Bard® Urethral Catheter 120618Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741029981), received between Jun 6, 2019 and Jul 10, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Improper Chemical Reaction” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT RUBBER OF THE INTERMITTENT CATHETER WAS A DIFFERENT COLOR AND THE PATIENT WAS HAVING TO USE TWO PACKS OF LUBRICANT PER CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22470663 ↗
• MalfunctionJul 7, 2022Improper Chemical Reaction; Naturally Worn; Improper Chemical Reaction; Naturally Worn

  IT WAS REPORTED THAT THREE OF THE INTERMITTENT CATHETER WERE FOUND DRY ROTTED INSIDE OF A SEALED STERILE PACKAGE. THERE WERE 3 CATHETERS WITH SAME ISSUE- LOT# NGCP4279. PER SAMPLE RECEIVED ON 20JUN2022, IT WAS NOTED THAT THE CUSTOMER RETURNED THE TWO INTERMITTENT CATHETER WITH THE LOT# NGDP4073 FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14944244 ↗
• MalfunctionJul 5, 2022Material Twisted/Bent; No Apparent Adverse Event; Material Twisted/Bent; No Apparent Adverse Event

  IT WAS REPORTED THAT THE TIP OF THE COUDE TIEMANN CATHETER WAS CURVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14915869 ↗
• MalfunctionJun 13, 2022Improper Chemical Reaction; Naturally Worn; Improper Chemical Reaction; Naturally Worn

  IT WAS REPORTED THAT THREE OF THE INTERMITTENT CATHETER WERE FOUND DRY ROTTED INSIDE OF A SEALED STERILE PACKAGE. THERE WERE 3 CATHETERS WITH SAME ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14674766 ↗
• MalfunctionApr 1, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE PATIENT RECEIVED A EYE TIEMANN CATHETER WITHOUT EYELETS ON THE LAST ORDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11603106 ↗
• MalfunctionMar 20, 2020Difficult to Insert

  IT WAS REPORTED THAT THE PATIENT STATED HE HAD SEVERAL EPISODES OF NOT BEING ABLE TO INSERT THE CATHETERS. IT WAS UNKNOWN IF THE PATIENT WAS ABLE TO VOID.

  Patient problems: No Consequences Or Impact To Patient; Urinary Retention

  MAUDE report 9862380 ↗
• MalfunctionJun 6, 2019Device Damaged Prior to Use; Device Damaged Prior to Use; Device Contamination with Chemical or Other Material; Material Deformation

  IT WAS REPORTED THAT THE CATHETER WAS DEFORMED. THE CUSTOMER NOTED THAT IT SEEMED LIKE THERE WAS SOMETHING STICKING OUT OF THE CATHETER.

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

  MAUDE report 8674325 ↗