Bardia® Foley Catheter Silicone Coated 123528ARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741095153), received between Apr 3, 2020 and Aug 8, 2024 — classified as 1 injury, 4 malfunctions.

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

• InjuryAug 8, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT HAD BEEN GETTING BLADDER INFECTIONS WHILE USING THE FOLEY CATHETER. IT WAS UNKNOWN IF THE DEVICE CAUSED THE BLADDER INFECTION AND WHAT MEDICAL INTERVENTION WAS PROVIDED FOR THE BLADDER INFECTION AT THIS TIME.

  Patient problems: Unspecified Infection

  MAUDE report 19940964 ↗
• MalfunctionJan 13, 2022Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE FOLEY CATHETER BACKED UP AND HAD TO USE ANOTHER ONE. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 29DEC2021, IT WAS REPORTED THAT THE FOLEY CATHETER BACKED UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13256732 ↗
• MalfunctionJun 21, 2021Calcified; Calcified

  IT WAS REPORTED THAT THE CATHETER DID NOT LAST FOR THIRTY DAYS AND ALSO INSISTED AS BARD PUTS SOMETHING IN THE FOLEY CATHETER THAT WAS COMING OUT. THE REPRESENTATIVE EXPLAINED THAT, PATIENTS SOMETIMES MAKE SEDIMENT IN THEIR URINE THAT CAN ACCUMULATE ON THE INNER WALLS OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12035481 ↗
• MalfunctionApr 8, 2020Deflation Problem; Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE CATHETER BALLOON WAS DIFFICULT TO DEFLATE DURING PRETEST.

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

  MAUDE report 9940505 ↗
• MalfunctionApr 3, 2020Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE PACKAGE WAS BROKEN. PER ADDITIONAL INFORMATION FROM THE IBC VIA EMAIL 20MAR2020, THE PACKAGE WAS TORN ON ONE END.

  Patient problems: No Patient Involvement

  MAUDE report 9922649 ↗