Bardex® Pediatric All-Silicone Foley Catheter 165808Recalls & reported problems

Summary

The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 00801741029714), received between May 17, 2017 and Aug 26, 2026 — classified as 10 injuries, 62 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 72 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2026Inflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50456176 ↗
• InjuryMay 29, 2026Difficult to Remove

  IT WAS REPORTED THAT THE FOLEY CATHETER INSERTED IN CERVIX AND INSERTED IN UTERUS FOR CASE FOR CHROMOTUBATION. AT END OF CASE FOLEY WAS ATTEMPTED TO BE REMOVED. WHEN BALLOON WAS ATTEMPTED TO BE DEFLATED, IT WOULD NOT DEFLATE. TWO DIFFERENT SYRINGES WERE TRIED WITH NO SUCCESS. END PORT WHERE SYRINGE GETS ATTACHED WAS CUT BY SURGEON TO ATTEMPT TO MANUALLY DEFLATE THE BALLOON, AND THE BALLOON STILL DID NOT DEFLATE. HYSTEROSCOPY WAS USED TO DEFLATE BALLOON TO REMOVE FROM UTERUS/CERVIX. THIS WAS THE SECOND CASE OF THE DAY WITH THE SAME REF: 165808 FOR THIS PRODUCT WHERE THE BALLOON WOULD NOT DEFLATE. IN BOTH CASES, THE PATIENT UNDERWENT HYSTEROSCOPY AND USED A NEEDLE TO POP THE BALLOON IN ORDER TO REMOVE THE FOLEY. THERE WERE 2 DIFFERENT LOT NUMBERS: NGKX1801 & NGKR2525. THE SURGEON HAS BEEN PERFORMING THIS PROCEDURE FOR 19 YEARS AND IS VERY EXPERIENCED USING THE PRODUCT AND HAS ONLY RECENTLY HAD THIS ISSUE.

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

  MAUDE report 25340587 ↗
• MalfunctionFeb 5, 2026Difficult to Remove

  IT WAS REPORTED THAT AT THE END OF THE CASE, A FOLEY CATHETER WAS PLACED. DURING BALLOON INFLATION, RESISTANCE WAS NOTED AT ABOUT 2ML, SO INFLATION WAS STOPPED. THE BALLOON WOULD NOT DEFLATE WITH ASPIRATION, SO THE INFLATION PORT WAS CUT, ALLOWING THE BALLOON TO DEFLATE. THE FOLEY WAS THEN REMOVED EASILY WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24268766 ↗
• MalfunctionFeb 5, 2026Inflation Problem

  IT WAS REPORTED THAT AT THE END OF THE CASE, A FOLEY CATHETER WAS PLACED. DURING BALLOON INFLATION, RESISTANCE WAS NOTED AT ABOUT 2ML, SO INFLATION WAS STOPPED. THE BALLOON WOULD NOT DEFLATE WITH ASPIRATION, SO THE INFLATION PORT WAS CUT, ALLOWING THE BALLOON TO DEFLATE. THE FOLEY WAS THEN REMOVED EASILY WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24268763 ↗
• InjuryJan 26, 2026Difficult to Remove

  IT WAS REPORTED THAT THE BALLOON ON THE FOLEY CATHETER WOULD NOT DEFLATE ON TWO DIFFERENT OCCASIONS. THE FIRST TIME THE DOCTOR WAS ABLE TO DEFLATE THAT USING MINERAL OIL TO DISSOLVE THAT (LOT- NGKV0323) AND THEN THE SECOND TIME THE DOCTOR OFFICE WAS CLOSED DUE TO THE HOLIDAYS WHICH CAUSED THEM TO HAVE TO GO TO THE EMERGENCY ROOM. THIS WAS A PEDIATRIC PATIENT.

