Bardex Pediatric All-Silicone Foley CatheterRecalls & reported problems across all models

We found 2 models of Bardex Pediatric All-Silicone Foley Catheter by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 115 adverse event reports in the FDA's MAUDE database, received between May 17, 2017 and Aug 26, 2026 — classified as 12 injuries, 103 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (16 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Bardex Pediatric All-Silicone Foley Catheter problems

Bardex Pediatric All-Silicone Foley Catheter models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Bardex® Pediatric All-Silicone Foley Catheter 165808

  CATHETER, UROLOGICAL
  72 reports
• Bardex® Pediatric All-Silicone Foley Catheter 165810

  CATHETER, UROLOGICAL
  43 reports

Recent Bardex Pediatric All-Silicone Foley Catheter adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionJul 27, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50028208 ↗
• 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 ↗
• MalfunctionJul 30, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THERE HAD BEEN MULTIPLE INSERTION ISSUES WITH FOLEY CATHETER. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 18JUL2025, IT WAS REPORTED THAT THE FOLEY CATHETER INSERTED AND INFLATED WITH 5ML STERILE WATER OF THE BALLOON PER MANUFACTURER INSTRUCTION. THE FOLEY CATHETER REMOVED PER SURGICAL TEAM. FOLEY CATHETER BALLOON DEFLATED AND REMOVED 5ML OF STERILE WATER. THERE AS A RESISTANCE WHEN TRYING TO REMOVED THE CATHETER. INFORMED TO DOCTOR AND THEY TRIED TO REMOVE HERSELF AND REMOVED SUCCESSFULLY. ASSESSED THE URETERAL ORIFICE, REDNESS AND NO BLEEDING NOTED. THE FOLEY CATHETER TIP WITH HE BALLOON FORMED A RING AROUND THE CATHETER .THE CUSTOMER BROUGHT A DEFECTIVE BARD FOLEY SILICONE CATHETER 10 FR.BARDEX165810. THE CATHETER BALLOON DOES NOT FULLY DEFLATE AND FORMS A RING INSTEAD OF COLLAPSING AGAINST THE SHEATH. IT WAS REPORTED THAT MULTIPLE NURSES HAD EXPERIENCED THIS WITH THEIR PATIENTS BUT HAD NOT REPORTED IT. THEY CANNOT DETERMINE IF OTHER SIZES OF THE CATHETERS ARE ALSO DEFECTIVE. THE LOTS WERE IDENTIFIED LOT#NGJW3356, NGGZ1490, NGGHW2036, NGJU2172. PER ADDITIONAL INFORMATION RECEIVED VIA PHONE ON 25JUL2025, IT WAS REPORTED THAT TYPE OF CATHETER FAILURE (B)(

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

  MAUDE report 22666894 ↗

Other C. R. Bard, Inc. products

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