Bardia® Foley Catheter Silicone Coated 123522ARecalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00801741095122), received between May 26, 2017 and Dec 4, 2025 — classified as 3 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING USE THE FOLEY CATHETER BALLOON RUPTURED, AND CATHETER SLIPPAGE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23717781 ↗
• MalfunctionFeb 4, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT FOLEY CATHETER WOULD NOT STAY AND CONTINUOUSLY POPPED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21303182 ↗
• InjuryJan 3, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE CRITICAL CARE NURSES REPORTED IN AN ONLINE SURVEY THAT THE PATIENT EXPERIENCED ADVERSE EVENTS BACTERIURIA OR URINARY TRACT INFECTION, URINE RETENTION DIRECTLY CAUSED ATTRIBUTABLE TO USAGE OF THE DEVICE BARDIA SILICONE ELASTOMER COATED LATEX 2-WAY, 10ML FOLEY CATHETER, 22 FR. AND RESULTED IN PATIENT INJURY FOLLOWING THIS MEDICAL OR SURGICAL INTERVENTION FOR BACTERIURIA OR URINARY TRACT INFECTION CAUSE PAIN, FOR URINE RETENTION BOLD.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding; Pain; Urinary Tract Infection

  MAUDE report 21068804 ↗
• InjuryDec 31, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE CRITICAL CARE NURSES REPORTED IN AN ONLINE SURVEY THAT THE PATIENT EXPERIENCED ADVERSE EVENTS IRRIGATION, VESICOURETERAL REFLUX, IRRITATION DIRECTLY CAUSED OR ATTRIBUTABLE TO USAGE OF THE DEVICE BARDIA SILICONE ELASTOMER COATED LATEX 2-WAY, 10ML FOLEY CATHETER, 22 FR. AND RESULTED IN PATIENT INJURY FOLLOWING THIS MEDICAL OR SURGICAL INTERVENTION SUTURING.

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

  MAUDE report 21047209 ↗
• MalfunctionAug 22, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING LEAKAGE WITH CURRENT CATHETER 123522A. THEY WANTED TO TRY CATHETER 123516A TO COMPARE THE TWO PRODUCTS. REPRESENTATIVE EXPLAINED THERE SHOULD NOT BE LEAKING AROUND THE FOLEY, ADVISED PATIENT FOLLOW UP WITH PROVIDER REGARDING CHANGING CATHETER SIZE/STYLE. STATED BOTH CATHETERS WERE SILICONE COATED LATEX, BOTH HAD A 5CC BALLOON WITH A16IN LENGTH. INFORMED PATIENT THE CURRENT SIZE THEY WERE USING WAS A 22FR; THE ALTERNATE CATHETER WAS 16FR BUT DID COME IN A 22FR (123522A) IF NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17595441 ↗
• MalfunctionAug 8, 2023Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON HAS POPPED TWICE WHILE IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17481312 ↗
• MalfunctionMay 16, 2022Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  IT WAS REPORTED THAT THE FOLEY CATHETER LOOKED DIRTY AND ONE WAS MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14406909 ↗
• MalfunctionMar 21, 2022Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT ONE OF THE FOLEY CATHETER WAS CLOGGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13840425 ↗
• MalfunctionJul 30, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE FOLEY CATHETERS LEAKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12252745 ↗
• MalfunctionMay 10, 2021Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE FOLEY CATHETERS WERE SENT OUT DUE TO THE BALLOON WAS UNABLE TO INFLATE. THE CUSTOMER HAD TO CHANGE THE CATHETERS AND TRIED SEVERAL OF THEM. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11801983 ↗
• MalfunctionApr 7, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON BURST WAS NOTED INSIDE THE PATIENT WHICH CAUSED THE PATIENT TO GO TO THE HOSPITAL.

