Bardex® All-Silicone Foley Catheter 165816Recalls & reported problems

Summary

The FDA's MAUDE database contains 512 adverse event reports that list this exact device (DI 00801741029752), received between Apr 10, 2017 and Sep 30, 2026 — classified as 44 injuries, 468 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (75 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 512 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954483 ↗
• MalfunctionJul 30, 2026Sharp Edges

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50092631 ↗
• MalfunctionJul 27, 2026Inflation Problem; Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50039143 ↗
• MalfunctionJul 27, 2026Material Puncture/Hole; Material Rupture

  It was reported that at around 14:00 hrs, prior to patient being transferred from bed to wheelchair, patient's incontinent brief was noted to be soiled. Both PCA and primary nurse intended to provide perineal care prior to transfer. Upon opening brief, foley catheter came out. Foley catheter tip noted to not be inflated. Balloon area was flat. Patient informed primary nurse that the catheter was inserted the day before. Primary nurse assessed foley catheter but using 10 ml syringe and trying to inflate it. No balloon inflation noted, instead, leakage noted. At the time primary nurse inserted a brand-new catheter of the same product. Balloon was inflated of 10 ml. Resistance noted. Urine output noted. One day later, at around 09:30 hrs, foley catheter was initially insitu until during med pass as patient was complaining of discomfort from foley catheter. Patient felt as if foley was not in place. Primary nurse assessed and tugged on catheter with no resistance noted. Primary nurse removed.

  Patient problems: Discomfort

  MAUDE report 50022111 ↗
• MalfunctionJul 21, 2026Inflation Problem; Material Puncture/Hole; Material Rupture

  IT WAS REPORTED THAT AT AROUND 14:00 HRS, PRIOR TO PATIENT BEING TRANSFERRED FROM BED TO WHEELCHAIR, PATIENT'S INCONTINENT BRIEF WAS NOTED TO BE SOILED. BOTH PCA AND PRIMARY NURSE INTENDED TO PROVIDE PERINEAL CARE PRIOR TO TRANSFER. UPON OPENING BRIEF, FOLEY CATHETER CAME OUT. FOLEY CATHETER TIP NOTED TO NOT BE INFLATED. BALLOON AREA WAS FLAT. PATIENT INFORMED PRIMARY NURSE THAT THE CATHETER WAS INSERTED THE DAY BEFORE. PRIMARY NURSE ASSESSED FOLEY CATHETER BUT USING 10 ML SYRINGE AND TRYING TO INFLATE IT. NO BALLOON INFLATION NOTED, INSTEAD, LEAKAGE NOTED. AT THE TIME PRIMARY NURSE INSERTED A BRAND-NEW CATHETER OF THE SAME PRODUCT. BALLOON WAS INFLATED OF 10 ML. RESISTANCE NOTED. URINE OUTPUT NOTED. ONE DAY LATER, AT AROUND 09:30 HRS, FOLEY CATHETER WAS INITIALLY INSITU UNTIL DURING MED PASS AS PATIENT WAS COMPLAINING OF DISCOMFORT FROM FOLEY CATHETER. PATIENT FELT AS IF FOLEY WAS NOT IN PLACE. PRIMARY NURSE ASSESSED AND TUGGED ON CATHETER WITH NO RESISTANCE NOTED. PRIMARY NURSE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25884686 ↗
• MalfunctionJul 19, 2026Sharp Edges

