Bardex® All-Silicone Foley Catheter 166816Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00801741029806), received between Dec 29, 2017 and Apr 9, 2026 — classified as 8 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Material Invagination” (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.

• MalfunctionApr 9, 2026Material Puncture/Hole

  IT WAS REPORTED BY THE RESOURCE NURSE AND THE STAFF HAVE BEEN HAVING SOME TROUBLE WITH THE BARDEX ALL SILICONE FOLEY CATHETER SIZE 16 WITH 5CC BULB. THEY ARE JUST FALLING OUT OF PATIENTS ACCORDING TO THE PATIENT. PATIENT REQUIRED REPLACEMENT OF 4 INDWELLING CATHETERS AND EVENTUALLY, A LATEX CATHETER WAS PLACED. NO OTHER ISSUE OBSERVED WITH THE CATHETER. UPON TESTING CURRENT STOCK AS WELL AS OTHER SIZES AND BULB SIZES ONLY ONE SIDE OF THE CATHETER IS INFLATING WHICH IS LEAVING THE BULB LOPSIDED WHICH CAN THEN EASILY PULL OUT. THEY HAVE ATTACHED A PHOTO OF WHAT THE CATHETER LOOKED LIKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24837671 ↗
• MalfunctionApr 7, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE FOLEY CATHETER HAD A LEAK AT THE NEXT WHERE THE WATER GOES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24810859 ↗
• MalfunctionSep 10, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT FOLEY CATHETER POPPED IN PATIENT'S CERVIX WHEN FILLED TO 30CC. NEW CATHETER OUT OF SAME BOX FILLED WITH 40CC WITH NO ISSUE. PER CUSTOMER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 26NOV2025. IT WAS REPORTED THAT NO SAMPLE WAS AVAILABLE. LOT NGJY2292 WAS PROVIDED AS THE AFFECTED LOT. NO PATIENT HARM WAS REPORTED, ALTHOUGH SMALL AMOUNT OF BLEEDING WAS NORMAL WITH THE PROCEDURE. UNSURE IF BLEEDING WAS FROM THE PROCEDURE OR FOLEY BREAKAGE. REPORTER STATED THAT THEY DID A TEST BULB PRIOR TO INSERTION AND NO ISSUE NOTED.

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

  MAUDE report 23015287 ↗
• MalfunctionJul 7, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT THE CATHETER IS LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22422137 ↗
• InjuryApr 10, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS PLACED AT PREVIOUS LOCATION BYPASSING LARGE AMOUNTS OF URINE. BALLOON CHECKED AND WAS OVER-INFLATED TO 35ML. THEY TRIED REPOSITIONING AND STILL BYPASSING LARGE AMOUNTS, SO ATTEMPTED TO REMOVE CATHETER BUT LARGE, ROUND, HARD PART OF CATHETER NOTED AND UNABLE TO REMOVE THROUGH URETHRA WITHOUT TEARING THROUGH SKIN. ATTEMPTED SEVERAL TIMES AND LARGE PIECE OF PLASTIC NOTED AROUND CATHETER. MD CALLED, ASSESSED WITH ULTRASOUND, INSTILLED LIDOCAINE JELLY AND AFTER SEVERAL ATTEMPTS ABLE TO REMOVE CATHETER. LARGE, HARD CIRCULAR AREA AROUND CATHETER NOTED. PATIENT EXPERIENCED PAIN AND UNABLE TO REINSERT CATHETER.

  Patient problems: Pain

  MAUDE report 19080242 ↗
• MalfunctionSep 16, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE FOLEY CATHETER DID NOT DEFLATE ALL THE WAY AND CAUSES PAIN WHEN IT WAS REMOVED. THE REPRESENTATIVE ADVISED PATIENT TO MAKE SURE THAT IT WAS DEFLATED ALL THE WAY. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Pain

  MAUDE report 15438425 ↗
• InjurySep 14, 2022Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT THE FOLEY CATHETER HAD AN UNKNOWN ISSUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. AS PER FOLLOW-UP INFORMATION RECEIVED FROM CANADA TEAM ON 20APR2022, THE FOLEY CATHETER HAD A MATERIAL DEFORMATION PROBLEM AND MECHANICAL JAM PROBLEM. IT WAS ALSO STATED THAT THE PATIENT EXPERIENCED HEMORRHAGE/BLEEDING. IT WAS UNKNOWN IF THE DEVICE CONTRIBUTED TO THE HEMORRHAGE/BLEEDING AT THIS TIME AND MEDICAL INTERVENTION WAS UNKNOWN. NO OTHER INFORMATION WAS AVAILABLE. AS PER FOLLOW-UP INFORMATION RECEIVED ON 30AUG2022, FOLEY CATHETER WAS REMOVED AND GOT STUCK ON THE WAY OUT CAUSING URETHRAL TRAUMA AND BLEEDING WITH REMOVAL AND POST REMOVAL . UPON INSPECTION OF THE CATHETER POST REMOVAL, THERE WERE WRINKLES AND ROLLS IN THE AREA WHERE THE BALLOON WAS INFLATED, FRANK BLOOD NOTED ON THE AREA AND IN THE TIP OF THE CATHETER. THE PATIENT ALSO EXPERIENCED URETHRA TISSUE BREAKDOWN WHILE THE CATHETER WAS INSERTED, DESPITE THE SECUREMENT OF THE CATHETER TO THE PATIENT'S THIGH, POSSIBLY DUE TO THE RIGID NATURE OF THE PRODUCT . IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Tissue Breakdown

