Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 1768SI16Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741025273), received between Dec 28, 2022 and Sep 18, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Deflation Problem” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2025Inflation Problem; Dent in Material; Inflation Problem; Dent in Material

  PATIENT SAID THE BALLOON WAS SIDEWAYS AND DIDN'T INFLATE. NO MEDIAL INTERVENTION OR PATIENT IMPACT REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23083915 ↗
• InjuryJan 6, 2023Material Invagination; Material Invagination

  IT WAS REPORTED THAT THIS WAS SECOND TIME THE PATIENT HAS HAD TO HAVE SURGERY TO HAVE THIS FOLEY CATHETER REMOVED. PATIENT TOLD THERE WAS A FLAW IN THE DESIGN OF THE FOLEY CATHETER BECAUSE IT WAS RIBBED AND THAT WAS CAUSING THE PATIENT UNABLE TO REMOVE IT.

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

  MAUDE report 16114751 ↗
• InjuryDec 28, 2022Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE PATIENT HAD TO GO THE HOSPITAL TO SURGICALLY REMOVE THE FOLEY CATHETER, BECAUSE IT WAS STUCK INSIDE THE PATIENT AND THE BALLOON WOULD NOT DEFLATE WITHOUT SURGICAL REMOVAL.

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

  MAUDE report 16062979 ↗