  Patient problems: Hematuria; Insufficient Information

  MAUDE report 25867755 ↗
• MalfunctionJul 19, 2026Sharp Edges

  IT WAS REPORTED THAT DURING USE THERE WERE COMPLAINTS FROM VARIOUS PARTS OF THE OR ABOUT THIS BARDEX ALL-SILICONE 2-WAY URINARY FOLEY CATHETER. THEY WERE ALSO SEEING AN INCREASED NUMBER OF PATIENTS WITH HEMATURIA, AND IT WAS ASKED IF THERE HAD ANY RECENT CHANGES TO THE CATHETER. NOTHING WAS FOUND ABOUT THAT IN THE FILE ONLY DOCUMENTED AT THE END OF 2024 DID NOT SAW ANY SUPPLIED ALTERNATIVES. THIS CONCERNS LOT MYKZ2589 AND STILL HAD STOCK. THEY ARE WILLING TO CONTACT BD REGARDING THE ISSUE OR PERHAPS IF A SALES REPRESENTATIVE OR PRODUCT SPECIALIST COULD ASSIST WITH THIS ISSUE.PER FOLLOW UP INFORMATION RECEIVED VIA RCC ON 10JUL2026, STATED THAT RECEIVED SO MANY COMPLAINTS ABOUT HEMATURIA FOLLOWING INSERTION THAT THIS IS NOT AN ISOLATED CASE. THE COLLEAGUES ARE PARTICULARLY SURPRISED BY THE SHAPE OF THE CATHETER, THE MULTIPLE RIDGES AND ARE WONDERING IF THEY¿RE DOING SOMETHING WRONG. PERHAPS IT WOULD BE BETTER IF YOU GAVE ME A QUICK CALL OR POPPED IN SOMETIME?PER FOLLOW UP INFORMATION RECEIVED ON 07/16/26, STATED THAT VISITED THE CLIENT TODAY AND SPOKE WITH VARIOUS DEPARTMENTS IN THE OR: SURGERY, CARDIOLOGY, AND UROLOGY. THEY ALL HAVE THE SAME PROBLEM: A DAMAGED URETHRA AFTER INSERTIN

  Patient problems: Hematuria; Insufficient Information

  MAUDE report 25867748 ↗
• MalfunctionJul 19, 2026Sharp Edges

  Patient problems: Hematuria; Insufficient Information

  MAUDE report 25867747 ↗
• MalfunctionMay 29, 2026Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY CATHETER REPLACED 2 TIMES ON PATIENT DURING NIGHT SHIFT DUE TO BALLOON LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25340011 ↗
• MalfunctionMay 15, 2026Difficult to Remove

  IT WAS REPORTED THAT THE NURSE WENT TO REMOVE THE CATHETER, THEY TRIED TO DEFLATE THE BALLOON OF THE CATHETER FOR A CHANGE, AND THE FLUID WAS NOT COMING BACK. THEY CALLED THE DOCTOR AND STILL COULD NOT GET THE FLUID TO COME OUT OF THE HUB THAT WAS ON THERE. THEY TRIED CUTTING THE HUB, BUT STILL THE WATER DID NOT RELEASE OUT OF THE BALLOON. BY THE END, THE DOCTOR HAD TO MANUALLY PULL THE CATHETER OUT OF THE PATIENT STILL INFLATED.

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

  MAUDE report 25191586 ↗
• MalfunctionMay 6, 2026Material Puncture/Hole

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE FOLEY CATHETER HAD A HOLE IN THE BALLOON FOR TWO DIFFERENT KITS. TWICE THE FOLEY CAME OUT AFTER INSERTION. PER FOLLOW-UP INFORMATION RECEIVED VIA EMAIL, ISSUE OCCURRED DURING A PROCEDURE, TWICE THE FOLEY CAME OUT AFTER INSERTION; THEY INSERTED A THIRD FOLEY FROM A DIFFERENT LOT NUMBER. A HERO WAS FILED. LOT# NGKW0653 ((B)(4) EA) / NGKY3546.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25096389 ↗
• MalfunctionApr 15, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PATIENT HAD INDICATION FOR FOLEY CATHETER. FOLEY CATHETER PLACED BY REGISTERED NURSE. WHEN INFLATING THE BALLOON WITH SALINE, THERE WAS A HOLE NEAR WHERE THE SALINE SYRINGE ATTACHES. FOLEY CATHETER REMOVED AND NEW ONE WAS PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24890274 ↗
• MalfunctionApr 14, 2026Unclear Information; Wrong Label

  IT WAS REPORTED THAT THE PACKAGING AND PRODUCT LABELING WAS MISLEADING. CATHETER PACKAGING PRINTED WITH 5CC RIBBED BALLOON. WHEREAS CATHETER PRINTED TO INFLATE TO 10ML. IF NURSING UNDER INFLATES CATHETER BALLOON (5CC/ML) THEY RISK POTENTIAL DISLODGEMENT AND URETER INJURY, URINE BYPASSING, SKIN INTEGRITY ISSUES, AND ADDED WORKLOADS. PRODUCT WAS AVAILABLE FOR INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24879384 ↗
• InjuryMar 30, 2026Material Invagination

