Bardia® All-Silicone Foley Catheter 806316Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00801741039119), received between Jun 7, 2018 and Feb 7, 2025 — classified as 6 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2025Incorrect Measurement; Inadequacy of Device Shape and/or Size; Incorrect Measurement; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE CRITICAL CARE NURSES REPORTED IN AN ONLINE SURVEY THAT THE ALL-SILICONE FOLEY CATHETER, 2-WAY, STANDARD LENGTH, 30CC BALLOON, 16 FR WAS NOT SUCCESSFULLY PLACED IN THE PATIENT BECAUSE OF THE SIZE WAS RATHER BIG. THEY SWAPPED TO PIG TAIL SIZE 8 AND THEN CONNECTED TO SIZE 16CH TUBING. PER ADDITIONAL INFORMATION RECEIVED ON 08MAR2025, IT WAS REPORTED THAT THE COMPLAINT WAS NOT DUE TO DEVICE RELATED FAILURE, BUT THIS OCCURRED DUE TO THE COMPLEXITY OF THEIR CARE NEEDS. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT AS A RESULT OF THE DEVICE. PIG TAIL CATHETER WAS CONSIDERED DUE TO PRESENCE OF BLADDER TUMOR AND PATIENT EXPERIENCING SIGNIFICANT HYDRONEPHROSIS BUT WAS UNFIT FOR SURGERY AT THE TIME. AS URETHRAL CATHETERIZATION FAILED DUE TO BLADDER OUTLET OBSTRUCTION. PIGTAIL CATHETER WAS THEN USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21332852 ↗
• MalfunctionAug 2, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT SPONTANEOUS REMOVAL OF THE FOLEY CATHETER OCCURRED DUE TO RUPTURE OF THE BALLOON CUFF IMMEDIATELY AFTER PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19892286 ↗
• MalfunctionOct 14, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE 30 CC BALLOON WAS LEAKING AND THE PATIENT FELT IT MAYBE TOO BIG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15606930 ↗
• InjuryJun 5, 2020Biocompatibility; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN UPON INSERTION AS THE CATHETER WAS RIBBED. THE PATIENT POSSIBLY DEVELOPING URINARY TRACT INFECTION. NO MEDICAL INTERVENTION REPORTED. IT WAS LATER REPORTED FROM THE CUSTOMER CONTACT VIA PHONE ON 05JUN2020, THE BALLOON ON THE FOLEY CATHETERS WERE RIBBED, SO THEY CAUSED PAIN DURING INSERTION AND REMOVAL. THE CUSTOMER NOTED THAT SHE DEVELOPED A URINARY TRACT INFECTION AS A RESULT OF USING THESE CATHETERS AND WAS PRESCRIBED ANTIBIOTICS.

  Patient problems: Pain; Urinary Tract Infection

  MAUDE report 10122746 ↗
• InjuryMar 11, 2020Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT SAID SHE GOT A UTI, BUT SHE WAS NOT SURE WHAT CAUSED IT. SHE ALSO SAID SHE WAS NO LONGER USING CATHETERS. IT WAS UNKNOWN IF TREATMENT WAS PROVIDED.

  Patient problems: Urinary Tract Infection

  MAUDE report 9819124 ↗
• InjuryJan 9, 2020Break; Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE FOLEY BURST WHILE INSIDE OF THE PATIENT, WHICH CAUSED A UTI. CUSTOMER WAS SEEN BY THE DOCTOR WHO GAVE HER A NEW FOLEY INSERTION TRAY. IT IS UNKNOWN WHAT MEDICAL INTERVENTIONS WERE GIVEN FOR THE UTI.

  Patient problems: Urinary Tract Infection

  MAUDE report 9571598 ↗
• InjuryNov 25, 2019Patient-Device Incompatibility; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED FREQUENT BACTERIAL AND URINARY TRACT INFECTIONS FROM USING THE SILICONE CATHETER. THE PATIENT WAS REPORTEDLY PRESCRIBED WITH ANTIBIOTICS TO TREAT THE INFECTION.

