Bardex® Lubricath® Foley Catheter Tiemann Model Coude 0102L16Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 00801741018121), received between Feb 28, 2018 and Feb 3, 2026 — classified as 13 injuries, 45 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (11 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 58 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 3, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS INSERTED AND HAD URINE RETURN TO WHICH THAT REGISTERED NURSE INFLATED THE BALLOON OF THE CATHETER; HOWEVER, THE URINE FLOW THEN STOPPED. REGISTERED NURSE AND THE CHARGE REGISTERED NURSE MADE THE DECISION TO REMOVE THAT CATHETER, BUT WHEN THE CHARGE REGISTERED NURSE ATTEMPTED TO DEFLATE THE BALLOON, THE SYRINGE FILLED WITH 3ML OF PURE BLOOD. THE CATHETER WAS ABLE TO BE REMOVED FROM THE PATIENT SUCCESSFULLY AND REGISTERED NURSE AND THE CHARGE REGISTERED NURSE INSPECTED THAT TO FIND A HOLE MID WAY THROUGH THE CATHETER. THE PROVIDER WAS THEN NOTIFIED AND UROLOGY WAS CONSULTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24247500 ↗
• MalfunctionJan 23, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THEY RECEIVED A CALL FROM THE PATIENT'S DAUGHTER AND STATED THE FOLEY CATHETER ITEM 0102L16, SENT IN NOVEMBER WAS LEAKING WHEN IT WAS BEING USED, POTENTIALLY DUE TO A PRODUCT QUALITY, AND NEEDED TO BE CHANGED EARLY. THEY INDICATED THE ITEM INCLUDED ON PO 2377178 SENT IN DECEMBER DID NOT HAVE THE SAME PRODUCT QUALITY ISSUE. THEY DID NOT HAVE THE PACKAGING FOR EITHER CATHETER FOR A LOT NUMBER. ALSO ASKED, ARE THEY ABLE TO GET A REPLACEMENT QUANTITY 1 OF THE ITEM SENT OUT. THEY DON'T HAVE THE ITEM. NO REPLACEMENT IS NEEDED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24165207 ↗
• MalfunctionDec 4, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT WHEN WRITER WAS INSERTING FOLEY CATHETER, SAME WENT TO INFLATE BALLOON AND DESPITE NO RESISTANCE, THE END CAP OF THE BALLOON PORT FLEW OFF. SALINE ALL REMOVED FROM BALLOON AND REMOVED CATHETER AS IT WAS NO LONGER ABLE TO BE USED. NO ACTUAL HARM DONE TO PATIENT, BUT INCREASED RISKS TO PATIENT AS HAD TO HAVE ANOTHER CATHETER INSERTED. BALLOON ITSELF REMAINED INTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23723075 ↗
• MalfunctionNov 4, 2025Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT SAID HIS FOLEY WAS DEFECTIVE. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23467058 ↗
• MalfunctionNov 3, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT FOLEY CATHETER CAP ON INFLATION LUMEN CAME OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23452640 ↗
• InjuryJul 30, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT PATIENT PULLED FOLEY CATHETER OUT AND ONLY HALF CAME OUT, HAS A SURGERY SCHEDULED TO REMOVE THE OTHER HALF OF THE DEVICE. PATIENT HAD DEVICE IN FOR 20 DAYS WHEN THEY REMOVED IT, PATIENT HAS DEMENTIA. IT WAS NOTED THAT THE GIVEN LOT#NGJX0928. PER ADDITIONAL INFORMATION RECEIVED VIA MAIL ON 26AUG2025, IT WAS REPORTED THAT THE PRODUCT WAS SENT TO THE HOSPITAL. IT HAD TO BE SURGICALLY REMOVED BY CYSTOSCOPY.

