Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 0170SI18Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741025358), received between Jun 5, 2019 and Feb 21, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Decrease in Pressure” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 21, 2024Calcified; Calcified

  IT WAS REPORTED THAT THE FOLEY CATHETER AND BAG WERE NOT STAYING TOGETHER, ALSO THERE WERE CRYSTALS FORMING ON THE OUTSIDE OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18747045 ↗
• MalfunctionSep 1, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE CUSTOMER HAD BEEN NOTICING THAT LOTS OF PATIENTS SEEMED TO HAVE A PROBLEM WITH THE FOLEY CATHETER BALLOON. EVERY TIME THEY VISITED, THE BALLOON HAD LOST A CONSIDERABLE AMOUNT OF WATER. SOMETIMES, BY THE END OF THE 12 WEEKS, THERE WERE ONLY 2 ML LEFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17672710 ↗
• MalfunctionAug 17, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE SILICONE FOLEY CATHETER HAD PROBLEM KEPT BREAKING OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15240321 ↗
• MalfunctionOct 28, 2021Burst Container or Vessel; Decrease in Pressure; Burst Container or Vessel; Decrease in Pressure

  IT WAS REPORTED THAT THE FOLEY CATHETERS FELL OUT SPONTANEOUSLY. IT WAS NOTED THAT THE CATHETER WAS PLACED UNDER TWO HOURS FOR EACH WHEN THE EVENT OCCURRED AND CONFIRMED THE BALLOON WAS INFLATED WITH STERILE WATER. THIS WAS FOUND TO HAPPEN IN TWO FOLEY CATHETERS, AND CUSTOMER PROVIDED LOTS FOR EACH CATHETER (LOT NO: NGFV1319 AND NGFQ3422).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12712327 ↗
• MalfunctionOct 28, 2021Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE FOLEY CATHETERS FELL OUT SPONTANEOUSLY. IT WAS NOTED THAT THE CATHETER WAS PLACED UNDER TWO HOURS FOR EACH WHEN THE EVENT OCCURRED AND CONFIRMED THE BALLOON WAS INFLATED WITH STERILE WATER. THIS WAS FOUND TO HAPPEN IN TWO FOLEY CATHETERS, AND CUSTOMER PROVIDED LOTS FOR EACH CATHETER (LOT NO: NGFV1319 AND NGFQ3422).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12712326 ↗
• MalfunctionApr 30, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE CATHETER BALLOON WAS RUPTURED. IT WAS STATED THAT THERE WAS NO PATIENT HARM. PER ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER VIA EMAIL ON (B)(6) 2021, CUSTOMER STATED THAT THERE WERE NO PIECES OBSERVED TO BE MISSING FROM THE BALLOON. AND THE CATHETERS WERE IN PLACE ABOUT 2 HOURS AND 10 ML STERILE WATER WAS USED TO INFLATE THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11755569 ↗
• MalfunctionMar 17, 2021Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE CATHETER FELL OUT AND THE PATIENT RETURNED TO THE OFFICE FOLLOWING THE CALL AND NOTED THAT THE CATHETER WAS ORIGINALLY PLACED WAS NOT INFLATED WITH WATER AT THE TIME OF REMOVAL. THE PATIENT HAD A NEW CATHETER PLACED DURING THE SECOND VISIT. 10 ML OF STERILE WATER WAS PLACED IN THE PORT OF THE CATHETER WHICH WOULD RESULT IN THE BALLOON BEING FILLED IN THE BLADDER AND FILLED THE BALLOON EXTERNAL FROM THE PATIENT AND THE WATER DID NOT LEAK OUT OF THE BALLOON EVEN HOURS AFTER THE PATIENT LEFT. THERE WAS NO OBVIOUS REASON AS WHY THE CATHETER FELL OUT OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11509455 ↗
• MalfunctionJun 5, 2019Leak/Splash; Fluid/Blood Leak; Leak/Splash

  IT WAS REPORTED THAT THE FOLEY CATHETER LEAKED.

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

  MAUDE report 8669975 ↗
• MalfunctionJun 5, 2019Break; Break; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE FOLEY CATHETER TORE AND RIPPED AT THE TIP.

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

  MAUDE report 8669973 ↗