Bard® Touchless® Plus Unisex Pre-Lubricated Red Rubber Urethral Catheter 4A6044Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741030529), received between Aug 16, 2018 and Feb 11, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Product Quality Problem” (4 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.

• MalfunctionFeb 11, 2026Nonstandard Device

  IT WAS REPORTED BY THE CUSTOMER CONTACTED 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 24314958 ↗
• MalfunctionJan 14, 2022Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT ALL 6 OF THE TOUCHLESS PLUS RED RUBBER CATHETERS WERE STOPPED UP AND IT WAS UNABLE TO GET ANY URINE OUT. ALSO NOTED THAT PATIENTS HAD BEEN USING THE CATHETERS FOR MORE THAN 90 DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13258244 ↗
• MalfunctionJan 23, 2020Product Quality Problem; Defective Device; Product Quality Problem

  IT WAS REPORTED THAT THE LUBRICANT ON THE CATHETER WAS NOT ENOUGH. THE PATIENT STATED THAT HE HAD TO ADD HIS OWN LUBRICANT DURING USAGE. NO MEDICAL INTERVENTION REQUIRED.

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

  MAUDE report 9621471 ↗
• MalfunctionDec 16, 2019Product Quality Problem; Product Quality Problem; Defective Device

  IT WAS REPORTED THAT THERE WAS NOT ENOUGH LUBRICANT ON THE TOUCHLESS PLUS.

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

  MAUDE report 9474794 ↗
• MalfunctionJun 10, 2019Product Quality Problem; Difficult to Insert; Product Quality Problem

  IT WAS REPORTED THAT THE CATHETER HAD A LACK OF LUBRICITY.

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

  MAUDE report 8684068 ↗
• MalfunctionAug 16, 2018Product Quality Problem; Appropriate Device Problem Term/Code Not Available; Product Quality Problem

  IT WAS REPORTED THAT THE CATHETER HAD A LACK OF LUBRICITY.

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

  MAUDE report 7788368 ↗