Bardia® All-Silicone Foley Catheter 806520Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00801741039195), received between Mar 21, 2018 and Nov 20, 2023 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2023Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT FOLEY CATHETER BENDED EASILY, THE SILICONE WAS SOFT. WITH CUSTOMER MOVEMENT IT KINKED, AND IT DID NOT ALLOW THE URINE TO DRAIN, AND ENDED UP EITHER OVERFLOWING OR GOING BACK INTO THEM. THERE HAVE BEEN TIMES WHERE IT ALSO CAME OUT. THEY HAVE BEEN EXPERIENCED THIS EVER SINCE THEY STARTED USING THIS PRODUCT. AS PER FOLLOW UP VIA PHONE ON (B)(6) 2023, IT WAS REPORTED THAT THE CUSTOMER RECEIVED THE WRONG CATHETERS BUT WAS ABLE TO SWITCH THEM OUT VIA CUSTOMER SERVICE AND THE REPLACEMENT CATHETERS WORKED WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18168979 ↗
• MalfunctionNov 15, 2023Deformation Due to Compressive Stress; Material Too Soft/Flexible; Deformation Due to Compressive Stress; Material Too Soft/Flexible

  IT WAS REPORTED THAT FOLEY CATHETER BENDED EASILY, THE SILICONE WAS SOFT. WITH CUSTOMER MOVEMENT IT KINKED, AND IT DID NOT ALLOW THE URINE TO DRAIN, AND ENDED UP EITHER OVERFLOWING OR GOING BACK INTO THEM. THERE HAVE BEEN TIMES WHERE IT ALSO CAME OUT. THEY HAVE BEEN EXPERIENCED THIS EVER SINCE THEY STARTED USING THIS PRODUCT. PER FOLLOW UP VIA PHONE ON 15NOV2023, IT WAS REPORTED THAT THE CUSTOMER RECEIVED THE WRONG CATHETERS BUT WAS ABLE TO SWITCH THEM OUT VIA CUSTOMER SERVICE AND THE REPLACEMENT CATHETERS WORKED WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18138672 ↗
• MalfunctionSep 1, 2021Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT FOLEY CATHETER WOULD NOT STAY ON AND THE PATIENT HAD TO PURCHASE A NEW ONE OUT OF POCKET. PATIENT HAD BEEN USING FOR MORE THAN 90 DAYS. PER CUSTOMER VIA PHONE ON 16NOV2021, STATED THAT ONLY PART OF THE FOLEY BALLOON WOULD NOT INFLATE. THEREFORE, THE FOLEY WOULD NOT STAY INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12407522 ↗
• MalfunctionSep 4, 2020Leak/Splash; Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE CATHETER WAS LEAKING AT THE PORT.

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

  MAUDE report 10495249 ↗
• MalfunctionSep 4, 2020Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak

  IT WAS REPORTED THAT THE FOLEY CATHETERS WERE LEAKING AROUND THE HOLES.

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

  MAUDE report 10495087 ↗
• MalfunctionAug 7, 2020Inadequate Instructions for Healthcare Professional; Device Markings/Labelling Problem; Inadequate Instructions for Healthcare Professional

  IT WAS REPORTED THAT THE FOLEY WAS MISLABELED AS 10ML INSTEAD OF 5ML.

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

  MAUDE report 10380480 ↗
• MalfunctionJul 23, 2019Material Invagination; Material Invagination; Material Deformation

  IT WAS REPORTED THAT THE BALLOON OF THE SILICONE CATHETER MUSHROOMED. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8816381 ↗
• MalfunctionJul 19, 2019Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE BALLOON OF THE FOLEY CATHETER BURST IN THE PATIENTS' BLADDER, CAUSING THE CATHETER TO FALL OUT AND THE PATIENT EXPERIENCED SOME SELF LIMITED BLEEDING. THE PATIENT DID NOT GO TO THE DOCTOR AND THERE WERE NO MISSING PIECES. NO MEDICAL INTERVENTION REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8807057 ↗
• MalfunctionJan 30, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THERE WAS LEAKING AROUND THE FOLEY. THE PATIENT'S HUSBAND REPORTED VIA PHONE ON (B)(6) 2019, THAT THEY WERE UNSURE IF THERE WAS A PROBLEM WITH THE FOLEY ITSELF OR IF THE CNA PLACED IT INCORRECTLY. THEY HAVE SINCE HAD THE FOLEY REPLACED AND HAVE HAD NO ISSUES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8290809 ↗
• MalfunctionDec 21, 2018Break; Break; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CATHETER HAD A SPLIT WHERE IT WAS ATTACHED TO THE DRAIN BAG TUBING; THEREFORE CREATING A URINE LEAK. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 8189733 ↗
• MalfunctionAug 8, 2018Break; Deflation Problem; Device Dislodged or Dislocated; Deflation Problem