  Patient problems: Foreign Body In Patient

  MAUDE report 22672147 ↗
• MalfunctionJul 30, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT FOLEY CATHETER WAS CHANGED WHEN CAP AT THE END POPPED OFF AND WAS ABLE TO SWITCH OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22665949 ↗
• MalfunctionJun 17, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT HAD FOLEY CATHETER IN PLACE AND STATES THE BALLOON FAILED ON THREE SEPARATE OCCASIONS. STATES IT SEEMED TO HAVE BEEN LEAKING FROM THE INFLATION PORT (SLIGHTLY DIFFERENT THAN THE PREVIOUS TWO TIMES). EXPLAINED THAT THIS ISN'T COMMON AND ISN'T SUPPOSED TO HAPPEN WHILE USING THE FOLEYS. PATIENT MENTIONED THE FIRST DAY OUT RUNNING ERRANDS WITH HIS CATHETER HE DID HAVE SLIGHT BLEEDING. INFORMED PATIENT HE WOULD NEED TO CONTACT HIS HCP FOR ASSISTANCE WITH THE COMPLICATIONS. BLEEDING COULD BE FROM DIFFERENT REASONS THAT THE MANUFACTURER CANNOT DETERMINE. DISCUSSED THE STATLOCK TO REDUCE PISTONING.

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

  MAUDE report 22234713 ↗
• MalfunctionMay 7, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE NURSE AND NURSING STUDENT ATTEMPTED TO INSERT FOLEY CATHETER INTO PATIENT DUE TO URINE RETENTION. AFTER NOT RECEIVING URINE RETURN WITH INSERTION THE NURSE CALLED IN WRITER TO ASSIST WITH INSERTION. WRITER TRIED REPOSITIONING THE CATHETER WITH NO RETURNS. FOLEY CATHETER REMOVED TO ATTEMPT WITH A NEW CATHETER. ONCE REMOVED WRITER AND ORIGINAL NURSE IDENTIFIED THAT THERE WERE NO DRAINAGE HOLES IN THE END OF THE CATHETER. NEW CATHETER INSERTED WITH NO COMPLICATIONS. UNIT NURSE EDUCATOR NOTIFIED OF SITUATION. FOLEY CATHETER WITH NO HOLES KEPT ON UNIT TO HELP WITH POSSIBLE MANUFACTURER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21977214 ↗
• MalfunctionMay 5, 2025Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT THE NURSE WAS ABLE TO INFLATE THE FOLEY CATHETER BALLOON BUT THEN UNABLE TO DEFLATE IT FOR REPOSITIONING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21960961 ↗
• InjuryMay 2, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON WOULD NOT DEFLATE WHEN THE REGISTERED NURSE ATTEMPTED TO CHANGE THE CATHETER. MULTIPLE ATTEMPTS TO REMEDY INCLUDED IRRIGATION. FINALLY, RESIDENT ADMITTED TO EMERGENCY ROOM WHERE PHYSICIANS ATTEMPTED REMOVAL WITH ULTRASOUND GUIDEWIRE TO NO EFFECT. REQUIRED TRANSFER TO RED DEER FOR REMOVAL BY UROLOGIST AND THE DEVICE WAS RETAINED.

