Bardex® All-Silicone Foley Catheter 165820Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 00801741029776), received between May 9, 2017 and Apr 21, 2026 — classified as 7 injuries, 45 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (12 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 52 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2026Material Invagination; Difficult to Remove

  IT WAS REPORTED BY CUSTOMER THAT THE SILICONE FOLEY CATH THERE WAS A RIDGE ON THE CATHETER MAKES REMOVAL PAINFUL AND DIFFICULT.

  Patient problems: Pain

  MAUDE report 24941097 ↗
• MalfunctionApr 20, 2026Difficult to Insert

  IT WAS REPORTED THAT FOLEY CATHETER GOT STUCK WHEN INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24933068 ↗
• MalfunctionNov 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT SAID IT LEAKS. SAID THAT SHE NEEDS 24FR. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23452617 ↗
• InjuryJun 13, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT CUSTOMER PERFORMED MANUAL IRRIGATION ON FOLEY CATHETER PER ORDER. AFTER MANUALLY IRRIGATING AND PULLING BACK TO REMOVE CLOTS AND IRRIGATE FLUID, PATIENT STATED THAT THEY FELT A POP, SEVERAL MINUTES LATER FLUID BEGAN TO LEAK OUT OF PENIS AROUND THE FOLEY. SEVERAL MINUTES AFTER THAT PATIENT BEGAN TO REPORT PAIN THAT KEPT INCREASING. CUSTOMER CALLED FLOOR RESOURCE NURSE TO COME ASSIST AND FOLEY WAS COMING OUT. FOLEY CAME OUT WITH BALLOON DEFLATED. CUSTOMER CALLED DOCTOR FOR PAIN MEDICATIONS AND ORDER TO REPLACE FOLEY. FOLEY WAS PLACED EARLIER IN THE DAY, SO PACKAGING WAS NOT RETRIEVABLE. CUSTOMER GOT NUMBERS OFF OF FOLEY BAG AND BALLOON INFORMATION BUT UNSURE IF THESE WERE THE NUMBERS NEEDED. FOLEY BAG #PD7600167. BALLOON PORT #165820.

  Patient problems: Pain

  MAUDE report 22202344 ↗
• MalfunctionMay 13, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT FOLEY CATHETER BALLOON WOULD NOT INFLATE. THEY WERE NOT ABLE TO USE AND HAD TO OPEN ANOTHER PACKAGE. CUSTOMER WOULD LIKE CATHETER REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22008696 ↗
• MalfunctionApr 4, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE BALLOON OF FOLEY CATHETER WOULD NOT INFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21773655 ↗
• MalfunctionFeb 27, 2025Material Invagination; Material Invagination

  IT WAS REPORTED THAT BALLOON OF FOLEY CATHETER RETRACTED INTO ITSELF DURING REMOVAL, CREATING A BUMP RESULTING IN DIFFICULTY REMOVING THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21479855 ↗
• InjuryFeb 21, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED BARDEX ALL-SILICONE FOLEY CATHETER 20 CH/FR (6.7MM), 5CC RIBBED BALLOON, FROM BYRAM MEDICAL SUPPLIES. THE CATHETER WAS DEFECTIVE AND HAD TWO SMALL HOLES WHERE THE BAG¿S HOSE END WAS INSERTED. THE CUSTOMER WOULD ATTACH PHOTOS OF THE HOLES. THE CUSTOMER HAD RECEIVED SUPPLIES BY BARD IN THE PAST, BUT THIS IS THE FIRST TIME THAT WE FOUND ONE TO BE DEFECTIVE. ON (B)(6) 2025, OUR REGISTERED NURSE CAME TO CHANGE THE PATIENT SUPRA PUBIC CATHETER, AS IT WAS CHANGED EVERY FOUR WEEKS OR SOONER IF PROBLEMS WITH SEDIMENT. LATER IN THE AFTERNOON, AFTER FLUSHING THE CATHETER, THERE WAS A LOT OF WATER LEAKING, WHICH THEY THOUGHT WAS AS A RESULT OF IT BEING NEW AND STIFF, BUT AS CUSTOMER PUSHED THE BAG END FURTHER IN, THE LEAKING STOPPED. A COUPLE OF HOURS LATER, THE FLUSHED THE CATHETER AGAIN, AND AGAIN IT LEAKED ALSO PUSHED THE END OF THE BAG HOSE FURTHER IN AND THE LEAKING STOPPED. THIS TIME NOTICED TWO SMALL HOLES IN THE SILICONE WHERE THE BAG HOSE END WAS PUSHED. THE CAREGIVER NOW HAD TO WAIT UNTIL TUESDAY OF NEXT WEEK FOR THE NURSE TO CAME AND REPLACE THE DEFECTIVE CATHETER, AND PATIENT HAD TO GO THROUGH THE PAIN OF HAVING ANOTHER ONE INSERTED. THE C