  IT WAS REPORTED THAT THE BALLOON OF THE FOLEY CATHETER BURST IN THE PATIENT'S BLADDER AND THE CATHETER TO FELL OUT. THE PATIENT STATED THAT SHE DID NOT GO TO THE DOCTOR AND THERE WERE NO MISSING PIECES. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 7764757 ↗
• MalfunctionAug 3, 2018Deflation Problem; Leak/Splash; Deflation Problem

  IT WAS REPORTED THAT THE CATHETER BALLOON LEAKED AND THE CATHETER "CAME OUT."

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

  MAUDE report 7746404 ↗
• MalfunctionAug 1, 2018Incorrect Measurement; Fitting Problem; Material Integrity Problem; Incorrect Measurement

  IT WAS REPORTED THAT THE INTERIOR WALL ON THE LARGER PORTION OF THE CATHETER WAS TOO THICK; AS A RESULT THE CATHETER WOULD NOT FIT WITHIN THE STATLOCK.

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

  MAUDE report 7739337 ↗
• MalfunctionJul 18, 2018Burst Container or Vessel; Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE BALLOON OF THE FOLEY CATHETER BURST IN THE PATIENT'S BLADDER, CAUSING THE CATHETER TO FALL OUT. THE PATIENT DID NOT GO TO THE DOCTOR AND THERE WERE NO MISSING PIECES. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 7700322 ↗
• MalfunctionJul 18, 2018Burst Container or Vessel; Material Rupture; Unintended Movement; Burst Container or Vessel

  IT WAS REPORTED THAT THE BALLOON OF THE FOLEY CATHETER BURST IN THE PATIENT'S BLADDER, AND CAUSED THE CATHETER TO FALL OUT. THE PATIENT DID NOT GO TO THE DOCTOR AND THERE WERE NO MISSING PIECES. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 7698146 ↗
• InjuryMay 4, 2018Patient-Device Incompatibility; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED BLOOD CLOTS AFTER USE OF THE CATHETER. IT WAS LATER REPORTED, THE COMPLAINANT STATED THAT HIS PREVIOUS CATHETER WAS IN PLACE FOR 8 WEEKS SO HE NEEDED TO REPLACE IT. AFTER HE INSERTED THE NEW CATHETER, THERE WAS A SIGNIFICANT AMOUNT OF BLEEDING AND BLOOD CLOTS COMING FROM HIS PENIS. DUE TO THE BLEEDING, HE WENT TO THE HOSPITAL WHERE HE WAS IN THE EMERGENCY ROOM (ER) FOR APPROXIMATELY 10 HOURS. THE DOCTOR ATTEMPTED TO FLUSH THE CATHETER TO CLEAR THE BLEEDING AND BLOOD CLOTS, HOWEVER THE ISSUE WAS NOT RESOLVED, THEREFORE THE CATHETER WAS REMOVED AND REPLACED. ONCE THE NEW CATHETER WAS INSERTED, THE BLEEDING SUBSIDED AND THERE WERE NO OTHER ISSUES. HE DID RECEIVE INTRAVENOUS FLUID REPLACEMENT DURING HIS ER VISIT.

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

  MAUDE report 7487177 ↗
• MalfunctionMar 21, 2018Failure to Infuse

  IT WAS REPORTED THAT THE CATHETER BALLOON FAILED TO INFLATE UPON PRE-TEST OF THE CATHETER.

  Patient problems: No Patient Involvement

  MAUDE report 7357999 ↗