Bardex® Pediatric All-Silicone Foley Catheter 165810Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00801741029721), received between May 19, 2017 and Jul 27, 2026 — classified as 2 injuries, 41 malfunctions.

The most frequently reported specific device problem is “Material Invagination” (9 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 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50028208 ↗
• 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 ↗
• MalfunctionApr 30, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT FOLEY CATHETER WAS CLOGGED. NOTHING GONE THROUGH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21935038 ↗
• MalfunctionOct 8, 2024Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT DURING THE SURGERY, URINE DID NOT FLOW FROM THE FOLEY CATHETER. THE DRAINAGE LUMEN MAY BE BLOCKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20396831 ↗
• MalfunctionSep 26, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE CUSTOMER WERE HAVING SOME ISSUES WITH THE 2-WAY FOLEY CATHETERS AND THE BALLOON POPPING BEFORE THE RECOMMENDED FLUID WAS PLACED INTO THE CATHETER. IT WAS HAPPENING IN THEIR 12 FR SIZE (PCN# 165812 - LOT# NGJS0552) AND 10 FR SIZES (PR# 165810 - LOT# UNK), IN MULTIPLE LOT NUMBERS (PCN# 165812 - LOT# UNK) . THESE EVENTS HAD BEEN ON GOING SO WOULD WANT TO MAKE SURE THERE WAS NO EDUCATIONAL GAP THAT NEEDED TO BE CLOSED ON THEIR END. STAFF EXPERIENCED MEETING RESISTANCE AND THE BALLOON POPPING BEFORE THE FULL AMOUNT OF RECOMMENDED FLUID WAS PLACED INTO THE CATHETER (10 ML FOR 5 CC BALLOON AND 5 ML FOR 3 CC BALLOON). NO KNOWN INJURIES WERE REPORTED. STAFF MET RESISTANCE AND DIFFICULTY IN INFLATING THE CATHETER AFTER INSERTING 5 ML OF STERILE WATER. NO SAMPLES ARE AVAILABLE CURRENTLY, IT WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20310069 ↗
• MalfunctionJun 20, 2024Dent in Material; Dent in Material

  IT WAS REPORTED THAT REGISTERED NURSE WENT TO REMOVE FOLEY RESISTANCE WAS MET, THIS REGISTERED NURSE STOPPED IMMEDIATELY. UROLOGY CONSULTED AND EN ROUTE. WHEN REGISTERED NURSE WENT TO GO EXAMINE FOLEY CATHETER AFTER REMOVED IT LOOKED LIKE THE BALLOON WAS ONLY INFLATING ON ONE SIDE (PCN# (B)(4) ). PER FOLLOW UP VIA EMAIL ON 20MAR2024, THE PATIENT EXPERIENCED TEMPORARY PAIN, BUT NO PHYSICAL HARM. PER SAMPLE RECEIVED ON 15APR2024, IT WAS NOTED THAT THE FOLEY CATHETER WAS RETURNED FOR EVALUATION (PCN# (B)(4) ). PER NOTIFICATION FROM INVESTIGATOR ON 10MAY2024, DURING SAMPLE EVALUATION IT WAS FOUND THAT THE FOLEY CATHETER BALLOON WAS MUSHROOMED (PCN# (B)(4) ). PER FOLLOW UP RESPONSE VIA EMAIL ON 28MAY2024, CUSTOMER CALLED TO REPORT THAT THERE WAS MINOR IMPACT TO THE PATIENT. THE PATIENT HAD PAIN BUT DID NOT SEEK MEDICAL ATTENTION. (PCN# (B)(4) ).

  Patient problems: Pain

  MAUDE report 19577906 ↗
• MalfunctionApr 24, 2024Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE URINE DID NOT DRAIN FROM THE FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19169876 ↗
• MalfunctionJan 23, 2024Material Invagination; Difficult to Remove; Material Invagination; Difficult to Remove

