Bardex® Lubricath® Foley Catheter 0125RL22Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741019166), received between Apr 24, 2018 and Sep 24, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2020Decrease in Pressure; Gas/Air Leak; Device Fell; Decrease in Pressure

  IT WAS REPORTED, THAT THE 3 WAY IRRIGATION FOLEY CATHETER BALLOON HAD DEFLATION ISSUE. PER FOLLOW UP VIA EMAIL ON (B)(6) 2020, THE CATHETER DEFLATED AND CAME OUT, WHILE THE PATIENT WAS IN PACU (POST ANESTHETIC CARE UNIT) POST SURGICAL INSERTION. CATHETER BALLOON RECHECKED, AFTER FOUND OUT OF PATIENT(SELF DEFLATED). RECHECKED AFTER- SLOWLY DEFLATES WHEN AIR INSERTED-NO VISIBLE HOLE (APPEARS PATENT). THE PATIENT HAD TO RETURN (2ND TAKE BACK) TO SURGERY. PER THE UROLOGIST, FOR BLOOD CLOT EVACUATION/EVALUATION AND REINSERTION OF CATHETER. BALLOON WAS INFLATED WITH STERILE NORMAL SALINE PER OR NURSE. PER SURGEON, THE BALLOON WAS INFLATED WITH 45ML.

  Patient problems: Insufficient Information; Patient Problem/Medical Problem

  MAUDE report 10582618 ↗
• MalfunctionMay 27, 2020Component Missing

  IT WAS REPORTED THAT THE 3 WAY CATHETER COULD NOT BE IRRIGATED. ONCE REMOVED FROM THE PATIENT, THE USER FOUND THAT THE CATHETER WAS MISSING THE IRRIGATION EYE HOLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10093036 ↗
• MalfunctionMay 27, 2020Component Misassembled; Inability to Irrigate; Component Misassembled

  IT WAS REPORTED THAT THE 3 WAY CATHETER COULD NOT BE IRRIGATED. ONCE REMOVED FROM THE PATIENT, THE USER FOUND THAT THE CATHETER WAS MISSING THE IRRIGATION EYE HOLE. PER INVESTIGATION RESULTS, IT WAS FOUND THAT A MISSING IRRIGATION EYE PREVENT IRRIGATION AND BOTH THE EVENTS ARE CASCADING.

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

  MAUDE report 10092840 ↗
• MalfunctionApr 24, 2018Device Damaged Prior to Use; Fluid/Blood Leak; Device Damaged Prior to Use; Dent in Material

  IT WAS REPORTED THAT THE INLET PORT OF THE 3-WAY IRRIGATION CATHETER HAD TWO INDENTATIONS CAUSING WATER TO ESCAPE FROM THE BLADDER IRRIGATION INLET PORT.

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

  MAUDE report 7453657 ↗