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

  MAUDE report 24185878 ↗
• MalfunctionJan 26, 2026Material Puncture/Hole

  IT WAS REPORTED THAT THEY FOUND SLOW LEAK ABOVE Y-SITE OF THE FOLEY CATHETER, PROBABLE HOLE OR RIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24185528 ↗
• MalfunctionJan 23, 2026Difficult to Remove

  IT WAS REPORTED THAT THE BALLOON ON THE FOLEY CATHETER WOULD NOT DEFLATE ON TWO DIFFERENT OCCASIONS. THE FIRST TIME THE DOCTOR WAS ABLE TO DEFLATE THAT USING MINERAL OIL TO DISSOLVE THAT (LOT- NGKV0323) AND THEN THE SECOND TIME THE DOCTOR OFFICE WAS CLOSED DUE TO THE HOLIDAYS WHICH CAUSED THEM TO HAD TO GO TO THE EMERGENCY ROOM. THIS WAS A PEDIATRIC PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24171740 ↗
• MalfunctionJan 2, 2026Material Puncture/Hole

  IT WAS REPORTED THAT WHEN THE FOLEY WAS INSERTED THE CATHETER WAS DEFECTIVE AND PUNCTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23951633 ↗
• MalfunctionOct 1, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT CUSTOMER SEEING BLACK SPECKS/DEBRIS ON WHAT SHOULD BE A STERILE BARDEX ALL-SILICONE FOLEY CATHETER. AT LEAST 4 TIMES NOW CUSTOMER HAVE FOUND DEBRIS CLOSE TO THE TIP OF THE FOLEY CATHETER. IT IS USUALLY A SMALL BLACK SPECK THAT SEEMS TO BE ATTACHED CLOSE TO THE TIP OF THE CATHETER WHICH CUSTOMER HAVE TO FORCEFULLY REMOVE USING A LUBRICANT AND STERILE GLOVES! CUSTOMER HAS BEEN USING THIS SAME PRODUCT FOR AT LEAST 4 YEARS NOW AND FOR THE LAST 2-3 MONTHS THIS STARTED HAPPENING. THIS IS TOTALLY UNACCEPTABLE FOR A PRODUCT THAT IS SUPPOSED TO BE STERILE. CUSTOMER EVEN HAD TO THROW ONE AWAY SINCE IT HAD TOO MUCH DEBRIS/DUST WHATEVER IT IS THAT IS STUCK TO IT. CUSTOMER ALSO EXPERIENCED AT LEAST 3 TIMES WHERE LEAKING TAKES PLACE DUE TO A VERY SMALL HOLE OR CUT AROUND THE CORNER OF THE FOLEY, WHERE THE TUBE TURNS FROM ONE TUBE TO TWO TUBES. THIS HAS CAUSED SO MUCH TROUBLE DUE TO CLOTHING AND BEDDING GETTING SOAKED OVERNIGHT FROM THE SMALL CONSTANT DRIPPINGS. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 29SEP2025, CUSTOMER HAS SO MANY CATHETERS THAT ARE UNUSABLE SINCE THEY HAVE SMALL DEBRIS ON THEM. A FEW THAT CUSTOMER HAS OPENED THE OUTER PACKAGING BUT NOT THE INNER P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23190800 ↗
• MalfunctionOct 1, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT CUSTOMER SEEING BLACK SPECKS/DEBRIS ON WHAT SHOULD BE A STERILE BARDEX ALL-SILICONE FOLEY CATHETER. AT LEAST 4 TIMES NOW CUSTOMER HAVE FOUND DEBRIS CLOSE TO THE TIP OF THE FOLEY CATHETER. IT IS USUALLY A SMALL BLACK SPECK THAT SEEMS TO BE ATTACHED CLOSE TO THE TIP OF THE CATHETER WHICH CUSTOMER HAVE TO FORCEFULLY REMOVE USING A LUBRICANT AND STERILE GLOVES! CUSTOMER HAS BEEN USING THIS SAME PRODUCT FOR AT LEAST 4 YEARS NOW AND FOR THE LAST 2-3 MONTHS THIS STARTED HAPPENING. THIS IS TOTALLY UNACCEPTABLE FOR A PRODUCT THAT IS SUPPOSED TO BE STERILE. CUSTOMER EVEN HAD TO THROW ONE AWAY SINCE IT HAD TOO MUCH DEBRIS/DUST WHATEVER IT IS THAT IS STUCK TO IT. CUSTOMER ALSO EXPERIENCED AT LEAST 3 TIMES WHERE LEAKING TAKES PLACE DUE TO A VERY SMALL HOLE OR CUT AROUND THE CORNER OF THE FOLEY, WHERE THE TUBE TURNS FROM ONE TUBE TO TWO TUBES. THIS HAS CAUSED SO MUCH TROUBLE DUE TO CLOTHING AND BEDDING GETTING SOAKED OVERNIGHT FROM THE SMALL CONSTANT DRIPPINGS. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 29SEP2025, CUSTOMER HAS SO MANY CATHETERS THAT ARE UNUSABLE SINCE THEY HAVE SMALL DEBRIS ON THEM. A FEW THAT CUSTOMER HAS OPENED THE OUTER PACKAGING BUT NOT THE INNER P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23190728 ↗
