Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 73022SIRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741025518), received between Nov 11, 2022 and Mar 11, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Invagination” (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.

• MalfunctionMar 11, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT TRANSURETHRAL RESECTION OF THE PROSTATE PROCEDURE WAS DONE AT THE END PLACED A BARD 22 FR 30CC/ML BALLOON LATEX FREE FOLEY CATHETER. AFTER THE CATHETER WAS ATTACHED TO CONTINUOUS BLADDER IRRIGATION, THE SURGEON NOTICED SALINE LEAKING FROM THE CATHETER NEAR THE TRIPLE LUMEN SITE. FOLEY CATHETER WAS NOTED TO HAVE A PUNCTURE IN IT CAUSING FLUID TO LEAK OUT. PHYSICIAN HAD TO QUICKLY REPLACE FOLEY CATHETER WITH A NEW ONE. CATHETER AND PACKAGING WERE PLACED IN BAG FOR RISK MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21574459 ↗
• MalfunctionNov 11, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE NURSE HAD DEFLATED THE BALLOON AND ATTEMPTED TO REMOVE FOLEY CATHETER SEVERAL TIMES WITHOUT SUCCESS. ABOUT AN INCH OF THE FOLEY WAS STUCK IN THE PENIS. IT WAS STATED THAT THE NURSE HAD CALLED FOR HELP AND GOT A SECOND OPINION BEFORE CALLING THE DOCTOR. IT WAS A NON-LATEX 22 FR FOLEY CATHETER THAT SOMETIMES HAD A RIDGE NEAR THE BALLOON. AFTER THE NURSE CAME TO THE PATIENT TO PULL IT, THEY FOUND THE BALLOON HAD DEFLATED AND THE PLASTIC HAD FOLDED OVER ON ITSELF INSTEAD OF LYING FLAT. STATED THAT CAUSED PAIN FOR THE PATIENT WHO HAD TO SIT WITH IT AT THE TIP OF THE PENIS FOR APPROXIMATELY 40 MINUTES WHILE STAFF TROUBLESHOOT THE PROBLEM. DOCTOR HAD TO TUG ON THE CATHETER FIRMLY UNTIL IT POPPED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15780797 ↗
• MalfunctionNov 11, 2022Material Invagination; Material Invagination

  IT WAS REPORTED THAT THE NURSE HAD DEFLATED THE BALLOON AND ATTEMPTED TO REMOVE FOLEY CATHETER SEVERAL TIMES WITHOUT SUCCESS. ABOUT AN INCH OF THE FOLEY WAS STUCK IN THE PENIS. IT WAS STATED THAT THE NURSE HAD CALLED FOR HELP AND GOT A SECOND OPINION BEFORE CALLING THE DOCTOR. IT WAS A NON-LATEX 22 FR FOLEY CATHETER THAT SOMETIMES HAD A RIDGE NEAR THE BALLOON. AFTER THE NURSE CAME TO THE PATIENT TO PULL IT, THEY FOUND THE BALLOON HAD DEFLATED AND THE PLASTIC HAD FOLDED OVER ON ITSELF INSTEAD OF LYING FLAT. ALSO STATED THAT CAUSED PAIN FOR THE PATIENT WHO HAD TO SIT WITH IT AT THE TIP OF THE PENIS FOR APPROXIMATELY 40 MINUTES WHILE STAFF TROUBLESHOOT THE PROBLEM. DOCTOR HAD TO TUG ON THE CATHETER FIRMLY UNTIL IT POPPED OUT.

  Patient problems: Pain

  MAUDE report 15779333 ↗