Bardex® Lubri-Sil® All-Silicone Foley Catheter 176816Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741034213), received between Jun 8, 2018 and Sep 1, 2021 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2021Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE CATHETER HAD A HOLE IN THE BALLOON, WHEN THE DOCTOR ATTEMPTED TO INSTILL WATER IN THE BALLOON IT DID NOT INFLATE. AFTER THAT THE CATHETER WAS REMOVED FROM THE PATIENT, THE WATER WAS INSTILLED AGAIN AND IT WAS FOUND THAT THE WATER WAS COMING OUT THROUGH A HOLE IN THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12407425 ↗
• MalfunctionApr 20, 2021Material Invagination; Material Invagination

  IT WAS REPORTED THAT A SIGNIFICANT RIDGE FORMED ON THE BALLOON OF THE CATHETER AND IT WAS DIFFICULT TO REMOVE THE CATHETER WITH BEING UNPLEASANT FOR THE PATIENT. PER ADDITIONAL INFORMATION VIA EMAIL FROM IBC ON 08APR2021, THE CATHETER REMOVAL CAUSED PAIN TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 11692806 ↗
• MalfunctionMay 15, 2019Deflation Problem; Material Invagination; Material Invagination

  IT WAS REPORTED THAT THE CATHETER DEFLATED PREMATURELY AND CAUSED THE BALLOON TO MUSHROOM. AS A RESULT THE CATHETER WAS DIFFICULT TO REMOVE. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 8612574 ↗
• MalfunctionSep 13, 2018Difficult to Insert; Patient-Device Incompatibility; Difficult to Insert

  IT WAS REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED PAIN UPON INSERTION OF THE CATHETER. PER ADDITIONAL INFORMATION RECEIVED FROM THE COMPLAINANT VIA PHONE ON (B)(6) 2018, THE PATIENT REPORTED THAT THE CATHETER WAS UNABLE TO BE FULLY INSERTED. NO MEDICAL INTERVENTION REPORTED.

  Patient problems: Pain

  MAUDE report 7873831 ↗
• MalfunctionSep 13, 2018Inflation Problem; Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS DIFFICULT FOR THE PATIENT'S DOCTOR TO INFLATE.

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

  MAUDE report 7873828 ↗
• MalfunctionSep 11, 2018Deflation Problem; Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS DIFFICULT FOR THE PATIENT'S DOCTOR TO DEFLATE.

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

  MAUDE report 7864366 ↗
• MalfunctionJun 8, 2018Incorrect Measurement; Device Operates Differently Than Expected; Incorrect Measurement

  IT WAS REPORTED THAT THE CATHETER APPEARED TO BE THINNER THAN USUAL.

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

  MAUDE report 7582120 ↗