Bardex® Lubricath® Foley Catheter 0166L20Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00801741017605), received between Jul 13, 2017 and Feb 12, 2026 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2026Expiration Date Error

  IT WAS REPORTED THAT THE EXPIRATION DATE ON THE FOLEY TRAY BOX DIFFERS FROM THE EXPIRATION DATE ON THE FOLEY CATHETER. A PRODUCT WITH LOT MYKT4628 HAD A USE-BY DATE OF 2030/03/00 ON THE BOX, THE QR CODE ON THE PRODUCT INSIDE HAS AN EXPIRATION DATE OF 2030/03/28.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24323851 ↗
• InjuryDec 2, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THIS IS A CLINIC ONLY CATHETER THAT CAUSED 3 DIFFERENT PATIENTS AT THE NININGER CLINIC TO REQUIRE TRIPS TO THE ED DUE TO THE CATHETER NOT DRAINING, IT IS ONLY LOCATED AT NININGER AND HASTINGS CLINICS, THOSE CLINICS HAVE PULLED THE LOTS, AND TREENA IS WORKING WITH JULIE TO ENSURE NO OTHER IMPACTED PRODUCTS. LOT # NGJZ0361. PATIENT WAS BROUGHT TO EXAM ROOM AND PLACED IN SUPINE POSITION ON THE EXAM TABLE. CATHETER WAS IRRIGATED AND MINIMAL AMOUNT OF URINE SOLUTION WAS ABLE TO BE PULLED BACK, AND CATHETER WAS VERY SLOWLY DRAINING. BALLOON WAS DEFLATED AND URINE FLOW IMMEDIATELY INCREASED. CATHETER WAS ADVANCED 1.5 INCHES FURTHER INTO BLADDER AND WRITER BEGAN TO INFLATE BALLOON. IMMEDIATELY WHEN ANY FLUID WAS INSTILLED INTO BALLOON, URINE FLOW STOPS. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 07NOV2025, THERE WAS IMPACT TO THE PATIENT DUE TO THE THIS OF THE DEVICE. SOME CASES RESULTED IN MULTIPLE CATHETER CHANGES AND ER TRIPS WITH ALTERNATIVE CATHETER TYPES. TROUBLE SHOOTING WAS PERFORMED IN CLINIC AND ER DEPENDING ON WHERE PATIENT WAS SEEN FOR ISSUES. THE KNOWN PATIENTS AFFECTED BY THIS: PATIENT# 1 - (B)(6) (40YO WHITE MALE, HT: 5¿4¿ WT: 67KG & CATHETER CHANG

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fatigue; Urinary Frequency / Polyuria

  MAUDE report 23693136 ↗
• MalfunctionJun 24, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUSTOMER STATED THAT THEY TRIED TO USE FOLEY CATHETER BUT THE FLOW TO THE BALLOON DOESN¿T WORK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22324979 ↗
• MalfunctionMay 27, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT WHEN THE FOLEY CATHETER WAS OPENED FROM THE TRAY, THERE WAS A BLACK FOREIGN OBJECT ATTACHED TO IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22088200 ↗
• MalfunctionApr 23, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT FOLEY CATHETER BULB WOULD NOT DEFLATE ONCE INFLATED WITH STERILE WATER. MULTIPLE CATHETERS FROM THIS BOX WERE LIKE THIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21892331 ↗
• MalfunctionNov 2, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15714494 ↗
• MalfunctionMar 18, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE SIZE OF THE BALLOON IN THE FOLEY CATHETER WAS TOO BIG AND THE BALLOON COULD NOT BE INFLATED TO PROPER 30CC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13803957 ↗
• MalfunctionSep 16, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN THE PATIENT PUTS THEIR HANDS DOWN ON THE TUBE OF THE FOLEY CATHETER TO PUSH AT THE OPENING TO PUT THE CAP BACK ON, PATIENT'S HANDS WERE WET. PATIENT HAD CONTINUED TO EXPERIENCE SIMILAR ISSUES WITH IT BEING WET. PATIENT HAS BEEN USING THE PRODUCT MORE THAN 90 DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12481737 ↗
• MalfunctionApr 24, 2020Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY CATHETER THAT THE PATIENT RECEIVED HAD A HOLE IN THE BALLOON AND, THEREFORE, WAS HAVING LEAKAGE.

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

  MAUDE report 9998139 ↗
• MalfunctionMar 27, 2020Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT TWO OF THE FOLEYS HAD HOLES IN THE BALLOONS, WHICH CAUSED THEM TO LEAK.

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

  MAUDE report 9892374 ↗
• MalfunctionMar 23, 2020Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT WOKE UP DUE TO CATHETER LEAKAGE.

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

  MAUDE report 9866143 ↗
• MalfunctionMar 19, 2020Inflation Problem; Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PATIENT SAID THE BALLOON ON THE FOLEY DID NOT INFLATE CORRECTLY. SHE SAID THE NURSE TESTED THE BALLOON AND IT ONLY INFLATED ON ONE SIDE. SHE SAID IT CURLED UP INTO A ¿U¿, RISKED INJURY THE BLADDER, AND COULD NOT BE USED.

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

  MAUDE report 9853626 ↗
• MalfunctionFeb 28, 2020Fluid/Blood Leak; Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE CATHETER LEAKED.

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

  MAUDE report 9770162 ↗
• MalfunctionJan 14, 2020Inflation Problem; Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE BALLOON ON THE FOLEY CATHETER WOULD NOT INFLATE.

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

  MAUDE report 9587606 ↗
• MalfunctionNov 30, 2018Incorrect Measurement; Fluid/Blood Leak; Incorrect Measurement; Material Integrity Problem

  IT WAS REPORTED THAT THE DIAMETER OF THE CATHETER WAS THINNER THAN USUAL; AS A RESULT, THE CATHETER LEAKED. THE PATIENT WAS ABLE TO INSERT AND USE THE CATHETER. THE DEVICE WAS REPLACED.

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

  MAUDE report 8120193 ↗
• MalfunctionJul 13, 2017Inflation Problem

  IT WAS REPORTED THAT THE CATHETER BALLOON WOULD NOT INFLATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6711080 ↗