Bardia® All-Silicone Foley Catheter 806516Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00801741039171), received between Jul 17, 2017 and Nov 13, 2025 — classified as 9 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (6 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 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT CUSTOMER STATED THAT THE CATHETER BALLOON WON'T DEFLATE WHEN THEY ARE TRYING TO REMOVE THE CATHETER FROM THE BLADDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23541955 ↗
• MalfunctionOct 17, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE CUSTOMER STATED 3 OF THE CATHETERS IN THE LAST ORDER HAD A HOLE IN THE BALLOON AND THEY ARE ASKING FOR US TO SEND REPLACEMENT CATHETERS OUT TO THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23322319 ↗
• MalfunctionSep 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A COMPLAINT FROM A PATIENT STATING THAT FOLEY'S CATHETERS RECEIVED WERE DEFECTIVE. THE FOLEY WAS LEAKING WHERE IT CONNECTS TO THE BAG. LOT NUMBER WAS NOT AVAILABLE DUE TO THROWING AWAY PACKAGING AFTER OPENING. THEY WERE EXPERIENCED ISSUES WITH 2 FOLEY CATHETER AND THEY HAVE ONE UNOPENED PRODUCT ON HAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23095864 ↗
• MalfunctionSep 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT PATIENT SAID FIRST TIME ONE FOLEY CATHETER WAS LEAKED. IT WAS UNCLEAR IF LOT NUMBER WAS REQUESTED. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22938341 ↗
• MalfunctionFeb 6, 2025Material Invagination; Material Invagination

  IT WAS REPORTED THAT THEY WERE WRITING TO INFORM THAT A PATIENT OF THEIRS RECENTLY RECEIVED AND WAS UNABLE TO USE IT DUE TO THE BALLOON BEING RIBBED (PCN#165816). THEY ATTEMPTED TO SEND ANOTHER OPTION AND FOUND OUT AFTER CALLING THEIR MEDICAL INFORMATION DEPARTMENT, THAT ALL BARD SILICONE FOLEY CATHETERS CAME WITH A RIBBED BALLOON (PCN #806516) AND CONFIRMED THAT THIS DETAIL WAS MISSING. THIS SPECIFIC DETAIL WAS NOT LISTED ONLINE OR THE CATALOG INFORMATION AND WAS AN IMPORTANT FACTOR THAT SHOULD BE NOTATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21321526 ↗
• MalfunctionApr 4, 2024Material Puncture/Hole; Material Rupture; Material Puncture/Hole; Material Rupture