• MalfunctionSep 22, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT WHEN REMOVING THE FOLEY CATHETER, CUSTOMER FELT RESISTANCE AND UPON PULLING IT OUT, BLEEDING OCCURRED. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 23109421 ↗
• MalfunctionSep 17, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT CUSTOMER SEEING BLACK SPECKS/DEBRIS ON WHAT SHOULD BE A STERILE BARDEX ALL-SILICONE FOLEY CATHETER. AT LEAST 4 TIMES NOW CUSTOMER HAVE FOUND DEBRIS CLOSE TO THE TIP OF THE FOLEY CATHETER. IT IS USUALLY A SMALL BLACK SPECK THAT SEEMS TO BE ATTACHED CLOSE TO THE TIP OF THE CATHETER WHICH CUSTOMER HAVE TO FORCEFULLY REMOVE USING A LUBRICANT AND STERILE GLOVES! CUSTOMER HAS BEEN USING THIS SAME PRODUCT FOR AT LEAST 4 YEARS NOW AND FOR THE LAST 2-3 MONTHS THIS STARTED HAPPENING. THIS IS TOTALLY UNACCEPTABLE FOR A PRODUCT THAT IS SUPPOSED TO BE STERILE. CUSTOMER EVEN HAD TO THROW ONE AWAY SINCE IT HAD TOO MUCH DEBRIS/DUST WHATEVER IT IS THAT IS STUCK TO IT. CUSTOMER ALSO EXPERIENCED AT LEAST 3 TIMES WHERE LEAKING TAKES PLACE DUE TO A VERY SMALL HOLE OR CUT AROUND THE CORNER OF THE FOLEY, WHERE THE TUBE TURNS FROM ONE TUBE TO TWO TUBES. THIS HAS CAUSED SO MUCH TROUBLE DUE TO CLOTHING AND BEDDING GETTING SOAKED OVERNIGHT FROM THE SMALL CONSTANT DRIPPINGS. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 29SEP2025, CUSTOMER HAS SO MANY CATHETERS THAT ARE UNUSABLE SINCE THEY HAVE SMALL DEBRIS ON THEM. A FEW THAT CUSTOMER HAS OPENED THE OUTER PACKAGING BUT NOT THE INNER P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23072871 ↗
• MalfunctionSep 15, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT CUSTOMER SEEING BLACK SPECKS/DEBRIS ON WHAT SHOULD BE A STERILE BARDEX ALL-SILICONE FOLEY CATHETER. AT LEAST 4 TIMES NOW CUSTOMER HAVE FOUND DEBRIS CLOSE TO THE TIP OF THE FOLEY CATHETER. IT IS USUALLY A SMALL BLACK SPECK THAT SEEMS TO BE ATTACHED CLOSE TO THE TIP OF THE CATHETER WHICH CUSTOMER HAVE TO FORCEFULLY REMOVE USING A LUBRICANT AND STERILE GLOVES! CUSTOMER HAS BEEN USING THIS SAME PRODUCT FOR AT LEAST 4 YEARS NOW AND FOR THE LAST 2-3 MONTHS THIS STARTED HAPPENING. THIS IS TOTALLY UNACCEPTABLE FOR A PRODUCT THAT IS SUPPOSED TO BE STERILE. CUSTOMER EVEN HAD TO THROW ONE AWAY SINCE IT HAD TOO MUCH DEBRIS/DUST WHATEVER IT IS THAT IS STUCK TO IT. CUSTOMER ALSO EXPERIENCED AT LEAST 3 TIMES WHERE LEAKING TAKES PLACE DUE TO A VERY SMALL HOLE OR CUT AROUND THE CORNER OF THE FOLEY, WHERE THE TUBE TURNS FROM ONE TUBE TO TWO TUBES. THIS HAS CAUSED SO MUCH TROUBLE DUE TO CLOTHING AND BEDDING GETTING SOAKED OVERNIGHT FROM THE SMALL CONSTANT DRIPPINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23057228 ↗
• MalfunctionMay 13, 2025Fitting Problem; Tear, Rip or Hole in Device Packaging; Fitting Problem; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE CONNECTION PORT IS NOT SEALED WHEN USED WITH AN IRRIGATION SYRINGE. IRRIGATION IS USED DURING HYSTEROSONOGRAPHY EXAMINATIONS, AND THE LACK OF SEALING MAKES EXAMINATIONS DIFFICULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22009535 ↗
• MalfunctionApr 23, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WAS A HOLE IN THE FOLEY CATHETER WHICH CAUSED IT TO LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21892326 ↗
• MalfunctionApr 11, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT 8FR FOLEY CATHETER INSERTED AND THOUGHT TO BE BYPASSING. WRITER ASSESSED FOLEY CATHETER AND NOTED A PIN HOLE LEAK TO THE BASE OF THE CATHETER WHERE THE OPENING WOULD CONNECT TO THE DRAIN BAG. DUE TO INFECTION RISK FOLEY THEN HAD TO BE REMOVED. CATHER WAS REMOVED BY COLLEGE AND PRODUCT PACKAGING WAS THROWN AWAY AFTER INSERTION. NO APPARENT HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21825981 ↗
• MalfunctionApr 1, 2025Material Invagination; Material Invagination

