Bardia® Foley Catheter Silicone Coated 123526ARecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741095146), received between Jul 16, 2018 and Feb 11, 2025 — classified as 4 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 11, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CUSTOMER INQUIRED IF FOLEY CATHETER 123526A COME IN A LARGER SIZE. THE PATIENT WAS UTILIZING 123526A FOR SUPRAPUBIC DRAINAGE. CUSTOMER ADVISED AFTER REPLACEMENT ON (B)(6) 2025, THE FOLEY WAS LEAKING WHICH PROMPTED THEM TO VISIT THE EMERGENCE ROOM TO STOP THE LEAKING AND QUITE UNCOMFORTABLE. CUSTOMER ADVISED FOLEY WAS CHANGED EVERY FOUR WEEKS AT THE PATIENT UROLOGIST OFFICE. CUSTOMER CONCERNED A LARGER SIZE WAS NEEDED OR IT WAS NOT PROPERLY INSERTED AT THE UROLOGIST OFFICE. ADVISED CUSTOMER THE LARGER SIZE 28FR (123528A) WAS A VIABLE PRODUCT NUMBER. ADVISED TO CONTACT UROLOGIST TO MADE THEM AWARE OF LEAKAGE AND EMERGENCE ROOM VISIT AS UROLOGIST WILL DECIDE IF ANOTHER SIZE WAS NEEDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort

  MAUDE report 21356090 ↗
• MalfunctionFeb 7, 2025Fluid/Blood Leak; Inadequacy of Device Shape and/or Size; Fluid/Blood Leak; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT CUSTOMER CALLED TO INQUIRE IF FOLEY CATHETER CAME IN A LARGER SIZE. THE PATIENT WAS UTILIZING CATHETER FOR SUPRAPUBIC DRAINAGE. CUSTOMER ADVISED AFTER REPLACEMENT ON (B)(6) 2025, THE FOLEY WAS LEAKING WHICH PROMPTED THEM TO VISIT THE EMERGENCY ROOM TO STOP THE LEAKING AND QUITE UNCOMFORTABLE. CUSTOMER ADVISED FOLEY WAS CHANGED (REPLACED) EVERY FOUR WEEKS AT THE PATIENT'S UROLOGIST OFFICE. LIBERATOR WAS THEIR MEDICAL SUPPLY COMPANY. CUSTOMER CONCERNED A LARGER SIZE WAS NEEDED OR IT WAS NOT PROPERLY INSERTED AT THE UROLOGIST OFFICE. REPRESENTATIVE ADVISED CUSTOMER THE LARGER SIZE 28FR (123528A) WAS A VIABLE PRODUCT NUMBER. ADVISED TO CONTACT UROLOGIST TO MAKE THEM AWARE OF LEAKAGE AND EMERGENCY ROOM VISIT AS UROLOGIST WOULD DECIDE IF ANOTHER SIZE WAS NEEDED. NO MEDICAL INTERVENTION WAS REPORTED. PER FOLLOW UP VIA PHONE ON 18FEB2025, IT WAS REPORTED THAT THE CUSTOMER DID VISIT THE UROLOGIST AND WAS ADVISED THAT THE FOLEY CATHETERS WERE NOT THE CAUSE OF THE LEAKING ISSUE. UROLOGIST INFORMED CUSTOMER THAT THEIR BLADDER WAS SMALLER THAN NORMAL, AND SOMETIMES IT DIRECTED THE URINE TO THE STOMACH INSTEAD OF THE FOLEY CATHETER WHICH WOULD ALLOW IT TO DRAIN INTO THE BAG.

  Patient problems: Discomfort

  MAUDE report 21332859 ↗
• InjuryDec 30, 2024Partial Blockage; Adverse Event Without Identified Device or Use Problem; Partial Blockage; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CRITICAL CARE NURSES REPORTED IN AN ONLINE SURVEY THAT THE PATIENT EXPERIENCED ADVERSE EVENTS URINE RETENTION DIRECTLY CAUSED ATTRIBUTABLE TO USAGE OF THE DEVICE BARDIA SILICONE ELASTOMER COATED LATEX 2-WAY, 10ML FOLEY CATHETER, 26 FR. AND RESULTED IN PATIENT INJURY AND REQUIRED THE FOLLOWING MEDICAL OR SURGICAL INTERVENTION FLUSHED. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 06JAN2025, IT WAS REPORTED THAT THE NURSE ALSO INDICATED BLOCKAGE WAS EXPERIENCED AFTER PLACEMENT OF THE DEVICE AND INDICATED THIS WAS A PROCEDURE RELATED COMPLICATION. THOUGH THE NURSE INDICATED THIS TO BE A PROCEDURE COMPLICATION, THEY WERE INDICATING THE DEVICE ITSELF WAS BLOCKED.

  Patient problems: Urinary Retention

  MAUDE report 21035170 ↗
• MalfunctionApr 6, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE FOLEY CATHETERS WERE LEAKING FROM THE BULB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16691156 ↗
• MalfunctionJan 24, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT 10 OF THE FOLEY CATHETERS INSIDE THE BOX HAD PROBLEMS WITH THE BALLOON. IT WAS STATED THAT THE FOLEY BALLOON POPPED EVERY DAY, AND LOTS OF THEM WERE TWO A DAY. THE EVENT HAPPENED MANY TIMES WITH THE TUBES THE PATIENT GETS, AND THE PATIENTS EXPERIENCED SKIN BREAKDOWN FROM LEAKAGE AROUND THE STOMA. NO MEDICAL INTERVENTION WAS REPORTED. PER FOLLOW-UP INFORMATION RECEIVED VIA PHONE ON 18JAN2022, IT WAS STATED THAT THERE WAS NO FURTHER IMPACT TO THE PATIENT.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 13338631 ↗
• InjuryDec 7, 2020Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED THE URINARY TRACT INFECTION CAUSED BY THE CATHETER. IT IS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR THE URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 10959253 ↗
• MalfunctionOct 16, 2020Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE CATHETER BALLOON BURST WAS NOTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10689164 ↗
• MalfunctionAug 28, 2020Defective Device; Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE FOLEY CATHETERS WERE DEFECTIVE.

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

  MAUDE report 10469168 ↗
• MalfunctionApr 9, 2020Partial Blockage; Complete Blockage; Partial Blockage

  IT WAS REPORTED THAT THE PATIENT SAID HE HAD BLOOD CLOTS THAT WERE CLOGGING THE CATHETER.

  Patient problems: No Consequences Or Impact To Patient; Thrombus

  MAUDE report 9945346 ↗
• MalfunctionDec 5, 2019Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE PATIENT STATED THE BALLOON WOULD NOT FILL UP. NO PATIENT INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9416046 ↗
• InjurySep 16, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED UTIS WITH USE OF THE CATHETERS.

  Patient problems: Urinary Tract Infection

  MAUDE report 9071131 ↗
• MalfunctionJul 16, 2018Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE BALLOON OF THE CATHETER BURST WHILE INSIDE THE PATIENT. THERE WAS NO INJURY TO THE PATIENT AND THERE WERE NO PIECES OF THE BALLOON MISSING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7691569 ↗