Bard® Touchless® Plus Unisex Pre-Lubricated Vinyl Urethral Catheter 4A6144Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00801741030604), received between Apr 21, 2017 and Feb 11, 2026 — classified as 2 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Improper Chemical Reaction” (9 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 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2026Incorrect Measurement

  IT WAS REPORTED THAT THE CUSTOMER CALLED TO REPORT THAT INTERMITTENT CATHETER (PRODUCT 4A6044) HAD AN ISSUE WITH THE RUBBER AND THE INTERMITTENT CATHETER (PRODUCT 4A6144) WAS SMALLER THAN EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24314936 ↗
• MalfunctionMar 28, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT CUSTOMER HAD BEEN USING THESE INTERMITTENT CATHETERS FOR YEARS. THEY USED TO HAVE TOO MUCH GEL, BUT NOW THERE WAS TOO LITTLE. CUSTOMER WAS NOT SURE WHAT HAPPENED, BUT SOMETIMES CATHETERS WERE HARD TO INSERT ALL THE WAY IN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21721834 ↗
• MalfunctionFeb 21, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT ALL INTERMITTENT CATHETERS WERE DRIED, AND NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21432950 ↗
• MalfunctionNov 6, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THERE WAS NO LUBE ON THE LAST BATCH OF INTERMITTENT CATHETERS THAT CUSTOMER RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20621672 ↗
• MalfunctionSep 4, 2024Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT INTERMITTENT CATHETERS WERE COMING OUT OF THE BAG AND THE PATIENT WAS GETTING SOAKED. BE GOING ON FOR THE LAST 3 MONTHS CUSTOMER HAD 200 OF THEM THAT THEY DID NOT WANT TO USE ANYMORE AND HAS SAMPLES AVAILABLE FOR THE INVESTIGATION. PER CUSTOMER FOLLOW UP RECEIVED ON 10AUG2024, IT WAS REPORTED THAT THEY WERE EXPERIENCING ISSUES WITH THEIR CATHETERS COMING OFF WHILE THEY WERE URINATING. CUSTOMER STATED THAT THEY HAD BEEN USING THE CATHETERS FOR 30 YEARS AND THE DESIGN HAD CHANGED. CUSTOMER DESCRIBED THAT THE CATHETERS COME OFF MID-STREAM AND THEY HAD TO RUSH TO THE RESTROOM BECAUSE THEY KNEW IT WOULD CAUSE A BIG MESS. CUSTOMER STATED THAT THE END OF THE CATHETER WAS SUPPOSED TO GRADUALLY GET SMALLER, AND IT DIDN'T. THIS CAUSES THE CATHETER TO COME RIGHT OFF. REPORTED LOT WAS CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20134352 ↗
• MalfunctionMar 22, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT INTERMITTENT CATHETERS DID NOT HAVE HOLES IN IT. PER FOLLOW UP VIA PHONE ON 13MAR2024, IT WAS REPORTED THAT CUSTOMER KEPT RECEIVED CATHETERS WITH NO HOLES AND THEY NEED THEM TO BE REPLACED. CUSTOMER PURCHASED THE CATHETERS FROM BARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18958192 ↗
• MalfunctionJun 14, 2022Disconnection; Nonstandard Device; Disconnection; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT HAD TO BE VERY CAREFUL WHILE USING THE TOUCHLESS PLUS CATHETER IF NOT THEY FELL APART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14686882 ↗
• MalfunctionSep 14, 2021Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE INTERMITTENT CATHETERS EYELETS WERE ROUGH NOW. PATIENT HAD BEEN SO IRRITATED BY THE CATHETERS BECAUSE IT HAD CAUSED BLOOD AND THE PATIENT HAD TO GO TO THE DOCTOR. ALSO, PATIENT STATED THAT THE CATHETERS WERE ABOUT AN INCH SHORTER NOW AND MOST OF TIME THE LUBRICATION WAS DRIED UP. PATIENT HAD BEEN USING THE PRODUCT FOR MORE THAN 90 DAYS. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12468311 ↗
• MalfunctionSep 14, 2021Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE INTERMITTENT CATHETERS EYELETS WERE ROUGH NOW. PATIENT HAD BEEN SO IRRITATED BY THE CATHETERS BECAUSE IT HAD CAUSED BLOOD AND THE PATIENT HAD TO GO TO THE DOCTOR. ALSO, PATIENT STATED THAT THE CATHETERS WERE ABOUT AN INCH SHORTER NOW AND MOST OF TIME THE LUBRICATION WAS DRIED UP. PATIENT HAD BEEN USING THE PRODUCT FOR MORE THAN 90 DAYS. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 12468304 ↗
• MalfunctionSep 14, 2021Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE INTERMITTENT CATHETERS EYELETS WERE ROUGH NOW. PATIENT HAD BEEN SO IRRITATED BY THE CATHETERS BECAUSE IT HAD CAUSED BLOOD AND THE PATIENT HAD TO GO TO THE DOCTOR. ALSO, PATIENT STATED THAT THE CATHETERS WERE ABOUT AN INCH SHORTER NOW AND MOST OF TIME THE LUBRICATION WAS DRIED UP. PATIENT HAD BEEN USING THE PRODUCT FOR MORE THAN 90 DAYS. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12468296 ↗
• MalfunctionAug 6, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT ONE IN EVERY 40 INTERMITTENT CATHETERS HAD A KINK IN IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12286024 ↗
• MalfunctionJun 29, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT INTERMITTENT CATHETER HAD THE HOLES IN THE TIP OF THE CATHETERS AND NOT BEEN FULLY PUNCHED OUT WHICH LEAVES A FLAP THAT DRAGS ALONG THE INSIDE OF THE URETHRA. CUSTOMER EXPERIENCED IRRITATION IN THE URETHRA AND PROBLEMS WITH URINATION. NO MEDICAL INTERVENTION WAS REPORTED. PER FOLLOW UP ON 10MAY2021, PATIENT HAD AMOUNT OF BLEEDING, INCONTINENCE AND BURNING. PATIENT NOT USED ONE OF THE DEFECTIVE CATHETERS IN ALMOST A WEEK NOW. NO MEDICAL INTERVENTION WAS REPORTED. PER FOLLOW UP ON 02JUN2021, THE NEW SHIPMENT HAD A NUMBER OF CATHETERS THAT WERE CRIMPED AND ALMOST CLOSED. WHILE INSERTING THE CATHETER SOMETIMES IT GETS DOUBLED OVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12089689 ↗
• MalfunctionMay 27, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE INTERMITTENT CATHETERS HAD HOLES IN THE TIP OF THE CATHETERS AND WERE NOT FULLY PUNCHED OUT WHICH LEAVES A FLAP THAT DRAGS ALONG THE INSIDE OF THE URETHRA. THE CUSTOMER EXPERIENCED IRRITATION IN THE URETHRA AND PROBLEMS WITH URINATION. NO MEDICAL INTERVENTION WAS REPORTED. PER FOLLOW UP ON (B)(6) 2021 THE PATIENT HAD AMOUNT OF BLEEDING INCONTINENCE AND BURNING SENSATION. THE PATIENT WAS NOT USED ONE OF THE DEFECTIVE CATHETERS IN ALMOST A WEEK NOW. PER FOLLOW UP ON (B)(6) 2021 IT WAS STATED THAT THE NEW SHIPMENT HAD A NUMBER OF CATHETERS WHICH WERE CRIMPED AND ALMOST CLOSED AND WHILE INSERTING THE CATHETER SOMETIMES IT GETS DOUBLED OVER.