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain; Pressure Sore/Ulcer

  MAUDE report 21432089 ↗
• MalfunctionFeb 20, 2025Material Invagination; Material Invagination

  IT WAS REPORTED THAT THE SILICONE FOLEY CATHETER BALLOON RETRACTED INTO ITSELF DURING REMOVAL CREATING A BUMP RESULTING IN DIFFICULTY REMOVING THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21421490 ↗
• InjuryFeb 14, 2025Material Invagination; Material Invagination

  IT WAS REPORTED THAT CUSTOMER REACHED OUT ON (B)(6) 2025, THAT THEY HAVE BEEN EXPERIENCING ISSUES WITH REMOVING FOLEY CATHETER ON POST-OP PATIENTS. THE NURSES HAVE NOTICED WHEN THEY DEFLATE THE BALLOON THE RIBBED BALLOON RETRACTS INTO ITSELF AND CREATES ALMOST LIKE A BUMPER OR STOPPER AND CAUSING PAIN AND PREVENTING THE CATHETER FROM BEING REMOVED EASILY FROM THE PATIENTS. THE SURGICAL PHYSICIAN ASSISTANT HAD TO COME DOWN AND REMOVE IT USING LUBRICANT AND SOME FORCE. THEY BORROWED THE BARDEX ALL-SILICONE FOLEY CATHETER FROM THE OPERATING ROOM TODAY TO TEST OUT AND SEE IF AFTER DEFLATING THE BALLOON IT DID THIS, AND THEY FOUND THAT IT WAS CREATING THIS STOPPER FROM THE BALLOON. THEY ALSO PLACED 3 IMPROVE NORTHS FOR THE 3 PATIENTS THAT IT OCCURRED WITH. THEY WERE UNSURE IF THIS WAS HAPPENING ON OTHER UNITS OR IN OTHER FACILITIES WITH THIS BRAND OF FOLEY CATHETER.

  Patient problems: Pain

  MAUDE report 21383728 ↗
• InjuryFeb 12, 2025Adverse 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 BY THE CRITICAL CARE NURSES THAT IN AN ONLINE SURVEY THE PATIENT EXPERIENCED ADVERSE EVENTS DIRECTLY CAUSED OR ATTRIBUTABLE TO THE USAGE OF FOLEY CATHETER RESULTED IN THE FOLLOWING COMPLICATIONS SUCH AS HEMATURIA. THE RESPONDENT INDICATED THEY BELIEVED THIS COMPLAINT TO BE PROCEDURE RELATED AND NOT DEVICE RELATED. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Hematuria

  MAUDE report 21363688 ↗
• InjuryFeb 11, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED BY THE CRITICAL CARE NURSES IN AN ONLINE SURVEY THAT THE PATIENT EXPERIENCED ADVERSE EVENTS DIRECTLY CAUSED / ATTRIBUTABLE TO THE USAGE OF DEVICE ALL-SILICONE FOLEY CATHETER, 2-WAY, STANDARD LENGTH, 5CC BALLOON, 20 FR. AND RESULTED IN THE FOLLOWING COMPLICATIONS: HEMATURIA, DISPLACEMENT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Hematuria

