Bardex® Lubricath® Foley Catheter 0166L22Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741017612), received between Oct 2, 2018 and Aug 18, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (2 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.

• MalfunctionAug 18, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50311244 ↗
• MalfunctionMar 18, 2026Material Puncture/Hole

  IT WAS REPORTED THAT THE CATHETER FELL OUT OF THE PATIENT SHORTLY AFTER PLACEMENT, AND A HOLE IN THE BALLOON WAS IDENTIFIED, PREVENTING INFLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24630889 ↗
• MalfunctionAug 8, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE FOLEYS ARE NOT STAYING IN THE PATIENT AND THE NURSING TEAM IS QUESTIONING THE INTEGRITY OF THE PRODUCT. PER THE CUSTOMER COMPLAINT, THEY DID NOT HAVE ALL THE DETAILS BUT THE PICTURES OF FOLEYS THAT THE NURSING TEAM HAD ISSUES WITH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22749791 ↗
• MalfunctionMar 4, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE HOME NURSE HAD A PATIENT WHO HAD BEEN USING LUBRICATH FOLEY TRAY, 0166L22, FOR 4-5 YEARS. THEY PLACED A NEW FOLEY AND PATIENT WAS LEAKING AND HAVING BLADDER SPASMS AND ASKED IF THERE WAS ANY CHANGE THE LATEX USED IN THE FOLEYS. REPRESENTATIVE DISCUSSED INFLATION VOLUMES AND NURSE MENTIONED THEY WERE ONLY INFLATING BALLOON WITH 30CC, EXPLAINED OVER/UNDER INFLATION AND HOW THE BALLOON SHOULD BE INFLATED WITH 35CC, AND SUGGESTED THE PATIENT TO REACH OUT TO UROLOGIST TO SEE IF THERE WAS ANYTHING ELSE GOING ON AND WHAT THEY SHOULD DO NEXT.

  Patient problems: Cramp(s) /Muscle Spasm(s)

  MAUDE report 18825811 ↗
• MalfunctionMay 7, 2019Inflation Problem; Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT WHILE ATTEMPTING TO PLACE THE CATHETER INTO THE PATIENT'S CERVIX, UPON INFLATION OF THE BALLOON, THE CATHETER ATTACHED TO THE FLUID PORT AND WAS FILLING WITH FLUID. THE FLUID WAS NOT GOING INTO THE BALLOON. THE CATHETER WAS REMOVED AND A NEW ONE WAS PLACED. IT WAS LATER REPORTED PER ADDITIONAL INFORMATION FROM THE COMPLAINANT VIA EMAIL ON (B)(6)2019: THE FLUID WAS GOING INTO THE SHAFT OF THE CATHETER INSTEAD OF THE BALLOON OF THE CATHETER.

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

  MAUDE report 8589203 ↗
• MalfunctionOct 2, 2018Leak/Splash

  IT WAS REPORTED THAT THE BALLOON OF THE CATHETER ONLY INFLATED TO ONE SIDE, CAUSING LEAKAGE DURING USE.

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

  MAUDE report 7927786 ↗