Bardex® Lubricath® Foley Catheter A304916Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741104367), received between Feb 15, 2019 and Dec 27, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jun 25, 2026Class IIOpen, Classified

   Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.

   Z-3114-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 27, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT THE LEURLOCK ON THE BALLOON PORT FELL OFF WHEN SYRINGE ATTACHED. THIS HAPPENED TWICE BEFORE FOLEY CATHETER WAS INSERTED INTO THE PATIENT. PRODUCT WAS NOT USED ON PATIENT. (DOE#(B)(6) 2024 AND DOE#(B)(6) 2024).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21026173 ↗
• MalfunctionMar 4, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT UPON FOLLOWING PROPER STERILE TECHNIQUE, REGISTERED NURSE NOTE THAT 10CC SYRINGE OF STERILE WATER DID NOT HAVE A CAP AND ONLY 3CC OF STERILE WATER. PACKAGING WAS INTACT INITIALLY COMPLETELY WITHOUT BEING COMPROMISED. THIS PACKAGING DISPOSED OF WITH NEW INDWELLING CATHETER INSERTED WITHOUT INCIDENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18825161 ↗
• MalfunctionDec 7, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE STERILE WATER SYRINGE HAD A MISSING CAP SO THE SALINE RAN INTO THE PRODUCT ON THREE TRAYS. PER FOLLOW UP INFORMATION RECEIVED ON 15DEC2023, THEY PROVIDED INSERT OF ONE FOLEY KIT TO CENTRAL SUPPLY, FOLEY KIT WAS NOT ABLE TO BE USED, ANOTHER KIT HAD TO BE OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18283251 ↗
• MalfunctionAug 10, 2023Short Fill; Short Fill

  IT WAS REPORTED THAT 3CCS OF WATER DISTRIBUTED INSTEAD OF 10CCS FROM FOLEY CATHETER. PER FOLLOW UP VIA EMAIL ON 27JUL2023, CUSTOMER JUST WANTED TO LET YOU KNOW OUR FINDINGS WHEN THEY OPENED THE STERILE COUDE CATHETER KIT. CUSTOMER WAS TOLD FROM YOUR COMPANY THAT PERHAPS THE MANUFACTURER PLACED A PEDIATRIC SYRINGE OF 3ML STERILE WATER INSIDE THE ADULT KIT. CUSTOMER ASKED DO YOU FILL YOUR PEDIATRIC NS SYRINGES WITH JUST 3ML. THEY ALSO ASKED IS IT EVEN POSSIBLE THAT THE WATER COULD EVAPORATE WITHIN A CLOSED, STERILE SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17497745 ↗
• MalfunctionFeb 15, 2019Component Missing

  IT WAS REPORTED THAT THE SURESTEP FOLEY KIT DID NOT CONTAIN A POVIDINE-IODINE FLUID POUCH OR THE REPLACEMENT SET OF IODINE PRE-SATURATED SWABSTICKS. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 8342793 ↗