Bardia® All-Silicone Foley Catheter 806518Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00801741039188), received between Jun 13, 2017 and Sep 18, 2026 — classified as 2 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (5 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50819875 ↗
• MalfunctionFeb 18, 2026Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED BY CUSTOMER THAT THEY HAD A DEFECT ON THE PRODUCT, AND THE CATHETER WAS INSERTED ON THE PATIENT AND WITHIN A COUPLE DAYS IT WAS LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24381328 ↗
• MalfunctionSep 4, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON DOES NOT HOLD IT WAS LIKE A FINE MIST, WILL ONLY HOLD FOR 6 TO 8 HOURS BEFORE HAVING TO CHANGE AGAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22963721 ↗
• MalfunctionJun 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CATHETER WAS LEAKING WHILE USING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22132475 ↗
• MalfunctionApr 13, 2022Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE BARDIA SILICONE FOLEY CATHETER BALLOON DEFLATED IN 4 DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14106379 ↗
• MalfunctionSep 21, 2021Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE PATIENT HAD THE SILICONE FOLEY CATHETER BALLOON DEFLATION IN THE MIDDLE OF THE NIGHT AND THE PATIENT WOKE UP WITH WET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12505636 ↗
• MalfunctionAug 26, 2021Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT BARDIA SILICONE FOLEY CATHETER BALLOONS DID NOT INFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12370283 ↗
• MalfunctionJan 27, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT'S URETHRA WAS TEAR FROM USING THE SILICONE FOLEY CATHETER. ALSO, REPORTED THAT THERE WAS SOME BLEEDING BECAUSE THE RIBBED BALLOON WAS TOO BIG. THE PATIENT USED THE 16 FR CATHETER IN THE PAST, BUT WANTED TO TRY A LARGER CATHETER TO HELP IN THE IMPROVEMENT IN DRAINAGE. IT WAS CONFIRMED THAT THE BALLOON WAS NOT PRETESTED PRIOR TO INSERTION TO WHICH, MSS HAD ADVISED THAT PRETESTING THE CATHETER WAS NOT RECOMMENDED AS THIS COULD FORM RIDGES ON THE BALLOON AND CAUSE THE URETHRAL DAMAGE. IT WAS SUGGESTED TO USE A SMALLER SIZE CATHETER AS 18 FR MIGHT BE TOO LARGE. PER FOLLOW-UP VIA PHONE ON 14JAN2021, NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT REPORTEDLY HAD LIGHT BLEEDING FOR A COUPLE OF DAYS AND THEN CLEARED UP. THE CUSTOMER WAS NO LONGER USING THE CATHETERS.

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

  MAUDE report 11236006 ↗
• MalfunctionNov 18, 2020Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS UNCOMFORTABLE AND KEPT COMING OFF. NO SPECIFICS WERE GIVEN. NO MEDICAL INTERVENTION REPORTED.

  Patient problems: Discomfort

  MAUDE report 10864294 ↗
• MalfunctionNov 18, 2020Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE TWO OF THE FOLEY CATHETER HAD PINHOLES IN THE BALLOON.

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

  MAUDE report 10864065 ↗
• MalfunctionSep 1, 2020Burst Container or Vessel

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON HAD EXPLODED. ALSO COMPLAINED OF HAVING TO USE AN OLD ONE.

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

  MAUDE report 10477558 ↗
• MalfunctionMay 13, 2020Fluid/Blood Leak

  IT WAS REPORTED THAT THE CATHETER LEAKED WITH USE.

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

  MAUDE report 10051305 ↗
• MalfunctionJan 23, 2020Material Rupture

  IT WAS REPORTED THAT THE BALLOON BURST CAUSED IT TO DEFLATE WHILE IN USE. PER ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER VIA PHONE ON (B)(6) 2020, 10CC OF FLUID WAS USED TO INFLATE THE BALLOON AND IT BURST WITHIN A WEEK OF USE. NO PIECES WERE OBSERVED TO BE MISSING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9621470 ↗
• MalfunctionJan 14, 2020Burst Container or Vessel

  IT WAS REPORTED THAT THE BALLOON ON THE FOLEY CATHETER BURST DURING USE. NO PIECES WERE OBSERVED TO BE MISSING, AND THE CUSTOMER NOTED THAT 10CC OF FLUID WAS USED TO INFLATE THE BALLOON.

