Bardia® All-Silicone Foley Catheter 806524Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741039218), received between Apr 12, 2019 and Mar 2, 2021 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Biocompatibility” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 2, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION WHILE USING THE SILICONE FOLEY CATHETER AND THE PATIENT NEEDED THE ORDER TO SHIP RIGHT AWAY. IT WAS UNKNOWN IF THE DEVICE CONTRIBUTED TO THE INFECTION AT THIS TIME AND MEDICAL INTERVENTION WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 11400412 ↗
• MalfunctionNov 19, 2019Partial Blockage; Partial Blockage; Complete Blockage

  IT WAS REPORTED THAT THE CATHETER WAS CLOGGED IN THE PART THAT WAS INSIDE THE BODY.

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

  MAUDE report 9343919 ↗
• MalfunctionJul 8, 2019Break; Material Split, Cut or Torn

  IT WAS REPORTED THAT THREE CATHETERS CAME APART; THE DRAINAGE FUNNEL SPLIT AFTER ONE WEEK OF USE. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 8768039 ↗
• MalfunctionApr 12, 2019Leak/Splash

  IT WAS REPORTED THAT THE FOLEY CATHETER LEAKED.

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

  MAUDE report 8509545 ↗
• MalfunctionApr 12, 2019Burst Container or Vessel

  IT WAS REPORTED THAT THE BALLOON ON THE FOLEY CATHETER BURST.

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

  MAUDE report 8509368 ↗