Bardex® Lubricath® Foley Catheter 0166L28Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741017643), received between Jul 28, 2020 and Mar 13, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 13, 2024Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT WHILE IRRIGATING THE PEDIATRIC PATIENT¿S 2-WAY FOLEY CATHETER TUBING THE CUSTOMER WAS MEETING LOT OF RESISTANCE AND THE PATIENT WAS CRYING. IT WAS ALSO APPEARED THAT THE TUBE HAD COME OUT SLIGHTLY DUE TO THE PATIENT PUSHING IT OUT. THEN THEY RE INSERTED AND RE TAPED THE TUBE BEFORE CONTINUING. THEY CONTACTED THE CLINICAL INSTRUCTOR FOR THE DAY AND WAS TOLD THERE WERE 2 PORTS ON THE TUBE. ONE WAS TO INFLATE THE BALLOON, AND THE OTHER WAS FOR THE IRRIGATION. THEN THEY WAS TOLD THAT THEY WERE ATTEMPTING TO IRRIGATE THROUGH WAS THE BALLOON PORT, SO BY MISTAKE THEY TRIED TO INTERROGATE THAT TUBE AND THUS INFLATED THE BALLOON INSTEAD. IT WAS NOTED THAT ABDOMINAL X-RAY WAS PERFORMED AND THE PATIENT HAD SOME MILD BLEEDING AND REQUIRED NO INTERVENTION AS CONFIRMED BY X-RAY AND SURGEON EXAM. THE PATIENT WAS COMFORTABLE AND DISCHARGED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18893259 ↗
• MalfunctionSep 29, 2022Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT FOLEY CATHETER LENGTH WAS SHORTER AND WIDTH WAS SMALLER. PER FOLLOW UP VIA PHONE ON (B)(6) 2022, IT WAS REPORTED THAT THE CUSTOMER HAD ORDERED MULTIPLE FOLEYS FROM EDGE PARK THAT WERE LABELED AS SIZE 28FR WITH 30CC BALLOON (ONCE A MONTH PRESCRIPTION), BUT THEY WERE NOT THE CORRECT SIZE. PURPORTEDLY THAT THE CATHETERS WERE LARGER THAN THE ONE CUSTOMER CURRENTLY HAD IN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15508711 ↗
• MalfunctionFeb 10, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE FOLEY CATHETER INSERTED INSIDE THE PATIENT WAS LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11307771 ↗
• MalfunctionJul 28, 2020Fluid/Blood Leak; Leak/Splash; Inadequacy of Device Shape and/or Size; Fluid/Blood Leak

  IT WAS REPORTED THAT THE FOLEY CATHETERS WERE LEAKING. IT WAS ALSO STATED THAT THE CATHETERS WERE NOT BIG ENOUGH AND WANTED A 30FR.

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

  MAUDE report 10333717 ↗