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON WAS NOT HOLDING ANY FLUID, STATED THAT THE CATHETER WAS PLACED TUESDAY AND WAS LEAKING BY THURSDAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19039954 ↗
• MalfunctionOct 13, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT THESE FOLEY CATHETERS WERE LEAKING AND ALSO DID NOT RECEIVE CATHETERS ON LAST ORDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15598601 ↗
• MalfunctionOct 13, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THESE FOLEY CATHETERS WERE LEAKING AND ALSO DID NOT RECEIVE CATHETERS ON LAST ORDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15596919 ↗
• MalfunctionSep 23, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT BOTH FOLEY CATHETER BALLOONS HAD HOLES WHEN BLOWN UP AND THE PATIENT LEAKED EVERYWHERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15469753 ↗
• MalfunctionMay 7, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE FOLEY CATHETER SEPARATED FROM THE BULB AND CAME OUT OF THE SUPRAPUBIC CATHETER. IT WAS STATED THAT THE PATIENT DROVE TO THE EMERGENCY ROOM, SO THE WHOLE WOULD NOT CLOSE. THE PATIENT JUST REPLACED THE DEFECTIVE LEG BAGS BECAUSE THEY WERE LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14316703 ↗
• MalfunctionMay 6, 2022Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE FOLEY CATHETER CAME OUT WHILE PATIENT WAS IN BED AND SEEN BLOOD. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 14304340 ↗
• MalfunctionSep 17, 2021Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE PATIENT IRRIGATED THE FOLEY CATHETER 3 TIMES A DAY AND AFTER A WHILE THE END OF THE FOLEY CATHETER WAS LOOSENED. IT WAS STATED THAT THE LEAKAGE HAPPENED WHEN THE PATIENT RECONNECTED IT BACK TO THE BAG. THE PATIENT ALSO STATED THAT THE LEG STRAPS ON THE BAG LOOSENED AFTER A WHILE AND DID NOT HOLD UP THE BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12487932 ↗
• MalfunctionMay 12, 2021Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE SILICONE FOLEY CATHETER HAD COME OUT FROM PATIENT ON (B)(6) 2021, AS IT WAS INSTALLED ON (B)(6) 2021 WITH 10 ML STERILE WATER. CUSTOMER FURTHER STATED THAT THE CUSTOMER EVEN PULLED IT BACK AGAINST THE BLADDER WALL TO ASCERTAIN IT WAS FIRMLY IN PLACE. PER FOLLOW UP ON (B)(6) 2021, CUSTOMER STATED THAT THE BALLOON WAS TOTALLY DEFLATED ON EXIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11812370 ↗
• MalfunctionApr 23, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE CATHETER BALLOON KEPT POPPED. PER FOLLOW UP ON 07MAY2021, AND 10MAY2021, CUSTOMER REPORTED THAT 2 OR 3 CATHETERS THAT POPPED. CUSTOMER WOULD RETURN ONE CATHETER FOR EVALUATION. NO HARM OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11717442 ↗
• MalfunctionNov 26, 2020Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE BALLOON POPPED AND THE CATHETER CAME OUT. THE CATHETERS WERE FAILED AND DID NOT LAST A MONTH. THE EVENT HAD HAPPENED IN ABOUT 18 TO 22 DAYS IN THE MONTH. PER FOLLOW UP INFORMATION RECEIVED ON 05NOV2020 THE BALLOON INFLATED WITH 8 ML SALINE. ALSO THE CUSTOMER NOTED THAT THE BALLOON ON THE CATHETERS POPPED ON THEIR OWN AFTER 3 WEEKS OF USE. NO MISSING PIECES WERE OBSERVED.

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

  MAUDE report 10909635 ↗
• MalfunctionOct 30, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE SILICONE FOLEY HAD ISSUE WITH RIDGES OR CUFFING AT THE BALLOON AREA, RESULTING IN SOME DISCOMFORT. NO MEDICAL INTERVENTION WAS REPORTED. THE BALLOON APPARENTLY RUPTURED AND SLID OUT WITHOUT KNOWING. THE PATIENT STATED THAT, NORMAL FLOW WAS NOTICED ONCE THE SYRINGE HAS ATTACHED AND WAS NEVER ALLOWED THE AMOUNT OF SUGGESTED TIME OF THE PROCEDURE AND INSTRUCTED TO CUT THE VALVE OFF AND THE SYRINGE WAS NOT HAVE THE FREE MOVEMENT. PER ADDITIONAL INFORMATION RECEIVED ON 17SEP2020, AT THE TIME OF IT'S REMOVAL, IT WAS THE FIRST ONE EVER NOTICED WHICH LOOKED AS IF IT HAD A O RING ON IT. THAT HAS GRADUALLY MIGRATED BACK TOWARDS THE MORE FLUTED POSITION. IN ORDER TO PRODUCE THAT O RING EFFECT IT APPEARS THE FLUTE SOMEHOW ROLLED BACKWARDS. PER ADDITIONAL INFORMATION VIA EMAIL ON 06OCT2020,THE COMPLAINANT STATED THAT THEY ALLOWED THE SYRINGE TO FILL ON IT'S OWN. THEY WAITED FOR SEVERAL MINUTES ,SELF FILL STOPPED AT 7ML AND USER PULLED ON IT BUT COULD REMOVE ONLY 5ML. AND ALSO STATED THAT THEY LOOKED CLOSELY IT APPEARS LIKE THERE WAS A BUILDUP OF PERHAPS CALCIUM.