  MAUDE report 15418339 ↗
• InjurySep 14, 2022Material Invagination; Material Invagination

  IT WAS REPORTED THAT THE FOLEY CATHETER HAD AN UNKNOWN ISSUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. AS PER FOLLOW-UP INFORMATION RECEIVED FROM CANADA TEAM ON 20APR2022, THE FOLEY CATHETER HAD A MATERIAL DEFORMATION PROBLEM AND MECHANICAL JAM PROBLEM . IT WAS ALSO STATED THAT THE PATIENT EXPERIENCED HEMORRHAGE/BLEEDING. IT WAS UNKNOWN IF THE DEVICE CONTRIBUTED TO THE HEMORRHAGE/BLEEDING AT THIS TIME AND MEDICAL INTERVENTION WAS UNKNOWN. NO OTHER INFORMATION WAS AVAILABLE. AS PER FOLLOW-UP INFORMATION RECEIVED ON 30AUG2022, FOLEY CATHETER WAS REMOVED AND GOT STUCK ON THE WAY OUT CAUSING URETHRAL TRAUMA AND BLEEDING WITH REMOVAL AND POST REMOVAL . UPON INSPECTION OF THE CATHETER POST REMOVAL, THERE WERE WRINKLES AND ROLLS IN THE AREA WHERE THE BALLOON WAS INFLATED, FRANK BLOOD NOTED ON THE AREA AND IN THE TIP OF THE CATHETER. THE PATIENT ALSO EXPERIENCED URETHRA TISSUE BREAKDOWN WHILE THE CATHETER WAS INSERTED, DESPITE THE SECUREMENT OF THE CATHETER TO THE PATIENT'S THIGH, POSSIBLY DUE TO THE RIGID NATURE OF THE PRODUCT . IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

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

  MAUDE report 15418163 ↗
• MalfunctionMay 14, 2022Material Invagination; Material Twisted/Bent; Material Invagination; Material Twisted/Bent

  IT WAS REPORTED THAT THE FOLEY CATHETER HAD AN UNKNOWN ISSUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. PER FOLLOW-UP INFORMATION RECEIVED FROM (B)(6) TEAM ON 20APR2022, THE FOLEY CATHETER HAD A MATERIAL DEFORMATION PROBLEM AND MECHANICAL JAM PROBLEM. IT WAS ALSO STATED THAT THE PATIENT EXPERIENCED HEMORRHAGE/BLEEDING. IT WAS UNKNOWN IF THE DEVICE CONTRIBUTED TO THE HEMORRHAGE/BLEEDING AT THIS TIME AND MEDICAL INTERVENTION WAS UNKNOWN. NO OTHER INFORMATION WAS AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14402916 ↗
• MalfunctionMay 13, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE FOLEY CATHETER HAD AN UNKNOWN ISSUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. PER FOLLOW-UP INFORMATION RECEIVED FROM (B)(6) TEAM ON 20APR2022, THE FOLEY CATHETER HAD A MATERIAL DEFORMATION PROBLEM AND MECHANICAL JAM PROBLEM. IT WAS ALSO STATED THAT THE PATIENT EXPERIENCED HEMORRHAGE/BLEEDING. IT WAS UNKNOWN IF THE DEVICE CONTRIBUTED TO THE HEMORRHAGE/BLEEDING AT THIS TIME AND MEDICAL INTERVENTION WAS UNKNOWN. NO OTHER INFORMATION WAS AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14402641 ↗
• MalfunctionMar 31, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE USER EXPERIENCED SYMPTOMATIC URINARY TRACT INFECTION, PAIN AND LEAKAGE WHEN THEY WERE ASKED OF COMPLICATIONS WHILE USING THE FOLEY CATHETER. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR SYMPTOMATIC URINARY TRACT INFECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13970662 ↗
• InjuryMar 30, 2022Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE USER EXPERIENCED BACTERIURIA, SYMPTOMATIC URINARY TRACT INFECTION, PAIN, HEMATURIA, EPIDIDYMITIS, CATHETER BLOCKAGE, LEAKAGE, ACCIDENTAL REMOVAL AND BLADDER STONE(S) WHEN ASKED OF COMPLICATIONS WHILE USING THE FOLEY CATHETER. IT IS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Hematuria; Pain; Urinary Tract Infection