  MAUDE report 21354330 ↗
• MalfunctionFeb 7, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED BY THE CRITICAL CARE NURSES THAT IN AN ONLINE SURVEY SUCCESSFUL DRAINAGE OF URINE WAS NOT ACHIEVED FROM USE OF THIS FOLEY CATHETER BECAUSE OF LACK OF COMPLIANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21332659 ↗
• MalfunctionNov 26, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT A FEW DAYS AFTER PLACEMENT, URINE LEAKED FROM THE FUNNEL BRANCH OF THE FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20785135 ↗
• MalfunctionOct 1, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THERE WAS A HOLE IN THE FOLEY CATHETER WHILE TRYING TO INFLATE THE BALLOON. NORMALLY DON'T PREFILL THE BALLOON AS PER PRACTICE GUIDELINES, HOWEVER A MICROTEAR WAS OBSERVED IN THE LAST PRODUCT. SO, THE USER WANTED TO TEST AND OBSERVED A HOLE WHILE INFLATING THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20343837 ↗
• MalfunctionJul 1, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THEY HAVE BEEN SEEING ISSUES WITH A FEW OF OUR FOLEY CATHETERS (PCN #166818), (PCN #165820). FROM THE REPORT, IT SOUNDED LIKE WHEN TRYING TO REMOVE THE CATHETER, IT WAS GETTING STUCK AND CANNOT BE REMOVED UNLESS BY USING FORCE, WHICH WAS CAUSING TRAUMA AND BLEEDING TO THE PATIENT. THIS HAS HAPPENED TWICE JUST RECENTLY; ONE EVENT FOR EACH OF THE FOLEY CATHETERS MENTIONED PREVIOUSLY. THE BALLOON WAS BEING APPROPRIATELY DEFLATED AND EVEN ATTEMPTS AT PULLING BACK PRESSURE ON THE SYRINGE TO GET IT TO DEFLATE MORE DID NOT WORK. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 19646021 ↗
• MalfunctionJun 13, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT WHILE INSERTING AN 18 FR CATHETER IN A PATIENT WITH HYPERALGESIC URINARY RETENTION, THE URINE DID RETURN. THE NURSE INFLATED THE BALLOON WITH 10ML OF STERILE WATER BUT WHEN THE NURSE MOBILIZED THE CATHETER, IT DID NOT STAY IN PLACE. WHEN THEY TRIED THE SECOND TIME WITH 20ML OF STERILE WATER, THE SAME INCIDENT OCCURRED AGAIN. THEY TRIED SEVERAL TIMES INJECTING STERILE WATER MORE SLOWLY, CHANGING THE BATCH OR INSERTING A 20FR PROBE, BUT THEY COULD NOT SUCCEED. THE PATIENT ALSO FELT THE BALLOON POP ONCE. THE USER ALSO CARRIED OUT BLANK TESTS OUTSIDE THE PATIENT AND THE BALLOON WAS ALSO PUNCTURING. AFTER SEVERAL ATTEMPTS, THEY SUCCEEDED IN INSERTING THE URINARY CATHETER. THE CUSTOMER USED 165820CE, AND 165818CE WITH BATCHES MYGQ1137 AND MYEY1462. THE PACKAGING OF OTHER UNKNOWN BATCHES WERE NOT PRESERVED, AND THE PROBES ARE AVAILABLE FROM THE PHARMACY FOR EXPERT APPRAISAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19527604 ↗
• MalfunctionJun 13, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT WHILE INSERTING AN 18 FR CATHETER IN A PATIENT WITH HYPERALGESIC URINARY RETENTION, THE URINE DID RETURN. THE NURSE INFLATED THE BALLOON WITH 10ML OF STERILE WATER BUT WHEN THE NURSE MOBILIZED THE CATHETER, IT DID NOT STAY IN PLACE. WHEN THEY TRIED THE SECOND TIME WITH 20ML OF STERILE WATER, THE SAME INCIDENT OCCURRED AGAIN. THEY TRIED SEVERAL TIMES INJECTING STERILE WATER MORE SLOWLY, CHANGING THE BATCH OR INSERTING A 20FR PROBE, BUT THEY COULD NOT SUCCEED. THE PATIENT ALSO FELT THE BALLOON POP ONCE. THE USER ALSO CARRIED OUT BLANK TESTS OUTSIDE THE PATIENT AND THE BALLOON WAS ALSO PUNCTURING. AFTER SEVERAL ATTEMPTS, THEY SUCCEEDED IN INSERTING THE URINARY CATHETER. THE CUSTOMER USED 165820CE, AND 165818CE WITH BATCHES MYGQ1137 AND MYEY1462. THE PACKAGING OF OTHER UNKNOWN BATCHES WERE NOT PRESERVED, AND THE PROBES ARE AVAILABLE FROM THE PHARMACY FOR EXPERT APPRAISAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19527200 ↗
