Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 73016SIRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741025488), received between Jan 23, 2020 and Dec 3, 2024 — classified as 1 injury, 3 malfunctions.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2024Partial Blockage; Inadequacy of Device Shape and/or Size; Partial Blockage; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE CRITICAL CARE NURSES REPORTED IN AN ONLINE SURVEY THAT SUCCESSFUL DRAINAGE OF URINE WAS NOT ACHIEVED FROM USE OF THIS PRODUCT (3-WAY 30CC LUBRISIL IC CATHETERS, 16 FR) BECAUSE THE PATIENT HAD A BLOCKAGE OF SCAR TISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20832497 ↗
• InjuryNov 27, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED BY THE CRITICAL CARE NURSES IN AN ONLINE SURVEY THAT THE PATIENT EXPERIENCED AND ADVERSE EVENT DIRECTLY CAUSED ATTRIBUTABLE TO THE USAGE OF FOLEY CATHETER AND RESULTED IN HEMATURIA AND SEPSIS. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR THE SEPSIS AND HEMATURIA.

  Patient problems: Hematuria; Sepsis

  MAUDE report 20797796 ↗
• MalfunctionMay 27, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WAS A SPLIT IN CATHETER AT Y CONNECTION AND THE CONTINUOUS BLADDER IRRIGATION (CBI) FLUID WAS LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14526760 ↗
• MalfunctionJan 23, 2020Deflation Problem; Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE INFLATION VALVE BECAME DETACHED DURING USE. THE USER TRIED TO DEFLATE THE BALLOON BY USING A BLUNT TIP NEEDLE IN THE INFLATION LUMEN TO NO AVAIL. THE USER THEN CONTACTED MEDICAL SERVICES WHO ADVISED TO INVOLVE THE UROLOGIST AND DISCUSSED POSSIBLE WAYS FOR DEFLATION. IN THE END MINERAL OIL WAS EMPLOYED TO DEGRADE THE BALLOON AND THE CATHETER WAS REMOVED SUCCESSFULLY. NO FURTHER MEDICAL INTERVENTION REQUIRED.

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

  MAUDE report 9621724 ↗