Bardia® Foley Catheter Silicone Coated 123514ARecalls & reported problems

Summary

The FDA's MAUDE database contains 195 adverse event reports that list this exact device (DI 00801741095085), received between May 10, 2017 and Sep 18, 2026 — classified as 22 injuries, 173 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (29 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 195 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Restricted Flow rate

  Patient problems: Insufficient Information

  MAUDE report 50828910 ↗
• MalfunctionSep 18, 2026Restricted Flow rate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50828900 ↗
• MalfunctionSep 14, 2026Material Rupture

  Patient problems: Exposure to Body Fluids; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50765284 ↗
• MalfunctionAug 11, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50209945 ↗
• InjuryAug 11, 2026Material Invagination

  It was reported that during hygiene cares, green pus discharge was noted around the insertion area. The physician was made aware and an order was received to remove the Foley. The writer deflated and removed 10 mL of sterile water from the balloon, then experienced resistance during removal. Urotech was consulted and came to the floor. The balloon of the Foley malfunctioned (see media photos) and appeared to have a material defect on the balloon wall. When deflated, the balloon had a blister of air remaining. Urotech removed the Foley, and the patient experienced significant pain. Bloody discharge was noted upon removal. Tylenol PRN was administered. The patient was currently stable. The MD was made aware.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 50209296 ↗
• MalfunctionAug 6, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50166667 ↗
• MalfunctionJul 31, 2026Disconnection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50105792 ↗
• MalfunctionJul 31, 2026Disconnection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50105789 ↗
• MalfunctionJul 31, 2026Disconnection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50105788 ↗
• MalfunctionJul 31, 2026Disconnection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50105785 ↗
• MalfunctionJun 19, 2026Material Rupture

  It was reported that recently, there have been frequent reports of Foley catheter balloon ruptures during departmental use, mainly with model 123514C. The department had been using it for years and says there was no problem with their operation. Also please investigate the root cause of the problem to avoid damaging the product¿s reputation within the department.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25566031 ↗
• MalfunctionMay 21, 2026Component Misassembled

  IT WAS REPORTED THAT A URINARY FOLEY CATHETER WAS INSERTED PREOPERATIVELY, BUT NO URINE OUTPUT WAS OBSERVED. THE CATHETER WAS REMOVED FOR INSPECTION AND FLUSHING TEST, WHICH REVEALED THAT THE DISTAL TIP HAD NO OPENING, PREVENTING FLUID FROM DRAINING. THE CATHETER WAS IDENTIFIED AS DEFECTIVE, AND THE ISSUE WAS RESOLVED AFTER REPLACING IT WITH A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25249520 ↗
• MalfunctionApr 30, 2026Nonstandard Device; Component Misassembled

  IT WAS REPORTED THAT THE PATIENT RETURNED TO THE WARD AT 14:51 FOLLOWING SURGERY. A URINARY CATHETER HAD BEEN PLACED INTRAOPERATIVELY; HOWEVER, NO URINE OUTPUT WAS OBSERVED. AFTER EVALUATION BY THE ATTENDING PHYSICIAN AND ASSESSMENT OF INTRAOPERATIVE FLUID LOSS, IT WAS DECIDED TO INCREASE IV FLUID ADMINISTRATION AND CONTINUE MONITORING URINE OUTPUT. AT 18:30, URINE OUTPUT REMAINED ABSENT. THE ON-DUTY PHYSICIAN WAS NOTIFIED, AND THE CATHETER WAS REPLACED. UPON REMOVAL, IT WAS DISCOVERED THAT THE ORIGINAL CATHETER HAD NO OPENING AT THE DISTAL TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25050382 ↗
• MalfunctionApr 21, 2026Material Rupture