  IT WAS REPORTED THAT THE PHYSICIANS HAVE RECENTLY ENCOUNTERED DIFFICULTY REMOVING BARD FOLEY CATHETERS IN TWO SEPARATE PATIENTS. IN BOTH CASES, THE BALLOON DID DEFLATE. HOWEVER, IT APPEARED TO LEAVE A RESIDUAL RIM OR CUFF THAT MADE CATHETER REMOVAL CHALLENGING. GIVEN THAT THIS HAS NOW OCCURRED MORE THAN ONCE, WE WOULD LIKE TO SPEAK DIRECTLY WITH SOMEONE WHO HAS DETAILED KNOWLEDGE OF THE PRODUCT¿S DESIGN AND BALLOON MECHANICS TO BETTER UNDERSTAND WHETHER THIS IS A KNOWN ISSUE AND HOW TO PREVENT IT. THEY ARE HOPING TO CONNECT WITH SOMEONE BEYOND A GENERAL REPRESENTATIVE IDEALLY A CLINICAL OR PRODUCT SPECIALIST WHO CAN ADDRESS THIS SPECIFIC CONCERN.PER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 20MAR2026, ON (b)(6) 2026, PATIENT 1 PRESENTED FOR SUPRAPUBIC TUBE (SPT) EXCHANGE WITH A FOLEY CATHETER, AS HAD BEEN PREVIOUSLY PERFORMED IN OFFICE. DESPITE BALLOON DEFLATION AND APPLICATION OF APPROPRIATE TRACTION, THE CATHETER COULD NOT BE REMOVED. THE PATIENT WAS SUBSEQUENTLY TAKEN TO THE OPERATING ROOM THE FOLLOWING DAY. AT THAT TIME, THE BALLOON WAS AGAIN DEFLATED AND THE CATHETER WAS REMOVED, WITH VISUALIZATION OF A RESIDUAL CUFF OF BALLOON MATERIAL DESPITE FULL DEFLATION. FOR PATIENT 1,

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

  MAUDE report 24715465 ↗
• MalfunctionMar 26, 2026Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING USE THE FOLEY CATHETERS ARE LEAKING AND THE PROBLEM HAD OCCURRED MORE FREQUENTLY. THE CATHETER WAS INSERTED, WHICH TURNED OUT TO BE LEAKING AT THE JUNCTION BETWEEN THE BALLOON INFLATION TUBE AND THE CATHETER BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24708520 ↗
• MalfunctionMar 10, 2026Material Puncture/Hole

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE FOLEY CATHETER HAD A HOLE IN THE BALLOON FOR TWO DIFFERENT KITS. TWICE THE FOLEY CAME OUT AFTER INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24562620 ↗
• MalfunctionFeb 26, 2026Inflation Problem

  IT WAS REPORTED THAT DURING USE THE FOLEY CATHETER BALLOON CANNOT BE INFLATED AND WATER COMING OUT INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24464047 ↗
• MalfunctionFeb 18, 2026Complete Blockage

  IT WAS REPORTED THAT THE CUSTOMER CALLED ABOUT CATH 57165816 HAD A BLOCKAGE AND NEEDS A REPLACEMENT LOT# NGKU4025...PROCESSED PU/EX. THEN CUSTOMER STATED SHE NEEDS THE DRAIN BAG REPLACED AS WELL ASKED WAS IT AN ISSUE WITH THE DRAIN BAG AND SHE STATED NO YOU CAN'T USE THE SAME DRAIN BAG WITH THE SAME CATH...PLACED ON HOLD AND CONFIRMED WITH SUP AND SHE STATED WE DON'T CHANGE THE DRAIN BAG WHEN IT'S AN ISSUE WITH THE FOLEY CATH AND WHILE ON HOLD SHE HUNG UP INFORMED THAT THE DRAIN BAGS IS NOT CHANGED OUT IF SHE HAS AN ISSUE WITH THE CATH AND SHE STATED WELL IF YOU'RE NOT GOING TO SEND ANOTHER DRAIN BAG THAT IS FINE I'M NOT USING THE SAME BAG WITH THE SAME CATH AND THE CALL WAS BRANDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24378842 ↗
• MalfunctionFeb 12, 2026Wrong Label

