Bardia® All-Silicone Foley Catheter 806324Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741039157), received between Nov 26, 2019 and Jun 25, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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.

• MalfunctionJun 25, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT SUPRAPUBIC FOLEY CATHETER LEAKED URINE THROUGH THE CATHETER HOLE IN THE PATIENT'S ABDOMEN. THE USER WAS LOOKING TO GET A GASKET RING OR A TYPE OF PLUG THAT WOULD HELP STOP THIS LEAKING. IT OBVIOUSLY MUST BE MEDICAL GRADE MATERIAL, AS PART OF THIS PLUG WOULD BE INSIDE THE PATIENT'S ABDOMEN WALL. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 11JUN2021, THE CUSTOMER STATED THAT THE CATHETERS THAT THE PATIENT WAS USING WERE NO WAY DEFECTIVE OR PERFORMING ANY LESS THAN EXPECTED. IT WAS STATED THAT THE MEDICATED CATHETER HAD DRAMATICALLY LESSENED THE NUMBER OF BLADDER INFECTIONS. THE CUSTOMER WANTED TO KNOW IF BD HAD ANY MEDICAL-GRADE TYPE OF PLUG. THE BACK OF THE PLUG MIGHT EVEN HAVE WATERPROOF, SKIN-RATED ADHESIVE WHICH WOULD KEEP IT AGAINST THE PATIENT'S SKIN, SO LEAKING URINE WOULD NOT LOOSEN IT FROM THE SKIN. FOLLOW UP VIA PHONE ON 11JUN2021, IT WAS STATED THAT THE PATIENT WAS GETTING THE INFECTIONS BEFORE THE PATIENT WAS USING THE CATHETERS. THE CUSTOMER WAS VERY PLEASED WITH THE CATHETERS AND DID NOT FEEL THE INFECTIONS WERE CAUSED BY THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12071612 ↗
• MalfunctionMar 19, 2020Failure to Infuse

  IT WAS REPORTED THAT THE FOLEYS WOULD NOT INFUSE.

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

  MAUDE report 9856616 ↗
• MalfunctionNov 26, 2019Material Invagination; Material Invagination; Difficult to Remove

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS DIFFICULT TO REMOVE DUE TO A RIDGE AT THE TOP OF THE CATHETER. THE CATHETER WAS REPORTEDLY REMOVED AND REPLACED AT THE DOCTOR'S OFFICE.

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

  MAUDE report 9379427 ↗