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

  MAUDE report 21950208 ↗
• MalfunctionMay 2, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY CATHETER UPON FILLING THE BALLOON THEY NOTED A IT HAD A PIN HOLE AND WAS LEAKING OUT. THEY HAD TO REMOVE SAME AND REINSERT WITH NEW FOLEY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21950198 ↗
• MalfunctionApr 22, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THEY HAD INSERTED A FOLEY CATHETER THAT WAS NOT DRAINING ANY URINE AND UPON FURTHER INSPECTION, IT DID NOT HAVE ANY DRAINAGE HOLE IN THE TIP OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21882330 ↗
• MalfunctionApr 1, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO FOLEY CATHETERS ON OF WHICH HAD A SLOW LEAK FROM THE TOP AND THE SECOND THEY NOTED A SLIT IN THE LINING THAT ALLOWED LIQUID TO LEAK. THEY SAID IT WAS VERY DIFFICULT TO DEAL WITH FOR AN ENTIRE MONTH. STATED THEY RECEIVED A CALL FROM SOME GUY BUT DID NOT HAVE HIS NAME OR NUMBER. THEY STATED THEY PROBABLY GAVE THEM A CASE NUMBER BUT DIDN'T WRITE THAT DOWN EITHER. REPRESENTATIVE ADVISED CALLER THAT THE BEST BET TO RECEIVE A PROPER INVESTIGATION OF THIS COMPLAINT WOULD BE TO SPEAK WITH THE BD PRODUCT COMPLAINTS TEAM; AGREED. ATTEMPT TO TRANSFER AND THE TEAM WAS IN A MEETING. ADVISED CALLER OF THIS AND STATED THEY COULD SEND THEM AN EMAIL FOR FOLLOW UP AS WELL AS THEM LEAVING THEM A MESSAGE TO CALL BACK- BUT CALLER REFUSED AND STATED THEY WERE TIRED OF TALKING ABOUT IT. THEY DID STATE THAT THEY WERE UNSURE OF THE TIMELINE FOR THEIR (PC) TIMELINE FOR RESPONSE AND TO BE AWARE IT MAY NOT BE IMMEDIATE. PER CUSTOMER VIA PHONE ON 06MAY2025, IT WAS REPORTED, SAMPLE SENT BACK ON MAY 5TH, AWAIT SAMPLE TO EVALUATE AND HAVE REPLACEMENT SENT OUT IF NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21738448 ↗
• MalfunctionMar 27, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT TWO FOLEY CATHETERS ON OF WHICH HAD A SLOW LEAK FROM THE TOP AND THE SECOND THEY NOTED A SLIT IN THE LINING THAT ALLOWED LIQUID TO LEAK. THEY SAID IT WAS VERY DIFFICULT TO DEAL WITH FOR AN ENTIRE MONTH. STATED THEY RECEIVED A CALL FROM SOME GUY BUT DID NOT HAVE HIS NAME OR NUMBER. THEY STATED THEY PROBABLY GAVE THEM A CASE NUMBER BUT DIDN'T WRITE THAT DOWN EITHER. REPRESENTATIVE ADVISED CALLER THAT THE BEST BET TO RECEIVE A PROPER INVESTIGATION OF THIS COMPLAINT WOULD BE TO SPEAK WITH THE BD PRODUCT COMPLAINTS TEAM. AGREED. ATTEMPT TO TRANSFER AND THE TEAM WAS IN A MEETING. ADVISED CALLER OF THIS AND STATED THEY COULD SEND THEM AN EMAIL FOR FOLLOW UP AS WELL AS THEM LEAVING THEM A MESSAGE TO CALL BACK- BUT CALLER REFUSED AND STATED THEY WERE TIRED OF TALKING ABOUT IT. THEY DID STATE THAT THEY WERE UNSURE OF THE TIMELINE FOR THEIR (PC) TIMELINE FOR RESPONSE AND TO BE AWARE IT MAY NOT BE IMMEDIATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21707836 ↗
• MalfunctionFeb 14, 2025Component Misassembled; Component Misassembled

