Bardex® Lubricath® Foley Catheter 0119L16Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00801741019050), received between Feb 22, 2023 and Jun 25, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (7 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2026Material Puncture/Hole

  IT WAS REPORTED THAT FEW HOURS, SEVERAL HOURS AFTER PLACEMENT OF THE FOLEY CATHETER SPONTANEOUS WATER LEAKAGE DUE TO THIS CATHETER FELL OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25620798 ↗
• MalfunctionMar 16, 2026Material Puncture/Hole

  IT WAS REPORTED THAT FIXED WATER LEAKED FROM THE FOLEY CATHETER DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24612398 ↗
• MalfunctionJan 7, 2026Deflation Problem

  IT WAS REPORTED THAT WHEN ATTEMPTED TO OPEN AND SET THE FOLEY TRAY, IT WAS CONFIRMED THAT THE FOLEY CATHETER WAS CUT IN THE MIDDLE AS IF SLICED WITH SOMETHING SHARP, SO ITS USE WAS DISCONTINUED. THEY WANT TO KNOW THE POSSIBLE CAUSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23999155 ↗
• MalfunctionOct 15, 2025Material Puncture/Hole; Material Rupture; Material Puncture/Hole; Material Rupture

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON WAS SPONTANEOUSLY REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23290097 ↗
• MalfunctionOct 6, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY CATHETER SPONTANEOUSLY FELL OUT OF THE PATIENT AFTER THREE DAYS OF PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23221645 ↗
• MalfunctionSep 23, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT IT SEEMS THAT THE FOLEY CATHETER WATER COULD NOT BE DRAINED EVEN THOUGH A SYRINGE WAS INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23124287 ↗
• MalfunctionSep 4, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT 2 DAYS AFTER PLACEMENT THE FOLEY CATHETER HAD NATURAL REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22965960 ↗
• MalfunctionAug 7, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT STERILIZATION NEST LEAKS FROM AROUND THE FOLEY CATHETER VALVE. DISCARD THE ACTUAL PRODUCT. COLLECT ONLY THE LEAFLET. STERILE WATER LEAKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22737076 ↗
• MalfunctionJun 17, 2025Material Puncture/Hole; Device Dislodged or Dislocated; Material Puncture/Hole; Device Dislodged or Dislocated

  IT WAS REPORTED THAT FOLEY CATHETER WAS INSERTED ON 29MAY, AND IT WAS CONFIRMED THAT THE CATHETER HAD BEEN REMOVED IN THE WARD ON THE SAME DAY. STERILE WATER WAS ADDED, AND THE BALLOON WAS INFLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22234767 ↗
• MalfunctionApr 28, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON WAS NATURALLY REMOVED. IT WAS PLACED ON APRIL 6TH AND WAS DISCOVERED TO HAVE NATURALLY REMOVED ON APRIL 7TH. WHEN THE CATHETER WAS CHECKED, THE BALLOON HAD RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21918534 ↗
• MalfunctionApr 28, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON WAS NATURALLY REMOVED. IT WAS PLACED ON APRIL 5TH AND WAS DISCOVERED TO HAVE NATURALLY REMOVED ON APRIL 6TH. WHEN THE FOLEY CATHETER WAS CHECKED, THE BALLOON HAD RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21917884 ↗
• MalfunctionMar 31, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DURING PRETEST, WATER LEAKED FROM THE FOLEY CATHETER BALLOON DURING PRETEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21729817 ↗
• MalfunctionFeb 22, 2023Illegible Information; Unclear Information; Illegible Information; Unclear Information

  IT WAS REPORTED THAT THE SURVEY RESPONDENT STATED NO, THEY DID NOT AGREE THAT THE INSTRUCTIONS FOR USE (IFU) FOR THE FOLLOWING BARD OR BECTON DICKINSON PRODUCTS PROVIDES SUFFICIENT INFORMATION ABOUT THE PRODUCTS AND THEIR MEDICAL APPLICATIONS BECAUSE OF UNCLEAR INFORMATION, MISSING INFORMATION, LACK OF MAINTENANCE DOCUMENTATION OR GUIDELINES, INADEQUATE INSTRUCTIONS FOR HEALTHCARE PROFESSIONAL AND INADEQUATE OR INSUFFICIENT TRAINING IN RELATION TO LUBRICATH®, 3-WAY, 5CC BALLOON, FRENCH SIZE 16.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16418046 ↗
• MalfunctionFeb 22, 2023Missing Information; Missing Information

  IT WAS REPORTED THAT THE SURVEY RESPONDENT STATED NO, THEY DID NOT AGREE THAT THE INSTRUCTIONS FOR USE (IFU) FOR THE FOLLOWING BARD OR BECTON DICKINSON PRODUCTS PROVIDES SUFFICIENT INFORMATION ABOUT THE PRODUCTS AND THEIR MEDICAL APPLICATIONS BECAUSE OF UNCLEAR INFORMATION, MISSING INFORMATION, LACK OF MAINTENANCE DOCUMENTATION OR GUIDELINES, INADEQUATE INSTRUCTIONS FOR HEALTHCARE PROFESSIONAL AND INADEQUATE OR INSUFFICIENT TRAINING IN RELATION TO LUBRICATH®, 3-WAY, 5CC BALLOON, FRENCH SIZE 16.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16417035 ↗
• MalfunctionFeb 22, 2023Inadequate or Insufficient Training; Inadequate or Insufficient Training

  IT WAS REPORTED THAT THE SURVEY RESPONDENT STATED NO, THEY DID NOT AGREE THAT THE INSTRUCTIONS FOR USE (IFU) FOR THE FOLLOWING BARD OR BECTON DICKINSON PRODUCTS PROVIDES SUFFICIENT INFORMATION ABOUT THE PRODUCTS AND THEIR MEDICAL APPLICATIONS BECAUSE OF UNCLEAR INFORMATION, MISSING INFORMATION, LACK OF MAINTENANCE DOCUMENTATION OR GUIDELINES, INADEQUATE INSTRUCTIONS FOR HEALTHCARE PROFESSIONAL AND INADEQUATE OR INSUFFICIENT TRAINING IN RELATION TO LUBRICATH®, 3-WAY, 5CC BALLOON, FRENCH SIZE 16.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16417026 ↗