Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 1768SI20Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741025297), received between Oct 1, 2018 and Jun 25, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Inaccurate Flow Rate” (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.

• MalfunctionJun 25, 2026Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT THE LUBRICATED SILICONE INTERMITTENT CATHETER, ALL SILICONE, 20 FR ARE LEAKING, ALSO THE BALLON WAS DEFLATING AND COLLAPSING, MAKING IT DIFFICULT TO USE IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25630818 ↗
• MalfunctionJun 25, 2026Material Puncture/Hole; Material Rupture

  IT WAS REPORTED BY CUSTOMER THAT THE LUBRICATED SILICONE INTERMITTENT CATHETER, ALL SILICONE, 20 FR ARE LEAKING, ALSO THE BALLON WAS DEFLATING AND COLLAPSING, MAKING IT DIFFICULT TO USE IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25630816 ↗
• MalfunctionSep 12, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT CURRENTLY PATIENT USING FOLEY CATHETER, BUT THEY WERE HAVING ISSUES WITH IT NOT DRAINING WHILE THEY WERE SLEEPING (LYING DOWN). THEY THOUGHT MIGHT BE THEIR BLADDER HAS SHRUNK, AND THE EYELETS WERE TOUCHING THE BLADDER WALLS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23037074 ↗
• MalfunctionSep 10, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT CUSTOMER HAVING SOME ISSUES WITH FOLEY CATHETER, THIS WAS THE CURRENT CATHETER THEY WERE USING BUT HAVING ISSUES WITH IT NOT DRAINING WHILE THEY WERE SLEEPING (LYING DOWN). THEY THOUGHT MIGHT BE BLADDER HAS SHRUNK, AND THE EYELETS WERE TOUCHING THE BLADDER WALLS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23016318 ↗
• MalfunctionMar 7, 2025Difficult to Insert; Difficult to Insert

  PATIENT SAID IT WORKED WELL, BUT SHE HAD DIFFICULTY INSERTING POSSIBLY DUE TO BALLOON SIZE. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO ADDITIONAL INFORMATION PROVIDED. PATIENT EMAIL:(B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21547551 ↗
• InjuryOct 1, 2018Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED EXCESSIVE BLEEDING FOR TWO DAYS WHEN THE CATHETER WAS CHANGED. THE AMOUNT OF BLEEDING WAS UNKNOWN. HOWEVER NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Blood Loss; Patient Problem/Medical Problem

  MAUDE report 7923995 ↗