Bard® Touchless® Plus Unisex Pre-Lubricated Vinyl Urethral Catheter Kit 4A5108Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00801741030567), received between May 2, 2017 and Oct 27, 2025 — classified as 3 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (13 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT TOUCHLESS INTERMITTENT CATHETER WAS BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23394019 ↗
• MalfunctionAug 8, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT CUSTOMER HAD 13 INTERMITTENT CATHETER CRUSHED TIPS AND 14 WERE UNUSABLE BECAUSE THEY WERE EXCESSIVELY COATED WITH GEL, PREVENTING URINE FROM FLEW OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22755337 ↗
• MalfunctionAug 8, 2025Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT CUSTOMER HAD 13 INTERMITTENT CATHETER CRUSHED TIPS AND 14 WERE UNUSABLE BECAUSE THEY WERE EXCESSIVELY COATED WITH GEL, PREVENTING URINE FROM FLEW OUT. PER CUSTOMER EMAIL RESPONSE RECEIVED ON 20OCT2025. SAMPLE WAS AVAILABLE. PENDING SAMPLE RETURN. THE CATHETER WITH A LOT OF GEL ON IT WAS FOUND TO BE DEFECTIVE BECAUSE NO URINE CAME OUT DURING USE. THE ONE WITH THE BENT TIP WAS NOTICED TO BE DEFECTIVE BEFORE USE. WHILE USING THE CATHETER ON (B)(6) PATIENT SUSTAINED AN INJURY AND PASSED A LARGE AMOUNT OF BLOOD IN URINE. AFTER THAT, PATIENT DEVELOPED A URINARY TRACT INFECTION (UTI), WHICH PROGRESSED TO SEPSIS, AND WAS HOSPITALIZED FOR 5 DAYS FOR TREATMENT OF ANTIBIOTICS. PATIENT ADVISED TO PLEASE MAKE A SOFT CATHETER TO AVOID INJURING THE URETHRA. ALSO ADVISED TO PLEASE APPLY ONLY A SMALL AMOUNT OF GEL WHEN MAKING IT. IF THE CATHETER WAS DEFECTIVE, PATIENT HAD TO CATHETERIZE TWICE IN A ROW, WHICH INCREASES THE RISK OF GETTING A URINARY TRACT INFECTION. PER NOTIFICATION FROM INVESTIGATOR ON 31MAR2026 IT WAS REPORTED THAT THE THE KINK/BEND IN THE TIP AND ANOTHER EXCESSIVE LUBRICIOUS PRESENTED WAS FOUND DURING SAMPLE EVALUATION ON 30MAR2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22755335 ↗
• MalfunctionApr 23, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE JELLY WAS EXCESSIVELY APPLIED TO THE INTERMITTENT CATHETER TUBE, CAUSING BLOCKAGES THAT PREVENTED URINE FROM FLOWING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21892334 ↗
• MalfunctionNov 21, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE ISSUES INCLUDE TOUCH LESS INTERMITTENT CATHETER TIPS BENT LIKE UMBRELLA HANDLES OR EXCESSIVE GEL INSIDE THE CATHETER TUBE, PREVENTING URINE FLOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20745870 ↗
• InjuryNov 21, 2024Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE ISSUES INCLUDE TOUCH LESS INTERMITTENT CATHETER TIPS BENT LIKE UMBRELLA HANDLES OR EXCESSIVE GEL INSIDE THE CATHETER TUBE, PREVENTING URINE FLOW. PER ADDITIONAL INFORMATION RECEIVED ON 28OCT2024, THE CUSTOMER HAD ENCOUNTERED 36 DEFECTIVE CATHETERS. THE ISSUES INCLUDE CATHETER TIPS BENT LIKE UMBRELLA HANDLES OR EXCESSIVE GEL INSIDE THE CATHETER TUBE, PREVENTING URINE FLOW. PER ADDITIONAL INFORMATION RECEIVED ON 29OCT2024, THE 36 DEFECTIVE ITEMS, THEY SENT IN THE PREVIOUS EMAIL WERE COLLECTED FROM JULY TO THE PRESENT, WITH MANY DEFECTS COMING FROM LOT NUMBER: NGJR2350, WHICH HAS AN EXPIRATION DATE OF 28FEB2026. ADDITIONALLY, THE BOXES WERE NOT DAMAGED. THE TOTAL NUMBER OF DEFECTIVE ITEMS COLLECTED SO FAR WAS 36. PER ADDITIONAL INFORMATION RECEIVED ON 09NOV2024, THE CUSTOMER RECEIVED THE 36 ITEMS WELL. THE LOT NUMBER IS NGJU0708, WHICH WAS DIFFERENT FROM THE PREVIOUS ONE. THE HOPE THERE WERE NO DEFECTIVE PRODUCTS THIS TIME. ALSO, WOULD LIKE TO TRY OTHER PRODUCTS BESIDES BARD. PER FOLLOW UP VIA PHONE ON 17DEC2024, THE ISSUE WITH THE ITEM, THE ISSUES INCLUDE CATHETER TIPS BENT LIKE UMBRELLA HANDLES OR EXCESSIVE GEL INSIDE THE CATHETER TUBE, PREVENTING URINE FLOW