  IT WAS REPORTED THAT WHEN REMOVED THE FOLEY CATHETER, THERE WAS A BULGE IN THE CUFF (IRREGULARITIES IN THE SILICONE), MADE IT DIFFICULT TO REMOVE. NO ABNORMALITIES WERE DETECTED THROUGHOUT THE CATHETER. THEY DISCARDED A SYRINGE MADE BY ANOTHER COMPANY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18562941 ↗
• MalfunctionDec 19, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE STERILE WATER LEAKED FROM THE INFLATION VALVE OF THE FOLEY CATHETER DURING STERILE WATER INJECTION. NO ABNORMALITY WAS FOUND IN THE VALVE. NO ABNORMALITIES WERE DETECTED THROUGHOUT THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18355631 ↗
• MalfunctionNov 8, 2023Incorrect Measurement; Nonstandard Device; Incorrect Measurement; Nonstandard Device

  IT WAS REPORTED THAT THE FOLEY CATHETERS WERE FLIMSY AND BENDING WITH RESISTANCE (PCN#165808 AND PCN#165810). ADDITIONALLY, THE BALLOON SEEMED TO BE LARGER (PCN#165808 AND PCN#165810) AND WAS NOT DEFLATING ALL THE WAY RESULTING IN TEARS AND BLEEDING (PCN#165808 AND PCN#165810).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18092024 ↗
• InjuryNov 6, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE FOLEY CATHETERS WERE FLIMSY AND BENDING WITH RESISTANCE (PCN#165808 AND PCN#165810). ADDITIONALLY, THE BALLOON SEEMED TO BE LARGER (PCN#165808 AND PCN#165810) AND WAS NOT DEFLATING ALL THE WAY RESULTING IN TEARS AND BLEEDING (PCN#165808 AND PCN#165810). MEDICAL INTERVENTION WAS UNKNOWN.

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

  MAUDE report 18072567 ↗
• MalfunctionFeb 13, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON WAS FOUND TO BE BURST UPON INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16363584 ↗
• MalfunctionSep 21, 2022Material Invagination; Material Invagination

  IT WAS REPORTED THAT PEDIATRIC SURGEONS HAVE HAD ISSUES WITH THESE FOLEY CATHETERS NOT DEFLATING CORRECTLY AT THE END OF CASES, MAKING THEM DIFFICULT TO REMOVE AND POTENTIALLY INJURING PATIENTS. ALSO STATED THAT IT LOOKED LIKE THE BALLOON WAS INVERTING ON ITSELF, BUT IT WAS NOT COMPLETELY DEFLATING. TWO SPECIFIC CATHETER HAD AN ISSUES (165810-BATCH # NGGN0481, 165814-BATCH # NGGQ4886). NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 15461459 ↗
• MalfunctionJul 1, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT IT WAS DIFFICULT TO DEFLATE THE FOLEY CATHETER DURING PRETEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14886247 ↗
• MalfunctionApr 6, 2022Inadequacy of Device Shape and/or Size; Material Too Soft/Flexible; Inadequacy of Device Shape and/or Size; Material Too Soft/Flexible

  IT WAS REPORTED THAT THE FOLEY CATHETERS WERE LEAKING AND DISLODGING EVERY TIME THEY INSERTED INTO THE PATIENT. THIS WAS A TRANSGENDER PATIENT CONVERTING FROM A FEMALE TO A MALE. STATED THAT THEY NEED A STIFFER OR FIRMER FOLEY FOR THIS PATIENT BECAUSE THEY NEED TO KEEP THE URETHRA OPEN FOR AN EXTENDED PERIOD OF TIME BECAUSE THERE WERE MULTIPLE RECONSTRUCTION SURGERIES WITH THIS TRANSITION. PER PHOTO SAMPLE, IT WAS FOUND THAT THE FOLEY CATHETER BALLOONS WERE ASYMMETRICAL. THE AFFECTED PRODUCT CATALOG NUMBERS WERE 165810 AND 165812.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14029570 ↗
• MalfunctionApr 6, 2022Dent in Material; Dent in Material

