recalls & reported problems

Summary

The FDA's MAUDE database contains 117 adverse event reports that list this exact device (DI 00801741077746), received between May 19, 2017 and Jun 20, 2026 — classified as 26 injuries, 91 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (36 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 117 reports, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionMay 28, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT NURSE WAS SETTING UP FOLEY CATHETER, INFLATED BALLOON AND ATTEMPTED TO DEFLATE BUT BALLOON WOULD NOT DEFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19408820 ↗
• InjuryMay 14, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT WHEN ATTEMPTING TO REMOVE FOLEY NURSING STAFF WAS UNABLE TO DEFLATE BALLOON. UROLOGY WAS CALLED TO THE BEDSIDE AND WAS ABLE TO REMOVE BUT THIS CAUSED SIGNIFICANT TRAUMA TO THE URETHRA AND BLEEDING FROM THE MEATUS. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19309928 ↗
• MalfunctionApr 24, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT WHEN USING THE FOLEY CATHETER WAS NOT DEFLATING. THEY HAD THE PRODUCT FOR INVESTIGATION. THIS HAD BEEN GOING ON FOR A COUPLE WEEKS AND WAS NOT SURE IF THERE WAS PATIENT IMPACT. PCN #0165L16, PCN #365716 PER CUSTOMER FOLLOW UP RECEIVED ON 18APR2024, IT WAS REPORTED THAT THEY HAD ISSUES WITH DEFLATION FOR A 16FR. CATHETER PCN #0165L16 AND A FOLEY TRAY PCN #365716. NO PATIENTS WERE INVOLVED AND THE PRODUCT WAS TESTED BEFORE USE. THEY TRIED TO DEFLATE THE BALLOON AND IT WOULD NOT DEFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19170014 ↗
• MalfunctionFeb 28, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THEY HAVE BEEN INFORMED OF AN ISSUE WITH FOLEY BULBS NOT DEFLATING. THEY REQUESTED TO LET US KNOW IF THEY HAD KNOWLEDGE OF THIS ISSUE WITH ANY OTHER END USERS AND HOW THEY SHOULD PROCEED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18796398 ↗
• MalfunctionNov 14, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT 2 OF FOLEY CATHETERS WOULD NOT DEFLATE AFTER CUSTOMER INFLATED THEM. THE THIRD ONE THEY TRIED, DID. THEY WERE ALL FROM THE SAME LOT. THIS ITEM WAS BEING REPORTED BECAUSE OF THE BULB WHEN IT INFLATED WITH THE SOLUTION THEIR HAVING TROUBLE RETRACTING THE FLUIDS DURING THE DEFLATION PROCESS OF THIS PARTICULAR LOT SO FAR. ALSO, THIS ITEM ONLY WAS STOCKED IN L&D AND 3WA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18129993 ↗
• InjuryOct 26, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT FOLEY CATHETER PLACED PRE-OPERATIVELY, BALLOON FILLED WITH 10 ML OF SALINE FROM KIT. AS THE PHYSICIAN WAS PREPARING TO CLOSE THE FASCIA, A REQUEST FROM SAME OF BACK FILL THE BLADDER. NURSE PREPARED SOLUTION OF NORMAL SALINE AND METHYLENE BLUE (240 ML). THEY ATTACHED AND INTRODUCED 60 ML USING A LUER LOCK SYRINGE TO THE PORT ON THE DRAINAGE TUBE EASILY. THE SYRINGE REFILLED WITH 60 ML OF SOLUTION ATTACHED AND INTRODUCED SOLUTION, AFTER APPROXIMATELY 15 ML NURSE REPORTED RESISTANCE. SURGEON AND NURSE HEARD A "POP" SOUND. AT THIS TIME THERE WAS SUSPICION OF RUPTURE OF THE FOLEY BALLOON. FOLEY CATHETER REMOVED EASILY FROM URETHRA AND NOTED THE BALLOON NOT INFLATED AND APPEARED TO HAVE A PIECE MISSING AT THE SITE OF THE BALLOON. CYSTOSCOPE WAS NEEDED TO REMOVE A PIECE OF THE FOLEY. ALSO STATED THAT ADDITIONAL FLUID WAS INSTILLED TO THE BLADDER VIA SAMPLE PORT AND NOT TO THE BALLOON.