  IT WAS REPORTED THAT THE FOLEY CATHETER AFTER INFLATION FAILS TO RETRACT FULLY LEAVING A LIP. IT APPEARED WHEN DEFLATING THE BALLON PRIOR TO REMOVING, THE BALLON LEAVES A LIP. THIS MAKES REMOVING THE FOLEY CATHETER DIFFICULT, CAUSING TRAUMA AND BLEEDING. ACCORDING TO ONE OF THEIR NEW REGISTRARS, THIS HAS ALSO BEEN EXPERIENCED AT (B)(6) HOSPITAL. PICTURES ATTACHED, ONE SHOWS BALLOON PRIOR TO INFLATING, THE OTHER SHOW A DEFLATED BALLOON WITH A LIP. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR TRAUMA AND BLEEDING.

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

  MAUDE report 21738914 ↗
• MalfunctionMar 31, 2025Material Invagination; Material Invagination

  IT WAS REPORTED THAT THE FOLEY CATHETER AFTER INFLATION FAILS TO RETRACT FULLY LEAVING A LIP. IT APPEARED WHEN DEFLATING THE BALLON PRIOR TO REMOVING, THE BALLON LEAVES A LIP. THIS MAKES REMOVING THE FOLEY CATHETER DIFFICULT, CAUSING TRAUMA AND BLEEDING. ACCORDING TO ONE OF THEIR NEW REGISTRARS, THIS HAS ALSO BEEN EXPERIENCED AT THE ROYAL CHILDREN¿S HOSPITAL. PICTURES ATTACHED, ONE SHOWS BALLOON PRIOR TO INFLATING, THE OTHER SHOW A DEFLATED BALLOON WITH A LIP. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 21730529 ↗
• MalfunctionFeb 11, 2025Partial Blockage; Partial Blockage