  IT WAS REPORTED THAT DURING USE 12 HOURS AFTER PLACEMENT THE FOLEY CATHETER HAD SPONTANEOUSLY DISLODGED DUE TO BALLOON RUPTURE.THE PATIENT WAS ADMITTED FOR URETERAL STENT REPLACEMENT AND THE STENT WAS INSERTED AND PLACED IN THE OPERATING ROOM. CATHETERIZATION WAS PERFORMED WITHOUT ISSUE DURING PLACEMENT. LATER THAT DAY, THE PATIENT PRESSED THE NURSE CALL BUTTON; UPON CHECKING, THE CATHETER HAD SPONTANEOUSLY DISLODGED, AND INSPECTION OF THE BALLOON REVEALED IT WAS RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24943445 ↗
• MalfunctionApr 15, 2026Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON WATER LEAKED DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24890289 ↗
• MalfunctionMar 9, 2026Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT WARD 4 HAS TESTED SEVERAL BEFORE THEY PUT THEM IN, AND THE CUFF CANNOT BE PUSHED OUT SO TO SPEAK, THE EMERGENCY ROOM HAD ALSO PUT ONE IN AND THAT PERSON HAD TO GO UP TO SURGERY AND REMOVE IT AS IT COULD NOT BE PUSHED OUT. UNABLE TO REMOVE LIQUID FROM THE TRUNK WARD 4 HAS TESTED SEVERAL BEFORE THEY PUT THEM IN, AND THE TRUNK CANNOT BE REMOVED SO TO SPEAK, THE EMERGENCY ROOM HAD ALSO PUT ONE IN AND THAT PERSON HAD TO GO UP FOR SURGERY AND REMOVE IT AS IT COULD NOT BE REMOVED. ARE THE PRODUCTS AVAILABLE? NO HAS THERE BEEN ANY PATIENT INVOLVEMENT (SERIOUS INJURY, MEDICAL INTERVENTION, CHANGE OF TREATMENT REQUIRED)? PATIENT HAD TO BE TAKEN UP FOR SURGERY TO REMOVE THE CATHETER.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24553028 ↗
• InjuryMar 9, 2026Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT WARD 4 HAS TESTED SEVERAL BEFORE THEY PUT THEM IN, AND THE CUFF CANNOT BE PUSHED OUT SO TO SPEAK, THE EMERGENCY ROOM HAD ALSO PUT ONE IN AND THAT PERSON HAD TO GO UP TO SURGERY AND REMOVE IT AS IT COULD NOT BE PUSHED OUT. UNABLE TO REMOVE LIQUID FROM THE TRUNK WARD 4 HAS TESTED SEVERAL BEFORE THEY PUT THEM IN, AND THE TRUNK CANNOT BE REMOVED SO TO SPEAK, THE EMERGENCY ROOM HAD ALSO PUT ONE IN AND THAT PERSON HAD TO GO UP FOR SURGERY AND REMOVE IT AS IT COULD NOT BE REMOVED. ARE THE PRODUCTS AVAILABLE? NO. HAS THERE BEEN ANY PATIENT INVOLVEMENT (SERIOUS INJURY, MEDICAL INTERVENTION, CHANGE OF TREATMENT REQUIRED)? PATIENT HAD TO BE TAKEN UP FOR SURGERY TO REMOVE THE CATHETER.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24553027 ↗
• MalfunctionJan 12, 2026Material Rupture

  IT WAS REPORTED THAT DURING USE THE FOLEY CATHETER SLIPPED OUT. UPON INSPECTION, BALLOON HAD A TEAR AND DEFLATED ON ITS OWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24048945 ↗
• MalfunctionJan 7, 2026Inaccurate Flow Rate

  IT WAS REPORTED THAT DURING USE THE FOLEY CATHETER WAS UNABLE TO DRAIN URINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23999400 ↗
• MalfunctionDec 11, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS SPONTANEOUSLY DISLODGED DURING USE AFTER THE STERILE WATER FELL OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23780077 ↗
• MalfunctionDec 10, 2025Naturally Worn; Device Contamination with Chemical or Other Material; Naturally Worn

  IT WAS REPORTED THAT THE TIP OF THE FOLEY CATHETER WAS FRAYED AND UNEVEN REPLACED WITH ANOTHER SET TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23771527 ↗
• MalfunctionDec 10, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT PATIENT FOLEY CATHETER FELL OFF WHEN ASSISTED TO WASHROOM WITHOUT BEEN DEFLATED BY NURSING STAFF. UPON INVESTIGATION, FOLEY CATHETER WAS NOT INFLATED WHEN THAT FELL OFF, AND WHEN NORMAL SALINE WAS ATTEMPTED TO REINFLATE BALLOON, A HOLE WAS SAW ON BALLOON AND KEPT ON SQUIRTING THE NORMAL SALINE OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23771021 ↗
• MalfunctionDec 3, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING USE THE FOLEY CATHETER BALLOON RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23708363 ↗
• MalfunctionNov 11, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT REGISTERED NURSE WAS TESTING PRODUCT PRIOR TO INSERTING FOLEY INTO PATIENT. REGISTERED NURSE INFLATED THE BALLOON WITH THE 10ML PFS AND WHEN DEFLATING BALLOON APPROXIMATELY 1ML NS REMAINED AND BALLOON COULD NOT COMPLETELY DEFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23524808 ↗
• MalfunctionSep 23, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT, 1 DAY AFTER PLACEMENT USER NOTICED FOLEY CATHETER HAD COME LOOSE WHILE WORKING WITH THE PATIENT AND FOUND A CRACK IN THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23123093 ↗