  MAUDE report 13952605 ↗
• InjuryMar 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURVEY RESPONDENT MENTIONED ABOUT BACTERIURIA, SYMPTOMATIC URINARY TRACT INFECTION, EPIDIDYMITIS, CATHETER BLOCKAGE AND LEAKAGE WHEN THEY WERE ASKED OF COMPLICATIONS WHILE USING THE FOLEY CATHETER. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

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

  MAUDE report 13942954 ↗
• InjuryMar 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE USER EXPERIENCED BACTERIURIA, SYMPTOMATIC URINARY TRACT INFECTION, HEMATURIA, CATHETER BLOCKAGE, LEAKAGE, ACCIDENTAL REMOVAL AND BLADDER STONES WHEN ASKED OF COMPLICATIONS WHILE USING THE FOLEY CATHETER. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hematuria; Urinary Tract Infection

  MAUDE report 13938813 ↗
• MalfunctionDec 31, 2021Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT SILICON CATHETER WAS NOT DRAINING THAT CAUSED LEAKING AND PATIENT GOT OVER FULL AND SPASMS IN THE NETHER REGIONS.

  Patient problems: Cramp(s) /Muscle Spasm(s)

  MAUDE report 13126905 ↗
• MalfunctionDec 29, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AT LEAST ONE OF THE FOLEY CATHETER TRAY RECEIVED WAS MISSING LUBRICANT. IT WAS ALSO REPORTED THAT THE FOLEY CATHETER WAS DEFECTIVE AS THE CATHETERS PATIENT HAD DID NOT DRAIN FOR A WEEK AND LEAKED. NURSE CHANGED THE FOLEY AND FOUND THE TIP LOOKED WEIRD AND THE HOLE WAS SMALL. IT WAS ALSO REPORTED THAT THE PATIENT'S CURRENT FOLEY CATHETER WAS ALSO LEAKING. IT WAS NOTED THAT THE PATIENT HAD BEEN USING THE PRODUCTS FOR LESS THAN 90 DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13111859 ↗
• MalfunctionDec 29, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT AT LEAST ONE OF THE FOLEY CATHETER TRAY RECEIVED WAS MISSING LUBRICANT. IT WAS ALSO REPORTED THAT THE FOLEY CATHETER WAS DEFECTIVE AS THE CATHETERS PATIENT HAD DID NOT DRAIN FOR A WEEK AND LEAKED. NURSE CHANGED THE FOLEY AND FOUND THE TIP LOOKED WEIRD AND THE HOLE WAS SMALL. IT WAS ALSO REPORTED THAT THE PATIENT'S CURRENT FOLEY CATHETER WAS ALSO LEAKING. IT WAS NOTED THAT THE PATIENT HAD BEEN USING THE PRODUCTS FOR LESS THAN 90 DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13111449 ↗
• MalfunctionDec 29, 2021Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT AT LEAST ONE OF THE FOLEY CATHETER TRAY RECEIVED WAS MISSING LUBRICANT. IT WAS ALSO REPORTED THAT THE FOLEY CATHETER WAS DEFECTIVE AS THE CATHETERS PATIENT HAD DID NOT DRAIN FOR A WEEK AND LEAKED. NURSE CHANGED THE FOLEY AND FOUND THE TIP LOOKED WEIRD AND THE HOLE WAS SMALL. IT WAS ALSO REPORTED THAT THE PATIENT'S CURRENT FOLEY CATHETER WAS ALSO LEAKING. IT WAS NOTED THAT THE PATIENT HAD BEEN USING THE PRODUCTS FOR LESS THAN 90 DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13111405 ↗
• MalfunctionNov 4, 2021Material Invagination; Material Invagination

