Bard® Touchless® Plus Unisex Pre-Lubricated Vinyl Coude Urethral Catheter Kit 4A7116Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741046469), received between Jul 3, 2019 and Aug 18, 2022 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Structural Problem” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING ISSUES WITH SOME OF THE TOUCHLESS CATHETER. THE PATIENT HAD WASTED 5 OUT OF THE LAST ORDER DUE TO INSERTION AND LEAKAGE PROBLEMS, GOT AUTHORIZATION TO REPLACE THOSE 5.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15251615 ↗
• MalfunctionMay 20, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE TEN OF THE TOUCH LESS CATHETERS WAS HAVING A PINHOLE AND RESULTED IN LEAK. ALSO STATED THAT THE CATHETER TUBING WAS KINKED AT THE POINT WHERE THE CATHETER WAS INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11857961 ↗
• MalfunctionMay 20, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT TEN TOUCHLESS CATHETERS WERE HAVING A PINHOLE AND RESULTED IN LEAKAGE. IT WAS ALSO STATED THAT THE CATHETER TUBING WAS KINKED TO THE POINT WHERE INSERTION OF CATHETER WAS NOT POSSIBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11853612 ↗
• MalfunctionSep 2, 2020Difficult to Insert; Structural Problem; Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT THE NEW TOUCHLESS PLUS INTERMITTENT CATHETER SYSTEMS WERE BEING DIFFICULT TO INSERT AS THE TIP WAS TOO POINTED.

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

  MAUDE report 10482447 ↗
• InjuryMay 18, 2020Biocompatibility; Biocompatibility; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE CATHETERS DID NOT WORK WELL AND THE PATIENT EXPERIENCED A URINARY TRACT INFECTION WHEN USING THEM.

  Patient problems: Urinary Tract Infection

  MAUDE report 10065377 ↗
• MalfunctionJul 3, 2019Misassembled; Misassembled; Structural Problem

  IT WAS REPORTED THAT THE CURVE OF THE COUDE CATHETER TIP WAS "VERY SLIGHT" AND AS A RESULT THE PATIENT DID NOT KNOW IF THE TIP WAS UP OR DOWN. THE PATIENT WAS USING A MARKER TO INDICATE WHERE THE CORRECT DIRECTION FOR INSERTION. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 8757903 ↗