Bard® Touchless® Plus Unisex Pre-Lubricated Vinyl Coude Urethral Catheter Kit 4A7114Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741046452), received between Jun 12, 2019 and Apr 8, 2025 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (3 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2025Gel Leak; Gel Leak

  IT WAS REPORTED THAT THE AUTH CALLED TO SAY THAT THEY RECEIVED 10 THAT THE IODINE LEAKED INTO THE KIT. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21797808 ↗
• MalfunctionJan 27, 2023Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE PATIENT NOTICED THE INTERMITTENT CATHETERS HAD LESS LUBE IN THIS LAST SHIPMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16253973 ↗
• MalfunctionAug 19, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE BARD URETERAL CATHETER KIT HAD ISSUES WITH KINKING AND SCRUNCHING TOO TIGHT, HURTING THE INSIDE WHILE IN USE. THE PATIENT HAD BEEN USING IT FOR 3 MONTHS. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Pain

  MAUDE report 15258441 ↗
• MalfunctionAug 17, 2022Component Missing; Component Misassembled; Component Missing; Component Misassembled

  IT WAS REPORTED THAT CUSTOMER RECEIVED THE INTERMITTENT CATHETER KITS WITHOUT THE 14FR VINYL CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15240223 ↗
• MalfunctionAug 16, 2022Component Missing; Component Misassembled; Component Missing; Component Misassembled

  IT WAS REPORTED THAT THERE WERE NO TOUCH LESS PLUS COUDE CATHETERS IN THE KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15233564 ↗
• MalfunctionAug 1, 2022Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE INTERMITTENT CATHETERS WERE NOT COLLECTING AS MUCH URINE IN LAST THREE OR FOUR DAYS AS THEY NORMALLY DID, SO IT CAUSING LEAKAGE. CUSTOMER WOULD LIKE ASSISTANCE WITH TROUBLESHOOTING AND CUSTOMER WAS UP ALL NIGHT SO WOULD LIKE SOMEONE TO CONTACT LATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15139136 ↗
• MalfunctionJul 1, 2022Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE INTERMITTENT CATHETERS WERE NOT THE SAME SIZES SOMETIMES THEY WERE SMALLER AND KINK UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14887725 ↗
• MalfunctionJul 1, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE INTERMITTENT CATHETERS WERE NOT THE SAME SIZES SOMETIMES THEY WERE SMALLER AND KINK UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14886680 ↗
• MalfunctionApr 8, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TOUCHLESS INTERMITTENT CATHETER WAS LEAKING FROM THE BOTTOM OF THE BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14052070 ↗
• MalfunctionAug 24, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE PATIENT WAS USING THESE BARD VINYL COUDE URETHRAL CATHETER KITS DUE TO URINARY TRACT INFECTIONS AND THEIR COMPLAINT WAS THAT THE CATHETER DID NOT HAD A LINE ON IT SO THE PATIENT COULD KEEP THE TIP UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12357386 ↗
• InjuryFeb 16, 2021Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT USED THE TOUCHLESS CATHETER BUT COULD NOT REMOVE IT FROM URETHRA. PATIENT WENT TO THE EMERGENCY ROOM AND WAITING FOR FOUR AND HALF HOURS BUT WAS NOT SEEN SO LEFT AND WENT HOME BECAUSE PATIENT WAS TOO UNCOMFORTABLE DUE TO ACCIDENT INJURIES AND WAS UNABLE TO VOID THE NEXT DAY AND WENT TO SEE THE UROLOGIST. ALSO STATED THE UROLOGIST WAS UNABLE TO REMOVE THE CATHETER AND PATIENT HAD TO HAVE THE CATHETER SURGICALLY REMOVED. PATIENT'S URETHRA WAS TORN AND THE SURGEON DETERMINED THE CATHETER WAS BENT, AND THAT¿S WHY THE PATIENT WAS UNABLE TO REMOVE IT WITHOUT SURGERY. PATIENT WAS PLACED ON A FOLEY FOR SEVERAL WEEKS. THE SURGEON COULD NOT DETERMINE HOW THE CATHETER GOT BENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; No Code Available; Tissue Breakdown

  MAUDE report 11333937 ↗
• MalfunctionJun 12, 2019Difficult to Insert

  IT WAS REPORTED THAT THE CATHETERS WERE DIFFICULT TO INSERT AND CAUSED THE PAIN DURING INSERTION OF THE DEVICE. NO MEDICAL INTERVENTION REPORTED.

  Patient problems: Pain

  MAUDE report 8692025 ↗