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

  MAUDE report 9587521 ↗
• MalfunctionJul 31, 2019Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE SILICONE CATHETER LEAKED WATER FROM THE BALLOON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8845135 ↗
• MalfunctionJun 4, 2019Deflation Problem; Deflation Problem; Leak/Splash; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE BALLOON PREMATURELY DEFLATED AND AS A RESULT THE CATHETER FELL OUT OF THE PATIENT. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 8669155 ↗
• MalfunctionMay 30, 2019Difficult to Remove; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AND SELF-LIMITED BLEEDING WHEN REMOVING THE SILICONE CATHETER. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain; Patient Problem/Medical Problem

  MAUDE report 8654574 ↗
• MalfunctionApr 7, 2019Material Invagination; Material Deformation; Material Invagination

  IT WAS REPORTED THAT THE BALLOON OF THE SILICONE CATHETER MUSHROOMED DURING USE. THE PATIENT ALLEGEDLY EXPERIENCED SELF-LIMITED BLEEDING. NO MEDICAL INTERVENTION/PATIENT INJURY REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Patient Problem/Medical Problem

  MAUDE report 8490005 ↗
• InjuryFeb 20, 2019Calcified

  IT WAS REPORTED THAT THE SILICONE FOLEY CATHETER DEVELOPED CALCIFICATION ON THE OUTSIDE. THE PATIENT WENT TO THEIR PHYSICIAN ON (B)(6) 2019 TO HAVE THE CATHETER CHANGED. THE PHYSICIAN HAD TO SEND THE PATIENT TO AN OUT-PATIENT SURGICAL CENTER TO REMOVE THE CATHETER BECAUSE IT WAS TOO PAINFUL.

  Patient problems: Pain

  MAUDE report 8353293 ↗
• MalfunctionFeb 5, 2019Deflation Problem; Fluid/Blood Leak; Deflation Problem

  IT WAS REPORTED THAT THE FOLEY CATHETER LEAKED FROM THE INFLATION PORT.

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

  MAUDE report 8308382 ↗
• MalfunctionOct 16, 2018Burst Container or Vessel

  IT WAS REPORTED THAT THE BALLOON OF THE CATHETER BURST WHILE THE PATIENT WAS SLEEPING. PER THE PATIENT THERE WERE NO PIECES OF THE BALLOON MISSING.

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

  MAUDE report 7970454 ↗
• MalfunctionSep 4, 2018Deflation Problem

  IT WAS REPORTED THAT THE SILICONE FOLEY CATHETER BALLOON DEFLATED AFTER A WEEK AND A HALF OF USE. NO MEDICAL INTERVENTION WAS REQUIRED. ALLEGEDLY THE CATHETER WAS INFLATED WITH 10CC OF WATER.

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

  MAUDE report 7843660 ↗
• MalfunctionJan 5, 2018Component Falling; Deflation Problem

  IT WAS REPORTED THAT THE CATHETER BALLOON DEFLATED AND FELL OUT OF THE PATIENT. THE COMPLAINANT REPORTED THAT THE CATHETER HAD BEEN IN PLACE FOR ONE WEEK PRIOR TO FALLING OUT. THE PATIENT STATED THAT THE BALLOON WAS INTACT UPON REMOVAL AND SHE WAS UNSURE WHETHER THE CATHETER HAD A HOLE OR HAD JUST DEFLATED THROUGH THE PORT. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7167649 ↗
• MalfunctionDec 5, 2017Burst Container or Vessel

  IT WAS REPORTED THE CATHETER BALLOON BUST UPON INFLATION. THE COMPLAINANT ALLEGED THAT THE CATHETER BUSTED AS SOON AS IT WAS PLACED; HOWEVER, THERE WERE NO MISSING PIECES. THE COMPLAINANT ALSO NOTED THAT THE CATHETER WAS REMOVED AND REPLACED WITHOUT FURTHER INCIDENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7082534 ↗
• MalfunctionNov 28, 2017Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE CATHETER WAS DISLODGED FROM THE PATIENT. THE COMPLAINANT REPORTED THAT THE FOLEY BALLOON WAS INTACT AND CONTAINED 3 CC OF STERILE WATER. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7065224 ↗