  Patient problems: Bacterial Infection; Unspecified Infection; Urinary Tract Infection

  MAUDE report 9371211 ↗
• MalfunctionMay 29, 2019Difficult to Remove; Inflation Problem; Difficult to Remove

  IT WAS REPORTED THAT THE SILICONE CATHETER WOULD NOT DEFLATE. A UROLOGIST WAS CONTACTED TO REMOVE THE CATHETER SUCCESSFULLY. THE METHOD BY WHICH THE CATHETER WAS REMOVED IS UNKNOWN. NO PATIENT INJURY/MEDICAL INTERVENTION REPORTED.

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

  MAUDE report 8649508 ↗
• MalfunctionMay 28, 2019Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT THE SILICONE CATHETER WOULD NOT DEFLATE. AT THE TIME WHEN THE COMPLAINT WAS REPORTED THE CATHETER HAD NOT BEEN REMOVED. ALL GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN COMPLETED.

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

  MAUDE report 8647713 ↗
• InjuryMay 15, 2019Material Invagination; Therapeutic or Diagnostic Output Failure; Material Invagination

  IT WAS REPORTED THAT THE BALLOON OF THE SILICONE FOLEY CATHETER MUSHROOMED DURING USE MAKING IT DIFFICULT TO REMOVE. PATIENT WAS TAKEN TO THE EMERGENCY ROOM WHERE A UROLOGIST WAS BROUGHT IN TO REMOVE THE CATHETER. THE METHOD OF CATHETER REMOVAL IS UNKNOWN. THE COMPLAINANT IS UNABLE OR UNWILLING TO PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient; Patient Problem/Medical Problem

  MAUDE report 8611681 ↗
• InjuryMay 15, 2019Material Invagination; Difficult to Remove; Deformation Due to Compressive Stress; Material Invagination

  IT WAS REPORTED THAT THE BALLOON OF THE SILICONE FOLEY CATHETER MUSHROOMED DURING USE MAKING IT DIFFICULT TO REMOVE. THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM WHERE A UROLOGIST WAS BROUGHT IN TO REMOVE THE CATHETER. THE METHOD OF THE CATHETER REMOVAL IS UNKNOWN. THE COMPLAINANT IS UNABLE OR UNWILLING TO PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient; Patient Problem/Medical Problem

  MAUDE report 8611677 ↗
• MalfunctionOct 25, 2018Burst Container or Vessel

  IT WAS REPORTED THAT THE BALLOON ON THE FOLEY CATHETER, BURST WHILE IN USE. NO PIECES WERE REPORTED TO BE MISSING AND NO MEDICAL INTERVENTION WAS REQUIRED. THE CATHETER WAS REMOVED AND REPLACED.

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

  MAUDE report 8005307 ↗
• MalfunctionOct 3, 2018Failure to Infuse

  IT WAS REPORTED THAT THE BALLOON OF THE CATHETER FAILED TO INFUSE.

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

  MAUDE report 7930215 ↗
• MalfunctionJul 9, 2018Leak/Splash; Material Puncture/Hole; Leak/Splash

  IT WAS REPORTED THAT THERE WAS A PINHOLE IN THE CATHETER. THE LOCATION OF THE PINHOLE WAS NOT REPORTED.

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

  MAUDE report 7671403 ↗
• MalfunctionJun 7, 2018Difficult to Remove; Mushroomed; Mushroomed

  IT WAS REPORTED THAT WHEN THE NURSE TRIED TO TAKE THE SALINE OUT OF THE BALLOON, THERE WAS ONLY 6ML OF FLUID IN THE BALLOON. THE ARM WAS THEN CUT TO REMOVE THE REMAINING FLUID. THE CATHETER FELT STUCK SO THE PATIENT WENT TO THE DOCTOR TO HAVE IT REMOVED. IT WAS REMOVED BY THE DOCTOR AND ON THE END OF THE CATHETER THERE WAS A "LIP" THAT THE DOCTOR SAID MAY HAVE CAUSED THE CATHETER TO GET CAUGHT UP AND DIFFICULT TO REMOVE.

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

  MAUDE report 7579292 ↗