  IT WAS REPORTED BY THE CRITICAL CARE NURSES THAT IN AN ONLINE SURVEY THE PATIENT EXPERIENCED ADVERSE EVENTS DIRECTLY CAUSED / ATTRIBUTABLE TO THE USAGE OF DEVICE ALL-SILICONE FOLEY CATHETER, 2-WAY, PEDIATRIC LENGTH, 3CC BALLOON, 8 FR AND RESULTED IN THE FOLLOWING COMPLICATIONS: URINE RETENTION, URETHRAL INJURY/ URETHRAL STRICTURES OR EROSION, URETHRA CUTANEOUS FISTULA, BLOCKAGE, BLADDER SPASMS, PROSTATITIS, IRRITATION. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21354450 ↗
• InjuryFeb 7, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED BY THE CRITICAL CARE NURSES THAT IN AN ONLINE SURVEY THE PATIENT EXPERIENCED ADVERSE EVENTS DIRECTLY CAUSED / ATTRIBUTABLE TO THE USAGE OF DEVICE ALL-SILICONE FOLEY CATHETER, 2-WAY, PEDIATRIC LENGTH, 3CC BALLOON, 8 FR AND RESULTED IN THE FOLLOWING COMPLICATIONS: URINE RETENTION, URETHRAL INJURY/ URETHRAL STRICTURES OR EROSION, URETHRA CUTANEOUS FISTULA, BLOCKAGE, BLADDER SPASMS, PROSTATITIS, IRRITATION. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Cramp(s) /Muscle Spasm(s); Erosion; Fistula; Inflammation; Skin Inflammation/ Irritation; Tissue Breakdown; Urinary Retention

  MAUDE report 21332860 ↗
• MalfunctionDec 20, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT 8 FR FOLEY CATHETER INSERTED BUT WITH BALLOON INFLATION INDICATING TO INFLATE AT 5 ML, WITH 4 ML FLUID BALLOON POPPED AND CAME OUT OF PATIENT AT 11:36. BALLOON DEFLATED WHILE IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20986665 ↗
• MalfunctionOct 24, 2024Material Invagination; Difficult to Remove; Material Invagination; Difficult to Remove

  IT WAS REPORTED THAT AN ISSUE THEY HAVE HAD REPORTEDLY HAPPEN WITH OUR BARDEX SILICONE FOLEY CATHETERS. THEY HAVE HAD REPORTED 3 CATHETERS BECAME DIFFICULT TO REMOVE REQUIRING MORE FORCE THAN USUAL TO REMOVE. THE LAST DEVICE THEY HAD WAS SIZE 8FR OF 165808 LOT: NGJN2960 ON 23/9/2024 WHEN REQUIRED MEDICAL STAFF TO HELP REMOVE WITH THE USE OF LIGNOCAINE LUBRICANT IMPREGNATED GEL TO REMOVE. THEY KEPT THE FAULTY DEVICE, WHICH AT TIMES APPEARED TO HAVE A BALLOON THAT WHEN DEFLATED DID NOT FLATTEN TO THE SHAPE OF THE CATHETER. THEY WERE UNFORTUNATELY UNABLE TO REPORT WHETHER THE OTHER DEVICES WERE THE SAME SIZE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20522517 ↗
• InjuryJun 26, 2024Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT BARDEX PEDIATRIC FOLEY CATHETER CONNECTION WITH LIGHTWEIGHT URINE BAG NOT TIGHT AND NOT SECURE. DISCONNECTED WHEN PATIENT WAS MOVING AROUND AT HOME. PER ADDITIONAL INFORMATION RECEIVED ON 07JUN2024, STATED THAT THE URINE LEAKED BECAUSE OF LOOSE CONNECTION TO ALL URINE BAGS IN THE MARKET. THE HOSPITAL WAS CHANGING OUT ALL OUR SILICONE CATHETERS. PATIENTS DEVELOPED CATHETER-ASSOCIATED URINARY TRACT INFECTION (CAUTI). IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR THE URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 19614029 ↗
• MalfunctionApr 30, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THEY HAD 5 TO 7 FOLEY CATHETERS WHICH HAD LEAK AND THEY FELT IT HAD A RIDGE ON THEM AND WERE UNCOMFORTABLE. THIS WAS OCCURRED OVER THE PAST 3 TO 6 MONTHS SO THEY DID NOT HAVE DOCUMENTED A LOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19212260 ↗
• MalfunctionApr 30, 2024Material Invagination; Material Invagination

  IT WAS REPORTED THAT THEY HAD 5 TO 7 FOLEY CATHETERS WHICH HAD LEAK AND THEY FELT IT HAD A RIDGE ON THEM AND WERE UNCOMFORTABLE. THIS WAS OCCURRED OVER THE PAST 3 TO 6 MONTHS SO THEY DID NOT HAVE DOCUMENTED A LOT.

  Patient problems: Discomfort

  MAUDE report 19212259 ↗