Bardia® Foley Catheter Silicone Coated 123624ARecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741095238), received between Jul 30, 2018 and Oct 19, 2022 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Decrease in Pressure” (2 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 19, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT THERE ARE SEVERAL MISSING COMPONENTS FROM BARDIA 2-WAY SILICONE-COATED FOLEY CATHETER BOXES. IT WAS REPORTED THAT THE BAGS OR EVEN CATHETERS WERE MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15632781 ↗
• MalfunctionMay 4, 2022Illegible Information; Illegible Information

  IT WAS REPORTED THAT THE EXPIRY DATE WAS UNCLEAR IN THE FOLEY CATHETER AND A NEW CATHETER WAS CHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14281692 ↗
• MalfunctionNov 30, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS DEFECTIVE BECAUSE THE PATIENT WAS WAKING UP WET. IT WAS STATED THAT THE PATIENT COULD NOT AFFORD TO GET WET BECAUSE OF THE PREVIOUS WOUND. IT WAS NOTED THAT THE PATIENT HAD BEEN USING THE PRODUCT FOR MORE THAN 90 DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Skin Inflammation/ Irritation

  MAUDE report 12892086 ↗
• MalfunctionJul 2, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS FOUND TO BE BROKEN. SO, THE CUSTOMER CHANGED A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12108687 ↗
• MalfunctionJan 25, 2021Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE FOLEY CATHETER DID NOT STAY INFLATED.

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

  MAUDE report 11227316 ↗
• MalfunctionJul 29, 2020Deflation Problem; Decrease in Pressure; Device Slipped; Decrease in Pressure

  IT WAS REPORTED THAT AN ISSUE WAS REPORTED AND THE CUSTOMER CAN BE CONTACTED FOR ADDITIONAL INFORMATION. PER FOLLOW UP ON (B)(6) 2020 VIA PHONE TO THE COMPLAINANT. IT WAS REPORTED THAT THE CATHETER FELL OUT OF THE PATIENT WITH THE BALLOON COMPLETELY DEFLATED. THE CATHETER WAS IN USE FOR ABOUT 2 WEEK AND ALSO STATED THAT CATHETER WAS INFLATED WITH 30CC STERILE WATER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10341069 ↗
• InjuryJul 10, 2020Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT GOT URINARY TRACT INFECTION. PATIENT DID NOT SPECIFY IT WAS THE CATHETERS THAT CAUSED THE URINARY TRACT INFECTION. IT WAS UNKNOWN WHAT TYPE OF MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Urinary Tract Infection

  MAUDE report 10258281 ↗
• MalfunctionFeb 12, 2020Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE FOLEY BALLOON FAILED TO INFLATE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9701154 ↗
• MalfunctionFeb 20, 2019Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO VOID AFTER FULLY INSERTING THREE FOLEY CATHETERS. AFTER A FOLLOW UP WITH THE PATIENT'S CAREGIVER, IT WAS REPORTED THAT THREE CATHETERS WERE INSERTED WITH UNSUCCESSFUL URINE RETURN. A FOURTH CATHETER WAS THEN FULLY INSERTED AND THE PATIENT WAS ABLE TO VOID. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8353282 ↗
• MalfunctionAug 27, 2018Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE PATIENT'S URINE DID NOT DRAIN THROUGH THE SUPRAPUBIC FOLEY CATHETER AND INSTEAD LEAKED FROM HER URETHRA. THE PATIENT STATED THAT, AS A RESULT, SHE ALLEGEDLY EXPEREINCED BLADDER SPASMS AND IRRITATION. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Irritation; Muscle Spasm(s)

  MAUDE report 7820558 ↗
• MalfunctionAug 27, 2018Fluid/Blood Leak; Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE FOLEY CATHETER LEAKED WHEN THE "FLUSHED ANCHOR BALLOON" WAS INFLATED.

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

  MAUDE report 7819302 ↗
• MalfunctionJul 30, 2018Inflation Problem; Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON FAILED TO INFLATE WHEN THE NURSE ATTEMPTED TO PUT 10CC OF WATER INTO THE CATHETER INFLATION PORT.

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

  MAUDE report 7731943 ↗