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

  MAUDE report 10766597 ↗
• MalfunctionOct 30, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE SILICONE FOLEY HAD ISSUE WITH RIDGES OR CUFFING AT THE BALLOON AREA, RESULTING IN SOME DISCOMFORT. NO MEDICAL INTERVENTION WAS REPORTED. THE BALLOON APPARENTLY RUPTURED AND SLID OUT WITHOUT KNOWING. THE PATIENT STATED THAT, NORMAL FLOW WAS NOTICED ONCE THE SYRINGE HAS ATTACHED AND WAS NEVER ALLOWED THE AMOUNT OF SUGGESTED TIME OF THE PROCEDURE AND INSTRUCTED TO CUT THE VALVE OFF AND THE SYRINGE WAS NOT HAVE THE FREE MOVEMENT. PER ADDITIONAL INFORMATION RECEIVED ON 17SEP2020, AT THE TIME OF IT'S REMOVAL, IT WAS THE FIRST ONE EVER NOTICED WHICH LOOKED AS IF IT HAD A O RING ON IT. THAT HAS GRADUALLY MIGRATED BACK TOWARDS THE MORE FLUTED POSITION. IN ORDER TO PRODUCE THAT O RING EFFECT IT APPEARS THE FLUTE SOMEHOW ROLLED BACKWARDS. PER ADDITIONAL INFORMATION VIA EMAIL ON (B)(6) 2020,THE COMPLAINANT STATED THAT THEY ALLOWED THE SYRINGE TO FILL ON IT'S OWN. THEY WAITED FOR SEVERAL MINUTES ,SELF FILL STOPPED AT 7ML AND USER PULLED ON IT BUT COULD REMOVE ONLY 5ML. AND ALSO STATED THAT THEY LOOKED CLOSELY IT APPEARS LIKE THERE WAS A BUILDUP OF PERHAPS CALCIUM.

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

  MAUDE report 10766498 ↗
• MalfunctionOct 14, 2020Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE SILICONE FOLEY HAD ISSUE WITH RIDGES OR CUFFING AT THE BALLOON AREA, RESULTING IN SOME DISCOMFORT. NO MEDICAL INTERVENTION WAS REPORTED. THE BALLOON APPARENTLY RUPTURED AND SLID OUT WITHOUT KNOWING. THE PATIENT NOTICED THERE WAS A NORMAL FLOW ONCE THE SYRINGE WAS ATTACHED AND NEVER ALLOWED THE TIME SUGGESTED FOR THE PROCEDURE. IT WAS THEN INSTRUCTED TO CUT THE VALVE OFF AND THE SYRINGE DID NOT HAVE A FREE MOVEMENT.

  Patient problems: Discomfort

  MAUDE report 10680379 ↗
• MalfunctionOct 9, 2020Material Invagination; Material Invagination

  IT WAS REPORTED THAT THE SILICONE FOLEY HAD ISSUE WITH RIDGES OR CUFFING AT THE BALLOON AREA, RESULTING IN SOME DISCOMFORT. NO MEDICAL INTERVENTION WAS REPORTED. THE BALLOON APPARENTLY RUPTURED AND SLID OUT WITHOUT KNOWING. THE PATIENT NOTICED THERE WAS A NORMAL FLOW ONCE THE SYRINGE WAS ATTACHED AND NEVER ALLOWED THE TIME SUGGESTED FOR THE PROCEDURE. IT WAS THEN INSTRUCTED TO CUT THE VALVE OFF AND THE SYRINGE DID NOT HAVE A FREE MOVEMENT. ADDITIONAL INFORMATION RECEIVED ON 17SEP2020, INDICATED THAT THERE WAS A O RING NOTICED DURING THE TIME OF REMOVAL AND IT GRADUALLY MIGRATED BACK TOWARDS THE MORE FLUTED POSITION. ALSO SUGGESTED THAT TO PRODUCE THAT O RING EFFECT, IT APPEARS THE FLUTE SOMEHOW ROLLED BACKWARDS.

  Patient problems: Discomfort

  MAUDE report 10656470 ↗
• MalfunctionSep 23, 2020Decrease in Pressure; Device Slipped; Decrease in Pressure

  IT WAS REPORTED THAT THE CATHETER PULLED OUT EASILY AND THE USER WENT TO A CLINIC TO GET THE ISSUE FIXED.

