Bardia® All-Silicone Foley Catheter 806510Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741072918), received between Mar 10, 2023 and Aug 3, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Inadequate Instructions for Healthcare Professional” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 3, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50110030 ↗
• MalfunctionMar 10, 2023Inadequate Instructions for Healthcare Professional; Wrong Label; Inadequate Instructions for Healthcare Professional; Wrong Label

  IT WAS REPORTED THAT THE CUSTOMER THAT ORDERED PART 806510 THROUGH MCKESSON. THE DESCRIPTION IN THEIR CATALOGUE STATED CATHETER, FOLEY SILICONE 5CC 10FR (12/CS) WHEN THE CUSTOMER OPENED THE BOX, THE PACKAGES INSIDE OF IT STATED, THEY WERE 3CC. THE LOT ON THE CASE OF CATHETERS WAS NGGW4222, AND THE LOT NUMBER ON THE ACTUAL CATHETER WAS NGGX3331. THE CUSTOMER WAS CONCERNED THAT THERE MIGHT HAVE BEEN AN ERROR ON BD¿S PART WHEN PACKAGING THIS ITEM, SINCE THE ITEM STATED IT WAS A 5CC, BUT THE REFERENCE NUMBER THAT MATCH WHAT THEY ORDERED AND WHAT WAS IN THE PACKAGE STATED IT WAS A 3CC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16520854 ↗