Bardia® All-Silicone Foley Catheter 806318Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741039126), received between Oct 3, 2017 and May 12, 2023 — classified as 5 malfunctions.

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

• MalfunctionMay 12, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CUSTOMER STARTED GETTING THE 806318 FOLEY CATHETERS A COUPLE OF MONTHS AGO AND NOW THE URINE ALWAYS LEAKED AROUND THE CATHETER AND SOILED THE PATIENTS WHEELCHAIR AND BED. THEY WANTED TO GO BACK TO THE CATHETER THEY HAD BEFORE, BUT THE NUMBER THEY PROVIDED DID NOT MATCH ANYTHING BD HAD. THEY DESCRIBED THE CATHETER AS LOOKING LIKE IT WAS THE COLOR OF A TAN RUBBER BAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16918991 ↗
• MalfunctionMar 31, 2022Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE USER EXPERIENCED SYMPTOMATIC URINARY TRACT INFECTION AND CATHETER BLOCKAGE WHEN ASKED OF COMPLICATIONS WHILE USING THE FOLEY CATHETER. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13959414 ↗
• MalfunctionMay 1, 2020Burst Container or Vessel

  IT WAS REPORTED THAT THE CATHETER WOULD "BURST OPEN" ON THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10018035 ↗
• MalfunctionDec 19, 2019Material Invagination; Material Invagination; Material Deformation

  IT WAS REPORTED THAT THERE WAS A PROMINENT RIDGE IN THE BALLOON OF THE FOLEY CATHETER.

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

  MAUDE report 9497233 ↗
• MalfunctionOct 3, 2017Burst Container or Vessel

  IT WAS REPORTED THAT THE BALLOON BURST WHEN THE PATIENT BENT OVER. THE COMPLAINANT ALLEGED THAT NO PIECES WERE MISSING AND ONLY 20CC WAS USED TO FILL THE BALLOON.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6911343 ↗