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

  MAUDE report 10577101 ↗
• MalfunctionSep 14, 2020Burst Container or Vessel; Leak/Splash; Material Rupture; Burst Container or Vessel

  IT WAS REPORTED THAT THE BALLOON RUPTURED COMPLETELY AND LEAKED WITH 24 TO 72 HOURS OF INSERTION.

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

  MAUDE report 10528458 ↗
• InjurySep 9, 2020Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility

  IT WAS REPORTED THAT THE TWO DIFFERENT PATIENTS DEVELOPED URINARY TRACT INFECTIONS DUE TO FOLEY CATHETER CHANGE AND AN ANOTHER PATIENT DEVELOPED URINARY TRACT INFECTION DUE TO SUPRAPUBIC CATHETER CHANGE, ALSO ANOTHER PATIENT DEVELOPED URINARY TRACT INFECTION DURING IN-AND-OUT CATHETERIZATION FOR ROUTINE URINE SAMPLE. NO MEDICAL INTERVENTION WAS REPORTED. PER FOLLOW UP INFORMATION RECEIVED ON 24AUG2020, THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS.

  Patient problems: Urinary Tract Infection

  MAUDE report 10508094 ↗
• InjurySep 9, 2020Biocompatibility; Insufficient Device Problem Information; Biocompatibility

  IT WAS REPORTED THAT THE TWO DIFFERENT PATIENTS DEVELOPED URINARY TRACT INFECTIONS DUE TO FOLEY CATHETER CHANGE AND AN ANOTHER PATIENT DEVELOPED URINARY TRACT INFECTION DUE TO SUPRAPUBIC CATHETER CHANGE, ALSO ANOTHER PATIENT DEVELOPED URINARY TRACT INFECTION DURING IN-AND-OUT CATHETERIZATION FOR ROUTINE URINE SAMPLE. NO MEDICAL INTERVENTION WAS REPORTED. PER FOLLOW UP INFORMATION RECEIVED ON 24AUG2020, THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS.

  Patient problems: Urinary Tract Infection

  MAUDE report 10508078 ↗
• InjurySep 9, 2020Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility

  IT WAS REPORTED THAT THE TWO DIFFERENT PATIENTS DEVELOPED URINARY TRACT INFECTIONS DUE TO FOLEY CATHETER CHANGE AND AN ANOTHER PATIENT DEVELOPED URINARY TRACT INFECTION DUE TO SUPRAPUBIC CATHETER CHANGE, ALSO ANOTHER PATIENT DEVELOPED URINARY TRACT INFECTION DURING IN-AND-OUT CATHETERIZATION FOR ROUTINE URINE SAMPLE. NO MEDICAL INTERVENTION WAS REPORTED. PER FOLLOW UP INFORMATION RECEIVED ON 24AUG2020, PATIENT WAS NOT GIVEN ANY ANTIBIOTICS AND JUST THE CATHETER WAS CHANGED; HENCEFORTH TREATED BY CHANGING CATHETER.

  Patient problems: Urinary Tract Infection

  MAUDE report 10508068 ↗
• InjurySep 9, 2020Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility

  IT WAS REPORTED THAT THE TWO DIFFERENT PATIENTS DEVELOPED URINARY TRACT INFECTIONS DUE TO FOLEY CATHETER CHANGE AND AN ANOTHER PATIENT DEVELOPED URINARY TRACT INFECTION DUE TO SUPRAPUBIC CATHETER CHANGE, ALSO ANOTHER PATIENT DEVELOPED URINARY TRACT INFECTION DURING IN-AND-OUT CATHETERIZATION FOR ROUTINE URINE SAMPLE. NO MEDICAL INTERVENTION WAS REPORTED. PER FOLLOW UP INFORMATION RECEIVED ON 24AUG2020, THE PATIENT WAS HOSPITALIZED AND URINARY TRACT INFECTION WAS TREATED WITH ANTIBIOTICS VIA INTRA VENOUS.

  Patient problems: Urinary Tract Infection

  MAUDE report 10508056 ↗