Bardia® All-Silicone Foley Catheter 806522Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741039201), received between Apr 23, 2018 and Oct 17, 2022 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Decrease in Pressure” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2022Failure to Infuse; Device Handling Problem; Failure to Infuse; Device Handling Problem

  IT WAS REPORTED THAT THE CUSTOMER HAD 2 FOLEY CATHETERS THAT HAD AN ISSUE AND IT HAPPENED ON THE SAME PATIENT, SO IT TOOK THEM 3 FOLEYS FOR ONE PATIENT. THE FOLEY CATHETER WAS BLOWING UP RIGHT BELOW THE LURELOCK, NOT ALLOWING THEM TO BLOW UP THE BALLOON DURING A ROUTINE FOLEY CHANGE. THE PATIENT HAD TO HAVE MULTIPLE FOLEYS INSERTED UNTIL ONE WORKED, AND IT WAS NOT A GREAT EXPERIENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15616782 ↗
• MalfunctionSep 27, 2021Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE BULB OF THE FOLEY CATHETER WAS NOT HELD IN POSITION FOR THE PAST 6 WEEKS. IT WAS STATED THAT THE BULB OF THE CATHETER STARTED TO LEAK, SO THE PATIENT NEEDS TO CHANGE THE CATHETER. NO ADDITIONAL INFORMATION WAS PROVIDED. IT WAS NOTED THAT THE PATIENT HAD BEEN USING THE PRODUCT FOR MORE THAN 90 DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12532846 ↗
• MalfunctionJun 24, 2021Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED BY THE PATIENT THAT THE BALLOONS ON THE SILICONE FOLEY CATHETERS WERE DEFLATED AND STATED IT MIGHT HAVE A PINHOLE BECAUSE THEY WERE SUPPOSED TO LAST FOR SIX WEEKS BUT TWO OF THE CATHETERS WERE LASTED OUT OF FOUR. IT WAS STATED THAT THE EVENT HAPPENED AT NIGHT SO IN ORDER TO CHANGE THE CATHETER THE PATIENT HAD TO VISIT THE EMERGENCY ROOM. PER CUSTOMER VIA PHONE ON 29JUL2021 THE CUSTOMER INDICATED THAT THERE SEEMED TO BE A PINHOLE IN THE BULB WHICH CAUSED THE BALLOON TO DEFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12059684 ↗
• MalfunctionJul 7, 2020Burst Container or Vessel; Deflation Problem; Device Slipped; Burst Container or Vessel

  IT WAS REPORTED THAT THE CATHETER BALLOON DEFLATED ON ITS OWN AND FELL OUT OF THE PATIENT AFTER A WEEK OF USE. THE PATIENT NOTED THAT A HOLE WAS PRESENT ON THE BALLOON. PER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 08JUL2020, IT WAS REPORTED THAT THE VISUAL INSPECTION NOTED THE BALLOON APPEARED BURST. FURTHER INSPECTION NOTED THE BALLOON APPEARED TO HAVE NO MISSING PIECES.

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

  MAUDE report 10240304 ↗
• MalfunctionJul 7, 2020Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE CATHETER BALLOON DEFLATED ON ITS OWN AND THE CATHETER FELL OUT OF THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10240302 ↗
• MalfunctionApr 13, 2020Deflation Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE CATHETER HAD A PINHOLE CAUSING IT TO DEFLATE PREMATURELY.

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

  MAUDE report 9954374 ↗
• MalfunctionApr 23, 2018Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE FOLEY CATHETER THAT THE PATIENT WAS USING SUPRAPUBICALLY FELL OUT OF THE PATIENT AFTER 2 WEEKS OF USE. UPON INSPECTION OF THE CATHETER, THE PATIENT ALLEGED THAT THERE WAS A PINHOLE IN THE BALLOON OF THE CATHETER. THE PATIENT REPORTEDLY OBTAINED ANOTHER CATHETER AND INSERTED IT WITHOUT ISSUE. NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7452955 ↗