  Patient problems: Foreign Body In Patient

  MAUDE report 18011223 ↗
• MalfunctionOct 21, 2022Material Protrusion/Extrusion; Sharp Edges; Material Protrusion/Extrusion; Sharp Edges

  IT WAS REPORTED THAT THE FOLEY CATHETER WITH EXTRA PIECE AT TIP NOTED ON REMOVAL. PER SAMPLE RECEIVED ON (B)(6) 2022, IT WAS NOTED THAT THE RETURNED SAMPLE WAS PCN#(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15650351 ↗
• InjurySep 14, 2022Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THERE WAS A DETACHMENT OF DEVICE OR DEVICE COMPONENT. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 30AUG2022, STATED THAT THE BALLOON WAS LODGED IN PATIENT¿S URETHRA AND WAS UNABLE TO DEFLATE BALLOON. THE USER CONSULTED WITH UROLOGY AND WAS INSTRUCTED TO CUT THE CATHETER TO SEE IF BALLOON WOULD DEFLATE. STILL THE BALLOON WOULD NOT DEFLATE. PATIENT HAD TO HAVE NEEDLE ASPIRATION TO DEFLATE THE BALLOON.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15417720 ↗
• MalfunctionMay 9, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT HAD LEAKS AND ENDED UP GOING TO HOSPITAL FOR CHANGE OF FOLEY CATHETER. THE PATIENT REPORTED WRONG ITEM WAS SENT WITH THE ORDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14335931 ↗
• MalfunctionApr 19, 2022Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE BALLOON OF THE FOLEY CATHETER DID NOT INFLATE AT THE TIP OF THE CATHETER BUT IT SWELLED AT THE BASE INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14142097 ↗
• MalfunctionMar 3, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT HAS HAD MULTIPLE FOLEY CATHETER BALLOONS BURST FOR THE LAST 4-5 WEEKS. THERE WAS NO TYPE OF PATIENT HARM INVOLVED. PER FOLLOW-UP INFORMATION RECEIVED FROM IBC ON (B)(6) 2022, STATED THAT THERE HAVE BEEN 5 FOLEY CATHETERS IN A ROW THAT HAD THE BALLOON BURST AFTER INSERTION. TWO OF THE CATHETERS STAYED FOR 3 DAYS PRIOR TO BURSTING. AFTER THE LAST ONE BURST, LITTLE PIECES OF THE CATHETER WERE FOUND IN THE DIAPER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13661275 ↗
• MalfunctionFeb 10, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE PATIENT HAS HAD MULTIPLE FOLEY CATHETER BALLOONS BURST FOR THE LAST 4-5 WEEKS. THERE WAS NO TYPE OF PATIENT HARM INVOLVED. PER FOLLOW-UP INFORMATION RECEIVED FROM IBC ON 07FEB2022, STATED THAT THERE HAVE BEEN 5 FOLEY CATHETERS IN A ROW THAT HAD THE BALLOON BURST AFTER INSERTION. TWO OF THE CATHETERS STAYED FOR 3 DAYS PRIOR TO BURSTING. AFTER THE LAST ONE BURST, LITTLE PIECES OF THE CATHETER WERE FOUND IN THE DIAPER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13505586 ↗
• MalfunctionFeb 1, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE FOLEY CATHETER FELL OUT JUST AFTER THE INSERTION. THE USER NOTED THAT THE BALLOON HAD RUPTURED AND WAS ASSESSED WITH THE PHYSICIAN AND THERE WERE NO MISSING PIECES OF BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13419003 ↗
• MalfunctionJan 28, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE FOLEY CATHETER FELL OUT JUST AFTER THE INSERTION. THE USER NOTED THAT THE BALLOON HAD RUPTURED AND WAS ASSESSED WITH THE PHYSICIAN AND THERE WERE NO MISSING PIECES OF BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13389679 ↗
• InjuryDec 14, 2021Illegible Information; Illegible Information

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ALLERGIC REACTIONS WITH THE USE OF LATEX URINARY CATHETERS. IT WAS STATED THAT THE PATIENT REQUIRED SURGICAL AIRWAY DUE TO ALLERGIC REACTIONS. THE CUSTOMER REPORTED THAT UPON REVIEWING THEIR CURRENT MATERIALS, IT WAS APPARENT THAT THE LABELLING OF FOLEY KITS AND THE INDIVIDUAL CATHETERS, WITH RESPECT TO LATEX-STATUS HAD NOT BEEN AS EFFECTIVE AS THEY WISHED. IT WAS STATED THAT THE LATEX CAUTION LABEL WAS NOT EASILY VISIBLE, AND IT COULD BE DIFFICULT TO TELL THE DIFFERENCE BETWEEN LATEX AND LATEX-FREE KITS. ALSO STATED THAT THE INDIVIDUAL URINARY CATHETERS MIGHT ALSO CONTAIN LATEX.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 13004348 ↗