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

  MAUDE report 11629066 ↗
• MalfunctionApr 7, 2021Decrease in Pressure; Material Split, Cut or Torn; Decrease in Pressure; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PATIENT HAD A DEFECTIVE PRODUCT BUT UNSURE WHETHER IT WAS THE DRAIN BAG OR THE FOLEY CATHETER. IT WAS STATED THAT THE FOLEY CATHETER WAS PULLED BUT THE BALLOON DEFLATED AND LEAKED OUTSIDE THE DRAIN BAG. IT WAS NOTED THAT NOTHING WAS GOING INTO THE DRAIN BAG. THE CATHETER HAD TO BE CHANGED SOONER THAN EXPECTED. PER FOLLOW UP VIA PHONE 15APR2021, CUSTOMER STATED THAT THE CATHETER RIPPED AT THE Y CONNECTOR WHICH CAUSED THE BALLOON TO DEFLATE AND THE PATIENT TO EXPERIENCE URINE LEAKAGE. THE EVENT OCCURRED ON THE SAME DAY OF USE. THE CATHETER WAS REPLACED BUT THEN URINE WOULD NOT DRAIN INTO THE BAG. THE CUSTOMER NOTED THAT THERE MAY HAVE BEEN A PIECE OF PLASTIC BETWEEN THE TUBE AND THE ANTI-REFLUX CHAMBER ON THE BAG WHICH WAS PREVENTING DRAINAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11628854 ↗
• MalfunctionApr 4, 2021Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE PATIENT HAD A DEFECTIVE PRODUCT BUT NOT SURE IF IT WAS THE DRAIN BAG OR THE FOLEY CATHETER. STATED THAT THE FOLEY CATHETER WAS PULLED BUT THE BALLOON DEFLATED AND LEAKED OUTSIDE THE DRAIN BAGS AND NOTHING WAS GOING INTO THE DRAIN BAG. THE CATHETER HAD TO BE CHANGED SOONER THAN EXPECTED. PER FOLLOW UP VIA PHONE 15APR2021, CUSTOMER STATED THAT THE CATHETER RIPPED AT THE Y CONNECTOR WHICH CAUSED THE BALLOON TO DEFLATE AND THE PATIENT TO EXPERIENCE URINE LEAKAGE. THE EVENT OCCURRED ON THE SAME DAY OF USE. THE CATHETER WAS REPLACED BUT THEN URINE WOULD NOT DRAIN INTO THE BAG. THE CUSTOMER NOTED THAT THERE MAY HAVE BEEN A PIECE OF PLASTIC BETWEEN THE TUBE AND THE ANTI-REFLUX CHAMBER ON THE BAG WHICH WAS PREVENTING DRAINAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11611990 ↗
• MalfunctionMar 9, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE BALLOON POPPED AND THE CATHETER CAME OFF FROM THE PATIENT AT NIGHT WHILE SLEEPING. THE PATIENT HAD TO GO TO THE EMERGENCY ROOM AND THE CATHETER HAD TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11449489 ↗
• MalfunctionJan 20, 2021Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE PATIENT STATED CATHETERS WERE GETTING CLOGGED AND HAD TO BE CHANGED EVERY 8-9 DAYS RATHER THAN EVERY 2 WEEKS, AS MENTIONED IN THE PRESCRIPTION. REPRESENTATIVE ADVISED PATIENT TO SPEAK WITH DOCTOR REGARDING THE ISSUES.

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

  MAUDE report 11203501 ↗
• MalfunctionMay 20, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PATIENT HAD BLEEDING AND SOME LEAKING WITH FOLEY 2 WAY 22FR CATHETER. AFTER HOME HEALTH AGENCY CHANGED THE CATHETER TO 24FR, THERE WAS NO PROBLEM WITH THE PATIENT.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 10075668 ↗
• MalfunctionApr 28, 2020Burst Container or Vessel

  IT WAS REPORTED THAT THE BALLOON ON THE FOLEY CATHETER BURST.

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

  MAUDE report 10006232 ↗
• MalfunctionFeb 18, 2020Deflation Problem; Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE BALLOON ON THE FOLEY CATHETER WOULD NOT PASSIVELY DEFLATE WITH THE SYRINGE. THE COMPLAINANT REPORTED THAT THE USER THEN TRIED TO PULL BACK ON THE SYRINGE BUT THAT WOULD NOT WORK EITHER. THE CATHETER WAS ULTIMATELY CUT AND THE BALLOON GOT DEFLATED.

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

  MAUDE report 9721021 ↗
• MalfunctionDec 3, 2019Burst Container or Vessel

  IT WAS REPORTED THAT THE BALLOON BURST INSIDE OF THE PATIENT, AND IT WAS RETRIEVED IN ONE PIECE BY THE PATIENT. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 9403923 ↗
• InjuryAug 13, 2019Material Invagination; Material Invagination

  IT WAS REPORTED THE FOLEY CATHETER BALLOONED OUT OF HER BODY, CAUSING TISSUE DAMAGE AROUND HER STOMA THAT HAD TO BE OPERATED ON (B)(6) 2019.

  Patient problems: Tissue Damage

  MAUDE report 8887865 ↗
• MalfunctionMar 25, 2019Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THERE WAS A PINHOLE IN THE BALLOON OF THE FOLEY CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8449777 ↗
• MalfunctionOct 23, 2018Leak/Splash; Fluid/Blood Leak; Leak/Splash

  IT WAS REPORTED THAT THE FOLEY CATHETER LEAKED AT THE BOTTOM OF THE BALLOON DURING PRETEST.

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

  MAUDE report 7995866 ↗
• MalfunctionSep 25, 2018Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON WOULD NOT FULLY DEFLATE. THE PATIENT WAS ABLE TO REMOVE THE FOLEY, BUT UPON REMOVAL NOTED THAT IT APPEARED CALCIFIED. THE PATIENT ALLEGEDLY EXPERIENCED BLEEDING AFTER REMOVAL OF THE CATHETER. NO MEDICAL INTERVENTION REPORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7905604 ↗
• MalfunctionDec 6, 2017Leak/Splash

  IT WAS REPORTED THAT THE CATHETER LEAKED FROM AN UNKNOWN LOCATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7087985 ↗
• MalfunctionJul 12, 2017Component Falling; Material Rupture

  IT WAS REPORTED THAT, AFTER AN UNUSUAL SOUND, THE FOLEY FELL OUT AND THE BALLOON RUPTURE WAS FOUND. THE PATIENT STATED THAT THE FOLEY WAS IMPLEMENTED ON (B)(6). IT WAS CONFIRMED THAT NO PIECES WERE LEFT INSIDE THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6709427 ↗