  IT WAS REPORTED THAT THE SILICONE FOLEY CATHETERS WERE LEAKING AND DISLODGING EVERY TIME THEY INSERTED INTO THE PATIENT. THIS WAS A TRANSGENDER PATIENT CONVERTING FROM A FEMALE TO A MALE. SO, THEY NEEDED A STIFFER OR FIRMER FOLEY FOR THIS PATIENT BECAUSE THEY NEED TO KEEP THE URETHRA OPEN FOR AN EXTENDED PERIOD OF TIME BECAUSE THERE WERE MULTIPLE RECONSTRUCTION SURGERIES WITH THIS TRANSITION. PER PHOTO SAMPLE PROVIDED, IT WAS FOUND THAT THE FOLEY CATHETER BALLOONS WERE LOPSIDED WHICH WAS LEADING TO THE ISSUES THAT CUSTOMER WAS EXPRESSING. THE AFFECTED PRODUCT CATALOG NUMBERS WERE 165810 WITH BATCH NO. NGFT5821, 165812 WITH BATCH NO. NGEZ0706 AND 165812 WITH BATCH NO. NGFW3722.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14021939 ↗
• MalfunctionMar 24, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE USER EXPERIENCED PAIN, HEMATURIA AND LEAKAGE WHILE USING THE FOLEY CATHETER WHEN THEY WERE ASKED FOR THE COMPLICATIONS WHILE USING THE FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13892392 ↗
• MalfunctionFeb 18, 2022Material Invagination; Difficult to Remove; Material Invagination; Difficult to Remove

  IT WAS REPORTED THAT THE SILICONE FOLEY CATHETER BALLOON DID NOT DEFLATE PROPERLY AND A CUFF RING COULD BE OBSERVED WHERE THE BALLOON WAS DEFLATED. USER STATED THAT THE PATIENTS URETHRAL OPENING WAS REDDENED AFTER GENTLY MANIPULATING THE CATHETER AND REMOVING IT FROM THE PATIENT¿S BODY. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Skin Discoloration

  MAUDE report 13561469 ↗
• MalfunctionDec 5, 2021Material Invagination; Material Invagination

  IT WAS REPORTED THAT THE NURSE ATTEMPTED TO REMOVE FOLEY CATHETER BY WITHDRAWING 5ML OF SALINE WATER AND TRIED TO PULL THE FOLEY CATHETER OUT OF THE PATIENT. NURSE STATED THAT THEY WERE ABLE TO REMOVE THE CATHETER UNTIL THE TIP OF PATIENT PENIS AND THEN IT GOT STUCK. THE NURSE AND DOCTOR CAME INTO THE ROOM AND ATTEMPTED TO REMOVE, NURSE PULLED GENTLY AND THE FOLEY CATHETER WAS STUCK AND WAS PAINFUL FOR THE PATIENT. DOCTOR WAS ABLE TO TWIST THE CATHETER SLOWLY AND THE FOLEY CATHETER CAME OUT. NURSE STATED THAT ON REMOVAL OF THE FOLEY CATHETER IT WAS FOUND THAT THE BALLOON WAS FULLY DEFLATED AND HAD A SLIGHT RIDGE IN IT.

  Patient problems: Pain

  MAUDE report 12931176 ↗
• MalfunctionDec 5, 2021Material Invagination; Material Invagination

  IT WAS REPORTED THAT THE PRIMARY NURSE ATTEMPTED TO REMOVE THE PATIENT¿S FOLEY CATHETER AND WITHDREW 5ML OF SALINE AND PULLED ON THE FOLEY CATHETER. THE USER WAS ABLE TO REMOVE UNTIL THE TIP OF PATIENT'S PENIS WHERE IT BECAME STUCK. THE WRITER PULLED IT GENTLY AND REPORTED THAT THE FOLEY WAS STUCK AND PAINFUL FOR THE PATIENT. LATER, THE DOCTOR WAS ABLE TO TWIST SLOWLY AND THE FOLEY CAME OUT. IT WAS THEN OBSERVED THAT A SLIGHT RIDGE WAS ON THE FULLY DEFLATED BALLOON OF THE FOLEY.

  Patient problems: Pain

  MAUDE report 12931157 ↗
• MalfunctionOct 5, 2021Material Invagination; Material Invagination