  Patient problems: No Clinical Signs, Symptoms or Conditions; Urinary Tract Infection

  MAUDE report 20745660 ↗
• MalfunctionMar 5, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE CUSTOMER HAD ISSUES THAT WERE FOUND WITH BARD 8 FR CATHETER KITS OVER THE LAST TWO DAYS. PER NIGHT SHIFT, TWICE A BRAND NEW CATHETER KIT WAS OPENED, REMOVED THE CAP TO THE TIP OF THE CATHETER AND THE TIP OF THE STRAIGHT CATHETER WAS BENT AT A 90 DEGREE ANGLE. IT WAS UNABLE TO PERFORM STRAIGHT CATCHING DUE TO CATHETER TIP NOT BEING STRAIGHT. DAY SHIFT NURSE ALSO REPORTED FINDING A SINGLE 8 FR STRAIGHT CATHETER KIT IN WHICH THE TIP WAS BENT AT A 90 DEGREE ANGLE AND WAS UNABLE TO USE CATHETER KIT AS IT WAS UNSAFE TO DO SO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18837197 ↗
• MalfunctionMay 23, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE CATHETER TUBING KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16986385 ↗
• MalfunctionFeb 7, 2023Component Missing; Component Missing

  IT WAS REPORTED THAT THE CUSTOMER HAD ISSUE WITH INDWELLING CATHETER. IT WAS STATED THAT THE CATHETER WAS PLACED ON 9MONTHS FEMALE IN OPERATING ROOM ON (B)(6) AND REMOVED ON (B)(6) BY A BEDSIDE NURSE. DOCUMENTATION STATED THE CATHETER WAS 6FR FILLED WITH 3CC AND TOOK 2 ATTEMPTS. UPON REMOVING NURSE DEFLATED THE BULB PASSIVELY AND GOT 3CC BACK, WHEN ATTEMPTED TO PULL THE CATHETER NURSE MET RESISTANCE. WHEN THE CATHETER WAS REMOVED IT WAS NOTED THAT THE BULB HAD FOLDED BACK AND HAD FORMED A RIDGE. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 24DEC2022, NO MEDICAL INTERVENTION WAS REQUIRED. PER FOLLOW-UP VIA EMAIL ON 17JAN2023, THE CUSTOMER HAD ANOTHER ISSUE WITH AN INDWELLING CATHETER ON (B)(6). THE NURSE PLACED AN IN-AND-OUT CATHETER (THE ONE WITH A BAG ATTACHED) TO OBTAIN A SPECIMEN AND RELIEVE BLADDER PRESSURE. APPROXIMATELY 700 CC OF URINE WERE RETURNED. UPON TRYING TO REMOVE THE CATHETER, RESISTANCE WAS FELT, SO THE BEDSIDE NURSE STOPPED AND CALLED THEM. THEY TRIED PUSHING THE CATHETER BACK IN (WITHOUT RESISTANCE) AND APPLIED MORE LUBRICATION BUT WERE NOT ABLE TO REMOVE THE CATHETER, SO THE PHYSICIAN TEAM WAS NOTIFIED, UROLOGY WAS CONSULTED, AND THEY CAME TO THE BEDSIDE AND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16312031 ↗
• MalfunctionJul 29, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT BARD TOUCHLESS PLUS UNISEX PRE-LUBRICATED INTERMITTENT CATHETER WAS NOTED TO HAVE BENT TIPS AND THIS SHIFT WAS NOTED TWICE. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15135685 ↗
• MalfunctionJun 23, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE INTERMITTENT CATHETERS WERE BENT UP AND WAS UNABLE TO USE THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14792787 ↗
• MalfunctionJun 21, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE INTERMITTENT CATHETERS WERE BENT UP AT LEAST 30 TO 40 OF THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14757936 ↗