  THE UROLOGY PATIENT WITH A STANDING PRESCRIPTION FOR MONTHLY FOLEY CATHETERS, WHICH THEY INSERT THEMSELVES WITH PERMISSION OF THEIR DOCTOR AND HAD BEEN USING THE BARD ITEM 0102L16 FOR ABOUT THREE YEARS AND GET THEM FROM NORCO MEDICAL SUPPLY COMPANY. THREE OF THE CATHETERS HAD BEEN DEFECTIVE, TWO WITH A SLOW LEAK AT THE FUNNEL END. THE CUSTOMER USED THEM WITH THE BARD FLIP-FLO VALVE (BFF20), ALSO THOUGHT IT MIGHT BE THE VALVE THAT WAS THE PROBLEM, BUT WHEN REPLACED THE VALVE, THE LEAK CONTINUED. THE CUSTOMER DETERMINED THAT IT WAS NOT FROM THE END OF THE VALVE BUT FROM THE FUNNEL END OF THE CATHETER WHERE IT FITTED OVER THE VALVE STEM AND THOUGHT IT MUST HAVE BEEN A ONE-IN-A-MILLION DEFECT, BUT THEN IT HAPPENED AGAIN WITH ANOTHER CATHETER. WHEN THE REPLACED THAT ONE AND KEPT IT TO EXAMINE THE FUNNEL END AND SAW THAT THERE WAS A VERTICAL SLIT IN THE WHITISH LINING MATERIAL THAT ALLOWED THE LEAKAGE. IT WAS MISERABLE HAVING TO CONTEND WITH SEEPAGE FOR A MONTH (MEDICARE ONLY ALLOWS ONE CATHETER PER MONTH). THERE WAS OBVIOUSLY SOMETHING WRONG WITH THE MANUFACTURING AND QUALITY-CONTROL PROCESSES AT BARD. THE CUSTOMER REQUESTED THE CUSTOMER LOOK INTO THIS AND THAT THE REPLACE THE TWO DEFEC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21385196 ↗
• MalfunctionFeb 14, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE FOLEY RECEIVED FROM THE SUPPLIER HAD A DEFECTIVE TIP; SPECIFICALLY, THERE WAS A SLIT IN THE MATERIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21384650 ↗
• MalfunctionFeb 14, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  THE UROLOGY PATIENT WITH A STANDING PRESCRIPTION FOR MONTHLY FOLEY CATHETERS, WHICH THEY INSERT THEMSELVES WITH PERMISSION OF THEIR DOCTOR AND HAD BEEN USING THE BARD ITEM 0102L16 FOR ABOUT THREE YEARS AND GET THEM FROM NORCO MEDICAL SUPPLY COMPANY. THREE OF THE CATHETERS HAD BEEN DEFECTIVE, TWO WITH A SLOW LEAK AT THE FUNNEL END. THE CUSTOMER USED THEM WITH THE BARD FLIP-FLO VALVE (BFF20), ALSO THOUGHT IT MIGHT BE THE VALVE THAT WAS THE PROBLEM, BUT WHEN REPLACED THE VALVE, THE LEAK CONTINUED. THE CUSTOMER DETERMINED THAT IT WAS NOT FROM THE END OF THE VALVE BUT FROM THE FUNNEL END OF THE CATHETER WHERE IT FITTED OVER THE VALVE STEM AND THOUGHT IT MUST HAVE BEEN A ONE-IN-A-MILLION DEFECT, BUT THEN IT HAPPENED AGAIN WITH ANOTHER CATHETER. WHEN THE REPLACED THAT ONE AND KEPT IT TO EXAMINE THE FUNNEL END AND SAW THAT THERE WAS A VERTICAL SLIT IN THE WHITISH LINING MATERIAL THAT ALLOWED THE LEAKAGE. IT WAS MISERABLE HAVING TO CONTEND WITH SEEPAGE FOR A MONTH (MEDICARE ONLY ALLOWS ONE CATHETER PER MONTH). THERE WAS OBVIOUSLY SOMETHING WRONG WITH THE MANUFACTURING AND QUALITY-CONTROL PROCESSES AT BARD. THE CUSTOMER REQUESTED THE CUSTOMER LOOK INTO THIS AND THAT THE REPLACE THE TWO DEFEC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21384108 ↗
• MalfunctionJan 24, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE COUDE FOLEY CATHETER CUSTOMER WAS USING DID NOT COMPLETELY SEAL, CAUSING CONSTANT SEEPAGE FOR THE ENTIRE MONTH. HAD TO USE TWO AND ONLY RECEIVED ONE PER MONTH. PER CUSTOMER VIA PHONE ON 28JAN2025, IT WAS REPORTED, HE WAS TOLD SOMEONE WILL BE CALLING HIM TO HELP TROUBLESHOOT THE ISSUES REPORTED OF THE COUDE FOLEY CATHETER CUSTOMER WAS USING DID NOT COMPLETELY SEAL, CAUSING CONSTANT SEEPAGE FOR THE ENTIRE MONTH. HAD TO USE TWO AND ONLY RECEIVED ONE PER MONTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21228619 ↗
• MalfunctionJan 22, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUSTOMER WOULD LIKE TO COMPLETE A PRODUCT COMPLAINT FORM FOR 16 FR COUDE INTERMITTENT CATHETER. PER CUSTOMER FOLLOW UP ON 07JAN2025, IT WAS REPORTED THAT CUSTOMER WAS UNABLE TO INFLATE BALLOON OF FOLEY CATHETER DURING THE CATHETERIZATION. LOT NUMBER OF THE REPORTED DEVICE WAS NGHY2945. ANOTHER FOLEY WAS INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21209492 ↗
• MalfunctionMay 7, 2024Calcified; Calcified