• MalfunctionJun 12, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT WHILE INSERTING AN 18 FR CATHETER IN A PATIENT WITH HYPERALGESIC URINARY RETENTION, THE URINE DID RETURN. THE NURSE INFLATED THE BALLOON WITH 10ML OF STERILE WATER BUT WHEN THE NURSE MOBILIZED THE CATHETER, IT DID NOT STAY IN PLACE. WHEN THEY TRIED THE SECOND TIME WITH 20ML OF STERILE WATER, THE SAME INCIDENT OCCURRED AGAIN. THEY TRIED SEVERAL TIMES INJECTING STERILE WATER MORE SLOWLY, CHANGING THE BATCH OR INSERTING A 20FR PROBE, BUT THEY COULD NOT SUCCEED. THE PATIENT ALSO FELT THE BALLOON POP ONCE. THE USER ALSO CARRIED OUT BLANK TESTS OUTSIDE THE PATIENT AND THE BALLOON WAS ALSO PUNCTURING. AFTER SEVERAL ATTEMPTS, THEY SUCCEEDED IN INSERTING THE URINARY CATHETER. THE CUSTOMER USED 165820CE, AND 165818CE WITH BATCHES MYGQ1137 AND MYEY1462. THE PACKAGING OF OTHER UNKNOWN BATCHES WERE NOT PRESERVED, AND THE PROBES ARE AVAILABLE FROM THE PHARMACY FOR EXPERT APPRAISAL. PER SAMPLE RETURN ON (B)(6) 2024, THE RECEIVED SAMPLE DID NOT MATCH WITH THE REPORTED MATERIAL NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19518532 ↗
• MalfunctionNov 15, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT IN FOLEY CATHETER ABLE TO PUSH WATER IN, AND THE BALLOON BLOWED UP. UNABLE TO DRAW THE LIQUID OUT. ALL CATHETERS FROM THE SAME LOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18139258 ↗
• MalfunctionOct 12, 2023Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THE STERILE WATER LEAKED FROM THE FOLEY CATHETER AFTER PLACEMENT. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 04OCT2023, THE USER STATED THAT THE LEAK HAPPENED AROUND THE BASE OF THE INFLATION VALVE BUT THEY COULD NOT FIND THE EXACT LOCATION OF LEAK AND THERE WAS NO VISIBLE DAMAGE ON THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17919549 ↗
• MalfunctionMar 9, 2023Burst Container or Vessel; Material Puncture/Hole; Burst Container or Vessel; Material Puncture/Hole

  IT WAS REPORTED THAT THE CATHETER BALLOON HAD BEEN RUPTURED BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16514192 ↗
• InjuryMay 5, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE SURVEY RESPONDENT MENTIONED ABOUT BACTERIURIA, HEMATURIA WHEN THEY WERE ASKED OF THE COMPLICATIONS FACED WHILE USING THE BARDIA SILICONE FOLEY CATHETER. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

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

  MAUDE report 14287411 ↗
• MalfunctionMar 29, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE USER EXPERIENCED BACTERIURIA, PAIN, HEMATURIA. ALSO THE CATHETER WAS BLOCKED AND HAD LEAKAGE. STATED THAT THE FOLEY CATHETER WAS ACCIDENTALLY REMOVED WHILE USING. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13943828 ↗
• InjuryMar 29, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE USER EXPERIENCED BACTERIURIA, PAIN, HEMATURIA. ALSO THE CATHETER WAS BLOCKED AND HAD LEAKAGE. STATED THAT THE FOLEY CATHETER WAS ACCIDENTALLY REMOVED WHILE USING. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

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

  MAUDE report 13943809 ↗