• MalfunctionFeb 14, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THERE ARE ABOUT 10 DEFECTIVE TOUCH LESS INTERMITTENT CATHETER IN EVERY BOX. IT WAS STATED THAT THE TIP OF THE TOUCH LESS INTERMITTENT CATHETER WAS BENT, AND THE PATIENT COULD NOT USE. THE PATIENT STATED THAT SOME OF THE TOUCH LESS INTERMITTENT CATHETERS WERE BENT. IT WAS NOTED THAT THE PATIENT HAD BEEN USING THESE PRODUCTS MORE THAN 90 DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13524445 ↗
• MalfunctionSep 10, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE SOME OF THE TOUCH LESS INTERMITTENT CATHETERS WERE BENT. PATIENT HAD BEEN USING THE PRODUCT FOR MORE THAN 90 DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12453196 ↗
• MalfunctionMar 23, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE TOUCH LESS 8FR INTERMITTENT CATHETER WAS BENT. 4 OTHER KITS WERE REPORTED ON LAST MONTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11553831 ↗
• MalfunctionMar 4, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE TOUCH LESS INTERMITTENT KITS WERE COMPLETELY BENT LIKE A FISHHOOK. THE TWO KITS WERE THROWN AWAY BECAUSE OF BENT AND DID NOT COME OUT AND THE GLOVES WERE UNDERNEATH THE DRAPES WHICH MUST BE ON TOP TO KEEP THE STERILE FIELD. THE QUALITY CONTROL WITHIN THE KITS WERE JUST THROWN INTO THE PACKAGE NOT VERY CONDUCIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11418549 ↗
• MalfunctionNov 18, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE CATHETER REMOVED FROM BARD TOUCHLESS PLUS UNISEX, PRE-LUBRICATED URETHRAL CATH KIT (8FR) AND ONE OTHER KIT FROM THE SAME LOT NUMBER WAS BENT AT THE TIP AND WERE UNABLE TO BE USED FOR PATIENT CARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10863796 ↗
• MalfunctionOct 20, 2020Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE INTERMITTENT URETHRAL CATHETER WAS BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10703604 ↗
• MalfunctionAug 7, 2020Material Twisted/Bent

  IT WAS REPORTED THAT THERE WAS A BEND AT THE TIP OF THE CATHETER, WHICH CAUSED NO URINE CAME OUT WHEN THE PATIENT INSERTED THE CATHETER.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10382133 ↗
• InjuryApr 1, 2020Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT'S MOTHER SAID THE PATIENT HAS A UTI, ALTHOUGH SHE DIDN¿T SPECIFY IT WAS THE CATHETERS THAT CAUSED THE UTI. IT IS UNKNOWN IF THE PATIENT RECEIVED MEDICAL INTERVENTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 9914003 ↗
• InjuryNov 6, 2018Component Missing

  IT WAS REPORTED THAT THE PATIENT USED A CATHETER TRAY THAT DID NOT CONTAIN THE PVI (POVIDONE IODINE) SWAP STICKS AND ALLEGEDLY EXPERIENCED A UTI (URINARY TRACT INFECTION). THE PATIENT WAS TREATED WITH ANTIBIOTICS.

  Patient problems: Urinary Tract Infection

  MAUDE report 8042675 ↗
• MalfunctionSep 11, 2017Kinked

  IT WAS REPORTED THAT THE DRAIN BAG TUBING BECAME KINKED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6855117 ↗
• MalfunctionMay 2, 2017Bent

  IT WAS REPORTED THAT THE CATHETER TIP WAS BENT AND COULD NOT BE USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6539055 ↗