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON DEVELOPED A RIDGE AND NURSING STAFF COULD NOT REMOVE THE CATHETER FROM THE PATIENT. IT WAS STATED THAT A UROLOGIST HAD TO BE CALLED IN AND CATHETER WAS FORCEFULLY REMOVED CAUSING DISCOMFORT AND BLEEDING IN THE PATIENT. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 12751224 ↗
• MalfunctionOct 22, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON BURST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12683768 ↗
• MalfunctionAug 10, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE CATHETER WAS TOO RIGID AND IT WAS DIFFICULT TO REMOVE. PATIENT EXPERIENCED BLEEDING AND TISSUE BREAKDOWN. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12300207 ↗
• InjuryJan 12, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE FOLEY CATHETER GOT STUCK WHEN IT WAS TRIED TO REMOVE, WHICH CAUSED URETHRAL TRAUMA AND BLEEDING WITH REMOVAL AND POST REMOVAL. UPON INSPECTION OF THE CATHETER POST REMOVAL THERE WERE WRINKLES AND ROLLS IN THE AREA WHERE THE BALLOON WAS INFLATED. BLOOD WAS NOTED IN THE TIP OF THE CATHETER. THE PATIENT ALSO EXPERIENCED URETHRA TISSUE BREAKDOWN WHILE THE CATHETER WAS INSERTED, DESPITE THE SECUREMENT OF THE CATHETER TO THIGH. THE USER STATED IT WAS POSSIBLY DUE TO THE RIGID NATURE OF THE PRODUCT. PER ADDITIONAL INFORMATION VIA IBC ON 23DEC2020, NURSE NOTED REDNESS AT CATHETER INSERTION SITE, HEMATURIA AND SMALL CLOTS. ON (B)(6) 2020 PATIENT COMPLAINED OF DISCOMFORT WITH BLADDER PRESSURE, NURSE IRRIGATED CATHETER WITH NO IMPROVEMENT AND REMOVED IT. CATHETER IN THE PHOTO SAMPLE WAS INSERTED. ON (B)(6) 2020, TEAR IN URETHRA WAS DOCUMENTED ALONG WITH FEELING OF BLADDER PRESSURE. BLADDER SCAN RESULT WAS 45ML. FLEX TRACK WAS USED TO REDUCE PRESSURE ON URETHRA. ON (B)(6) 2020, PATIENT COMPLAINED OF PAIN BOTH AT INSERTION SITE AND BLADDER AREA. FOLEY CATHETER REMOVED-25ML FROM BALLOON, COMPLETELY EVACUATED, AND ALLOWED TO REST BEFORE REMOVAL. PATIENT CRIED OUT IN PAIN

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Hematuria; No Consequences Or Impact To Patient

  MAUDE report 11154573 ↗
• InjuryJan 5, 2021Material Invagination; Difficult to Remove; Material Invagination; Difficult to Remove

  IT WAS REPORTED THAT THE FOLEY CATHETER GOT STUCK WHEN IT WAS TRYING TO REMOVE, WHICH CAUSED THE URETHRAL TRAUMA AND BLEEDING DURING REMOVAL AND POST REMOVAL. UPON INSPECTION DURING THE POST REMOVAL OF THE CATHETER THERE WERE WRINKLES AND ROLLS IN THE AREA WHERE THE BALLOON WAS INFLATED. THE BLOOD WAS NOTED IN THE TIP OF THE CATHETER. THE PATIENT ALSO EXPERIENCED A URETHRAL TISSUE BREAKDOWN WHILE THE CATHETER WAS INSERTED, DESPITE THE SECUREMENT OF THE CATHETER TO THE THIGH. THE USER STATED IT WAS POSSIBLY DUE TO THE RIGID NATURE OF THE PRODUCT. PER ADDITIONAL INFORMATION RECEIVED FROM THE IBC VIA EMAIL ON (B)(6)2020, THE NURSE NOTED THAT THE REDNESS AT THE CATHETER INSERTION SITE, HEMATURIA AND SMALL CLOTS. ON (B)(6)2020, THE PATIENT COMPLAINED OF DISCOMFORT WITH BLADDER PRESSURE, THE NURSE IRRIGATED THE CATHETER WITH NO IMPROVEMENT AND REMOVED IT. THE CATHETER IN THE PHOTO SAMPLE WAS INSERTED. ON (B)(6)2020, THE TEAR IN THE URETHRA WAS DOCUMENTED ALONG WITH FEELING OF BLADDER PRESSURE. THE BLADDER SCAN RESULT WAS 45ML. THE FLEX TRACK WAS USED TO REDUCE THE PRESSURE ON THE URETHRA. ON (B)(6)2020, THE PATIENT COMPLAINED OF PAIN, BOTH AT THE INSERTION SITE AND BLADDER AREA. THE FOLE

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

  MAUDE report 11120968 ↗
• MalfunctionJan 4, 2019Deflation Problem; Material Invagination; Material Invagination

  IT WAS REPORTED THAT THE CATHETER BALLOON DEFLATED AND WAS LATER FOUND TO BE PULLED BEYOND THE MEATUS. THE CATHETER WAS UNABLE TO BE PUSHED BACK TO RE-INFLATE. THERE WAS NO REPORTED PATIENT INJURY.

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

  MAUDE report 8216721 ↗
• MalfunctionMar 13, 2018Mushroomed; Inflation Problem; Mushroomed

  IT WAS REPORTED THAT THE USER COULD NOT KEEP THE BALLOON INFLATED DURING A PERIOD OF TWO DAYS. THE BALLOON LOST 30CC IN THAT TIME. PER THE SAMPLE EVALUATION, THERE WAS A MUSHROOM SHAPED BALLOON.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 7336170 ↗