  Patient problems: Burn(s); Hemorrhage/Blood Loss/Bleeding; Irritability; Skin Inflammation/ Irritation; Urinary Incontinence

  MAUDE report 11897585 ↗
• MalfunctionMay 27, 2021Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE PATIENT GOT A BATCH OF TOUCHLESS PLUS CATHETERS THAT WERE NOT GOOD AND WAS UNABLE TO USE AS THE PORT HOLE WAS NOT CLOSED WITH ENOUGH LUBRICANT AND THE PIECES WAS HANGING FROM PORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11897564 ↗
• MalfunctionMay 27, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT GOT A BATCH OF CATHETERS THAT WERE NOT GOOD AND UNABLE TO USE AS THE PORT HOLE WAS CLOSED AND NOT ENOUGH LUBRICANT, ALSO THE PIECES HANGING FROM PORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11896814 ↗
• MalfunctionMay 27, 2021Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE PATIENT GOT A BATCH OF CATHETERS THAT WERE NOT GOOD AND UNABLE TO USE, AS THE PORT HOLE WAS CLOSED AND NOT HAD ENOUGH LUBRICANT, ALSO THE PIECES HANGING FROM PORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11895200 ↗
• MalfunctionMay 27, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE PATIENT GOT A BATCH OF CATHETERS THAT WERE NOT GOOD AND UNABLE TO USE, AS THE PORT HOLE WAS CLOSED AND NOT ENOUGH LUBRICANT, ALSO THE PIECES HANGING FROM PORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11895199 ↗
• MalfunctionDec 10, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE INTERMITTENT CATHETERS HAD DEFECTIVE TIPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10986233 ↗
• MalfunctionSep 16, 2020Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TOUCHLESS PLUS CATHETERS LEAKED

  Patient problems: Insufficient Information; No Consequences Or Impact To Patient

  MAUDE report 10543482 ↗
• MalfunctionSep 10, 2020Improper Chemical Reaction; Inadequate Lubrication; Improper Chemical Reaction

  IT WAS REPORTED THAT THE CATHETERS WERE NOT PROPERLY LUBRICATED AND RESULTED IN BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Patient Problem/Medical Problem

  MAUDE report 10518932 ↗
• MalfunctionSep 10, 2020Product Quality Problem; Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE CATHETERS WERE NOT PROPERLY LUBRICATED AND RESULTED IN BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Patient Problem/Medical Problem

  MAUDE report 10518926 ↗
• MalfunctionSep 10, 2020Improper Chemical Reaction; Inadequate Lubrication; Improper Chemical Reaction

  IT WAS REPORTED THAT THE CATHETERS WERE NOT PROPERLY LUBRICATED AND RESULTED IN BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Patient Problem/Medical Problem

  MAUDE report 10518896 ↗
• MalfunctionSep 10, 2020Improper Chemical Reaction; Inadequate Lubrication; Improper Chemical Reaction

  IT WAS REPORTED THAT THE CATHETERS WERE NOT PROPERLY LUBRICATED AND RESULTED IN BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Patient Problem/Medical Problem

  MAUDE report 10518879 ↗
• MalfunctionMay 22, 2020Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT HAD A SLIGHT DISCOMFORT WHEN INSERTING THE CATHETER. PER FOLLOW UP WITH CUSTOMER, THE CUSTOMER STATED THAT THERE WAS ENOUGH LUBRICATION AND THE CATHETER WAS BENT AT THE END. NO MEDICAL INTERVENTION REPORTED. THE CUSTOMER ALSO STATED THEY LIKE HOLLISTER CATHETERS BETTER THAN THESE CATHETERS.

  Patient problems: Discomfort

  MAUDE report 10082752 ↗
• MalfunctionNov 27, 2019Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem; Component Missing

  IT WAS REPORTED THAT THE PATIENT SAID ONE OF THE KITS WAS OPEN, AND DIDN¿T HAVE LITERATURE.

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

  MAUDE report 9386436 ↗