  IT WAS REPORTED THAT THE FOLEY CATHETER SOMETIMES CLOGGED DUE TO CALCIUM DEPOSITS AND HAD DISCUSSED THIS WITH DOCTOR. PATIENT WAS INTERESTED IN 2 FOLEYS SINCE THEY DID NOT RECEIVE AN ORDER SINCE INITIAL ORDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19260442 ↗
• InjuryMay 6, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT HAD BLADDER INFECTION WHILE USING FOLEY CATHETER AND ALSO STATED RESULTING IN HOSPITALIZATION TWICE. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 19250385 ↗
• InjuryMar 8, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THEY HAD AN ISSUE WITH DEFLATING FOLEY CATHETER AT THE END OF THE SURGERY. THE CATHETER WAS PLACED AT THE BEGINNING OF THE CASE AND WOULD NOT DEFLATE. PHYSICIAN HAD TO USE A LASER TO PUNCTURE THE BALLOON IN ORDER TO DEFLATE AND REMOVE FROM PATIENT. LOT# NGHW0803, LOT# NGHW2914.

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

  MAUDE report 18866122 ↗
• InjuryMar 8, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THEY HAD AN ISSUE WITH DEFLATING CATHETER AT THE END OF THE SURGERY. THE CATHETER WAS PLACED AT THE BEGINNING OF THE CASE AND WOULD NOT DEFLATE. PHYSICIAN HAD TO USE A LASER TO PUNCTURE THE BALLOON IN ORDER TO DEFLATE AND REMOVE FROM PATIENT. LOT#NGHW0803, LOT# NGHW2914.

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

  MAUDE report 18866121 ↗
• InjuryMar 1, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS PUT IN PLACE, THE BALLOON WAS FILLED AND THE PROCEDURE THAT NEED TO TAKE PLACE WAS COMPLETED. ONCE COMPLETE WITH THE PROCEDURE, THE ATTENDING STAFF WENT THROUGH THE PROCESS OF DEFLATING THE BALLOON AND THE BALLOON WOULD NOT DEFLATE. THE DOCTOR TRIED CUTTING THE END OF THE CATHETER TO SEE IF BALLOON WOULD DEFLATE SO THEY COULD PULL THE CATHETER OUT AND IT DID NOT. AT THAT POINT, IN ORDER TO GET THE CATHETER TO DEFLATE, THE DOCTOR USED A LASER TO PUNCTURE THE BALLOON WHICH ALLOWED IT TO DEFLATE AND THEY WERE ABLE TO PULL IT OUT. THEY ASKED FOR ALL PRODUCT TO BE REMOVED AND AN IRIS WRITTEN FOR THE INCIDENT AND HAD REMOVED ALL OF THE PRODUCT FROM SHORT STAY (16 EA.) AND HAVE THEM IN THEIR OFFICE. THERE WERE 2 DIFFERENT LOT NUMBERS. THERE WERE A QUANTITY OF 11 WITH LOT NUMBER (LOT #NGHW0803) AND A QUANTITY OF 5 WITH LOT NUMBER (LOT #NGHW2914).

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

  MAUDE report 18815503 ↗