Bardia® Foley Catheter Silicone Coated 123524ARecalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00801741095139), received between Jul 12, 2017 and Jun 10, 2024 — classified as 5 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (5 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 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY URINARY CATHETER LEAKAGE AND SLIPPAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19497489 ↗
• MalfunctionOct 16, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE CUSTOMER ALWAYS TESTED BEFORE BEING PUT IN. BALLOON IN THE LATEX FOLEY CATHETER WOULD NOT DEFLATE. CUSTOMER HAS BEEN USING FOR 9 YEARS AND WAS HAVING THE ISSUE FOR THE FOURTH TIME. THEY WERE CALLING FOR THE FIRST TIME TO COMPLAINT. PER FOLLOW-UP INFORMATION RECEIVED ON 10OCT2023, THE REPORTED ISSUE OCCURRED WITH VARIOUS LOTS, 4 OCCURRENCES, OVER A 6 YEAR PERIOD. NO MEDICAL INTERVENTION WAS NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17939097 ↗
• MalfunctionOct 16, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE CUSTOMER ALWAYS TESTED BEFORE BEING PUT IN. BALLOON IN THE LATEX FOLEY CATHETER WOULD NOT DEFLATE. CUSTOMER HAS BEEN USING FOR 9 YEARS AND WAS HAVING THE ISSUE FOR THE FOURTH TIME. THEY WERE CALLING FOR THE FIRST TIME TO COMPLAINT. PER FOLLOW-UP INFORMATION RECEIVED ON 10OCT2023, THE REPORTED ISSUE OCCURRED WITH VARIOUS LOTS, 4 OCCURRENCES, OVER A 6 YEAR PERIOD. NO MEDICAL INTERVENTION WAS NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17938716 ↗
• MalfunctionMay 13, 2022Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT LAST ONE FOLEY CATHETER FAILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14401336 ↗
• MalfunctionSep 6, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE FOLEY CATHETER DID NOT DEFLATE FOR REMOVAL AFTER INFLATED INTO THE PATIENT. IT WAS NOTED THAT THE EMERGENCY ROOM VISIT WAS REQUIRED TO REMOVE THE CATHETER. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12426928 ↗
• MalfunctionAug 9, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE FOLEY CATHETER DID NOT WORK PROPERLY AS THE BALLOON WOULD NOT DEFLATE ONCE IN THE BLADDER AND THEY HAD TO GO TO THE EMERGENCY ROOM. THE EMERGENCY ROOM DOCTOR FELT THE REASON THE BALLOON DID NOT DEFLATE WAS A DEFECT IN THE SYRINGE PORT. NO MEDICAL INTERVENTION WAS REPORTED. PER CUSTOMER CONTACT VIA PHONE ON (B)(6) 2021, IT WAS STATED THAT THE FOLEY BALLOON WOULD NOT DEFLATE AS NORMAL. IT WAS STATED THAT THE VALVE WOULD NOT ALLOW THE SALINE TO RETURN TO THE SYRINGE AND THEY HAD TO TAKE THE PATIENT TO THE EMERGENCY DEPARTMENT AND THE EMERGENCY SURGEON HAD TO REMOVE THE FOLEY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12293967 ↗
• MalfunctionJul 30, 2021Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE BARDIA CATHETERS WAS GETTING BLOCKED UP AND CAUSING PROBLEMS MAKING THE PATIENT TO RUN OUT OF CATHETERS SOONER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12252739 ↗
• MalfunctionOct 23, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT HAD RECEIVED 3 DEFECTIVE FOLEY CATHETERS. ALL OF THEM LEAKED. ALSO STATED THAT THEY LEAKED BY WHERE THE FOLEY CONNECTED TO THE BAG.

  Patient problems: No Patient Involvement

  MAUDE report 10731330 ↗
• MalfunctionOct 9, 2020Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE BALLOON WAS IN THE MIDDLE OF THE FOLEY CATHETER,SO THE PATIENT COULD NOT USE IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10659001 ↗
• MalfunctionSep 21, 2020Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEAKING. ALSO THE PATIENT STATED THAT THE DOCTOR INCREASED THE FRENCH SIZE. PER FOLLOW UP ON 3FEB2021, VIA PHONE. PATIENT STATED THAT THE DOCTOR INCREASED THE FRENCH SIZE AND WAS EXPERIENCING LEAKING AND THE PATIENT WAS ASKED TO CONTACT THE DOCTOR AND ADJUST THE SIZE.