  IT WAS REPORTED THAT THE 10 FR ALL-SILICONE FOLEY CATHETER BALLOON WAS STUCK UPON REMOVAL AFTER 5 DAYS FROM PLACEMENT. IT WAS STATED THAT THE BALLOON WAS CUFFED, WHICH LEADS TO DIFFICULTY IN REMOVING THE CATHETER. THE UROLOGIST WHO PLACED THE CATHETER HAD NO ISSUES WITH THE PLACEMENT, EVEN THOUGH OTHERS FAILED, AND INSTILLED 5 ML OF WATER AS RECOMMENDED. PER ADDITIONAL INFORMATION RECEIVED VIA SAMPLE FORM ON 19JAN2022, IT WAS STATED THAT THE PATIENT EXPERIENCED PAIN WHEN THE FOLEY CATHETER WAS REMOVED AND STATED THAT SIGNIFICANT MANIPULATION AND ADDITIONAL LUBRICATION WAS REQUIRED TO REMOVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 12579606 ↗
• MalfunctionJan 20, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE PATIENT ARRIVED TO UNIT FROM POST ANESTHESIA CARE UNIT WITH A 10F FOLEY CATHETER. IT WAS NOTED BY THE TECH THAT SOMEHOW THE BALLOON HAD BROKEN, AND IT HAD SLIPPED OUT OF THE PATIENT'S URETHRA.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Code Available

  MAUDE report 11202474 ↗
• MalfunctionDec 29, 2020Material Invagination; Material Invagination

  IT WAS REPORTED THAT THE BALLOON HAD A PROTRUDING RIDGE AROUND THE TIP OF THE CATHETER AFTER THE BALLOON WAS DEFLATED DURING THE PRETEST PRIOR TO INSERTION. FURTHER INSPECTION NOTED THAT THE PACKAGE IDENTIFIES THE BALLOON WAS BEING 3CC YET THE PRODUCT ITSELF WAS LISTED AS A 5ML BALLOON. THE PATIENT WAS BEING PREPPED FOR SURGERY WHEN THE INCIDENT WAS OCCURRED. PER A FOLLOW UP RESPONSE RECEIVED VIA EMAIL ON (B)(6) 2020 IT WAS STATED THAT THE USER REPORTED ANOTHER OCCURRENCE OF A PEDIATRIC CATHETER BALLOON AFTER DEFLATION WITH A NOTICEABLE RIDGE WAS PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11089986 ↗
• MalfunctionOct 22, 2020Material Invagination; Material Invagination

  IT WAS REPORTED THAT THE CATHETERS WITH 3CC BALLOONS SHOULD BE INFLATED WITH 5CC PER THE INSTRUCTIONS AND THE CATHETERS WITH 5CC BALLOONS SHOULD BE INFLATED WITH 10CC . IN ADDITION, THE FOLEY CATHETER BALLOON DOES NOT FULLY DEFLATE WHICH COULD CAUSE HARM TO OUR PATIENTS ON CATHETER, AFTER DEFLATING THE BALLOON, A FIRM RIDGE IS LEFT AROUND THE TIP OF THE CATHETER WHICH COULD CAUSE INJURY ON REMOVAL. AS PER THE FOLLOW UP VIA EMAIL ON 29SEP2020, THE COMPLAINANT STATED THAT THEY INFLATE THE CATHETERS WITH WHATEVER ML IS WRITTEN ON THE ACTUAL CATHETER PORT AS THERE ARE DIFFERENT VOLUMES BASED ON THE CATHETER SIZE AND THE BALLOONS WERE DEFLATED WITH A SYRINGE.

  Patient problems: Injury

  MAUDE report 10717775 ↗
• MalfunctionOct 22, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE CATHETERS WITH 3CC BALLOONS SHOULD BE INFLATED WITH 5CC PER THE INSTRUCTIONS AND THE CATHETERS WITH 5CC BALLOONS SHOULD BE INFLATED WITH 10CC . IN ADDITION, THE FOLEY CATHETER BALLOON DOES NOT FULLY DEFLATE WHICH COULD CAUSE HARM TO OUR PATIENTS ON CATHETER, AFTER DEFLATING THE BALLOON, A FIRM RIDGE IS LEFT AROUND THE TIP OF THE CATHETER WHICH COULD CAUSE INJURY ON REMOVAL . AS PER THE FOLLOW UP VIA EMAIL ON 29SEP2020, THE COMPLAINANT STATED THAT THEY INFLATE THE CATHETERS WITH WHATEVER ML IS WRITTEN ON THE ACTUAL CATHETER PORT AS THERE ARE DIFFERENT VOLUMES BASED ON THE CATHETER SIZE AND THE BALLOONS WERE DEFLATED WITH A SYRINGE.

  Patient problems: Injury

  MAUDE report 10717687 ↗