Bardia® Foley Catheter Silicone Coated 123612ARecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741095177), received between Sep 16, 2020 and Aug 3, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Inaccurate Flow Rate” (4 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.

• MalfunctionAug 3, 2026Inaccurate Flow Rate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50124264 ↗
• InjuryAug 3, 2026Difficult to Remove

  Patient problems: Insufficient Information

  MAUDE report 50124254 ↗
• MalfunctionAug 18, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT 07B UROLOGY PATIENT, HOSPITALIZATION NUMBER: (B)(6), WAS ADMITTED ON (B)(6) 2025, FULLY CONSCIOUS, DUE TO INABILITY TO URINATE INDEPENDENTLY. AS PER MEDICAL ADVICE, A URINARY FOLEY CATHETER WAS INSERTED AT 20:50 ON (B)(6) 2025. THE CATHETER WAS PATENT AND SECURED, AND RELEVANT PRECAUTIONS WERE COMMUNICATED TO THE PATIENT AND FAMILY. ON (B)(6) 2025, AT 19:00, THE FAMILY REPORTED THAT THE CATHETER CAME OUT BY ITSELF AFTER THE PATIENT WENT TO THE BATHROOM. IT WAS IMMEDIATELY CHECKED THE PATIENT BY THE BEDSIDE; THE PATIENT DID NOT REPORT ANY SPECIAL DISCOMFORT AND PROMPTLY NOTIFIED THE DOCTOR TO EXAMINE THE PATIENT. UPON CHECKING THE CATHETER, IT WAS FOUND THAT THE BALLOON AT THE FOREFRONT WAS DAMAGED AND INCOMPLETE. AFTER ASSESSING THE URETHRAL OPENING, NO OBVIOUS INJURIES OR BLEEDING WERE OBSERVED. FOLLOWING MEDICAL ADVICE, THE PATIENT'S URINATION WAS FURTHER MONITORED. AT 21:20, THE PATIENT STILL HAD NOT URINATED. THE DOCTOR ADMINISTERED RE-CATHETERIZATION AND PLACED A DOUBLE-LUMEN CATHETER SIZE 10, CONTINUING TO MONITOR CHANGES IN THE PATIENT'S CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22827000 ↗
• MalfunctionOct 8, 2024Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT INDWELLING FOLEY CATHETER SIZE 12 WAS INSERTED AT 7AM, AND CHANGED AT 12PM. TOTAL DRAINAGE WAS 250ML, WITH AT LEAST 2L OF INTRAVENOUS AND ORAL FLUIDS GIVEN. AFTER CHANGING TO SIZE 14, TOTAL OUTPUT DRAINAGE WAS 250MLS WITHIN THE FIRST 2 HOURS OF REINSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20396881 ↗
• MalfunctionSep 6, 2024Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT PATIENT FOUND HAVING FULL BLADDER PRIOR TO SURGERY DESPITE HAVE A FOLEY CATHETER INSERTED. THE RETENTION AMOUNT RANGED FROM 800 TO 1000MLS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20157792 ↗
• MalfunctionNov 1, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS INSERTED ON (B)(6) 2022. ON (B)(6) 2022, PATIENT INFORMED DOCTOR ABOUT THE LEAKING AND ORDERED TO CHANGE THE URINARY FOLEY CATHETER. WHEN ASPIRATING WATER FROM THE BALLOON IT WAS FOUND THAT THE BALLOON OF THE CATHETER HAD RUPTURED AS THE BACKFLOW FROM THE BALLOON WAS YELLOW COLOR LIKE THE URINE COLOR. NURSE WAS ABLE TO REMOVE THE CATHETER FROM THE PATIENT AND REINSERTED A NEW FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15708441 ↗
• MalfunctionSep 16, 2020Contamination; Inaccurate Flow Rate; Obstruction of Flow; No Flow; Inaccurate Flow Rate

  IT WAS REPORTED THAT THERE WAS NO URINE FLOW WHEN THE NURSE INSERTED CATHETER INTO PATIENT. IT WAS ALSO STATED THAT IT WAS ATTEMPTED TWICE BEFORE OPENING ANOTHER PIECE AND THE CATHETER COULD BE OBSTRUCTED AS FEEDBACK. FOLEY CATHETER WAS CONTAMINATED WITH URINE AND BLOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10542148 ↗