  Patient problems: Insufficient Information; No Consequences Or Impact To Patient

  MAUDE report 10563996 ↗
• InjurySep 14, 2020Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility

  IT WAS REPORTED THAT THE FOLEY CATHETER CAUSED THE PATIENT TO GET URINARY TRACT INFECTION AND THEY WANTED TO USE MEDLINE FOLEY'S CATHETER. IT WAS UNKNOWN THAT WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 10528295 ↗
• MalfunctionAug 14, 2020Material Puncture/Hole; Gas/Air Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THE BALLOON GETS DEFLATED. THE PATIENT STATED THAT THERE MIGHT HAVE BEEN A HOLE IN THE FOLEY CATHETER.

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

  MAUDE report 10410336 ↗
• MalfunctionAug 13, 2020Decrease in Pressure; Material Rupture; Decrease in Pressure

  IT WAS REPORTED THAT THE BALLOON DEFLATED AFTER ONE DAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10404956 ↗
• InjuryJul 7, 2020Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED URINARY TRACT INFECTION AROUND APRIL OR MAY. PATIENT DID NOT SPECIFY THAT IT WAS CAUSED BECAUSE OF THE CATHETERS. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR THE URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 10239819 ↗
• MalfunctionJun 11, 2020Partial Blockage; Partial Blockage; Obstruction of Flow

  IT WAS REPORTED THAT THE CATHETER WAS CLOGGED AND THE PATIENT WAS UNSURE OF THE CAUSE. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 10143335 ↗
• MalfunctionMay 12, 2020Fluid/Blood Leak; Fluid/Blood Leak; Leak/Splash

  IT WAS REPORTED THAT THE FOLEY CATHETER LEAKS BUT STATED THAT IT MIGHT BE BECAUSE THE PATIENT DAMAGED THE VALVE WHEN PUSHED HARD WITH THE SYRINGE.

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

  MAUDE report 10046452 ↗
• MalfunctionApr 29, 2020Inaccurate Flow Rate; Inaccurate Flow Rate; Obstruction of Flow

  IT WAS REPORTED THAT THE PATIENT STATED HIS FOLEY WAS NOT DRAINING PROPERLY.

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

  MAUDE report 10011654 ↗
• MalfunctionApr 28, 2020Misassembled; Misassembled; Obstruction of Flow

  IT WAS REPORTED THAT ONE OF THE FOLEYS WAS OBSTRUCTED, THE EYELET WAS SMALLER THAN OTHERS.

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

  MAUDE report 10005981 ↗
• MalfunctionApr 27, 2020Partial Blockage; Partial Blockage; Complete Blockage

  IT WAS REPORTED THAT THE PATIENT¿S AUTHORIZED SON STATED THAT SOMETIMES THE PATIENT GOES THROUGH THE CATHETERS MUCH FASTER BECAUSE THEY GET CLOGGED OR BLOCKED OFF WITH SEDIMENT FROM HIS URINE.

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

  MAUDE report 10001802 ↗
• InjuryApr 25, 2020Biocompatibility; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED A URINARY TRACT INFECTION WITH USE OF THE CATHETERS. IT IS UNKNOWN WHAT MEDICAL INTERVENTIONS WERE GIVEN FOR THE UTI.

  Patient problems: Urinary Tract Infection

  MAUDE report 9999053 ↗
• MalfunctionOct 16, 2019Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT UPON INSERTION OF THE FOLEY, THE BALLOON PREMATURELY DEFLATED. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9198957 ↗
• MalfunctionJul 2, 2019Incorrect Measurement; Incorrect Measurement; Structural Problem

  IT WAS REPORTED THAT THE CATHETER SEEMED MORE LIKE A 16 FRENCH THAN A 24 FRENCH.

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

  MAUDE report 8754731 ↗
• MalfunctionMay 30, 2019Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE CATHETERS WERE CLOGGED; AS A RESULT THE PATIENT EXPERIENCED SOME SELF LIMITED BLEEDING. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8656158 ↗
• MalfunctionMar 21, 2019Collapse; Collapse

  IT WAS REPORTED THAT ONCE THE BALLOON INFLATED, THE CATHETER COLLAPSED CAUSING AN INACCURATE FLOW RATE. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8440271 ↗
• InjuryMar 19, 2019Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT USED THE BARDIA FOLEY CATHETER. REPORTEDLY, THE PATIENT EXPERIENCED THE "WORST" INFECTION IN 7 YEARS. THE PATIENT ADVISED SHE WOULD FOLLOW-UP WITH HER NURSE PRACTITIONER TO DETERMINE WHICH CATHETERS SHE NEEDS. THE PATIENT WAS TREATED WITH ANTIBIOTICS.

  Patient problems: Unspecified Infection; Urinary Tract Infection

  MAUDE report 8434463 ↗