  IT WAS REPORTED THAT THE PATIENTS NURSE CALLED AND ADVISED THAT THE STICKER ON THE FOLEY CATHETER ITSELF TOLD THEM THE BALLOON SIZE WAS 5ML, BUT THE BOX WAS STATED IT WAS 10ML, THE CATHETER DID IN FACT HAD A 10ML BALLOON AND NOT A 5ML BALLOON. THE STICKER WAS INCORRECT. NO MEDICAL OR SURGICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24324356 ↗
• MalfunctionJan 30, 2026Material Rupture

  IT WAS REPORTED THAT THE PATIENT CALLED HOME CARE TO REPORT THE BALLOON IN THEIR FOLEY CATHETER BURSTED "HE HEARD A POP" THEN THE CATHETER FELL OUT. CUSTOMER THEN BOOKED AN APPOINTMENT WITH HOME CARE AND BROUGHT THE CATHETER IN. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

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

  MAUDE report 24228796 ↗
• MalfunctionJan 28, 2026Inflation Problem

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON FAILED TO INFLATE AFTER INSERTION. ATTEMPTS TO REPOSITION THE CATHETER WERE UNSUCCESSFUL, AND RESISTANCE PERSISTED. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24206301 ↗
• InjuryJan 28, 2026Material Rupture

  IT WAS REPORTED THAT FOR THE SECOND TIME FOLEY CATHETER WAS BURST INSIDE THE CUSTOMER, FIRST TIME THE TICKET WAS. CUSTOMER HAD TO GO TO THE EMERGENCY ROOM AND HE WAS BLEEDINGS. FOLEY CATHETER WAS PLACED ON (B)(6) 2026 AND (B)(6) 2026 IT BURST. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

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

  MAUDE report 24206107 ↗
• MalfunctionJan 26, 2026Difficult to Remove

  IT WAS REPORTED THAT THE INCIDENT HAD HAPPENED ON (B)(6) 2026 MORNING. A PATIENT UNDERWENT TURBT WITH CHEMO INSTILLATION. THE FOLEY BALLOON COULD NOT BE DEFLATED FOR REMOVAL. THE UROLOGY ATTENDING ADJUSTED THE CATHETER BY INSERTING IT DEEPER, WHICH EVENTUALLY ALLOWED THE SALINE TO BE REMOVED AND THE BALLOON TO DEFLATE, ENABLING CATHETER REMOVAL. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24185879 ↗
• MalfunctionJan 20, 2026Material Puncture/Hole

  IT WAS REPORTED THAT THE BALLOON LEAKED AND THE FOLEY CATHETER CAME OUT. WHICH WAS VERY PAINFUL. PATIENT HAD ALZHEIMER¿S AND ALSO HAD TO USE THE CATHETER BECAUSE THEY HAD A PROSTATE PROBLEM. THAT WAS VERY CHALLENGING AND COMPLICATED AND THEIR LIFE DEPENDS ON THE CATHETER. THAT HAD OCCURRED 6 TIMES OVER A 2.5-WEEK PERIOD. (B)(6) WAS CHANGED AFTER 12 WEEKS OF USE. THE FAILURE HAS BEEN FILED ON THE FOLLOWING DATES: (B)(6) 2025 (LOT # NGJT1652); (B)(6) 2025; (B)(6) 2025; (B)(6) 2025; (B)(6) 2026; (B)(6) 2026.

  Patient problems: Pain

  MAUDE report 24125941 ↗
• MalfunctionJan 20, 2026Material Puncture/Hole

  IT WAS REPORTED THAT THE BALLOON LEAKED AND THE FOLEY CATHETER CAME OUT. WHICH WAS VERY PAINFUL. PATIENT HAD ALZHEIMER¿S AND ALSO HAD TO USE THE CATHETER BECAUSE THEY HAD A PROSTATE PROBLEM. THAT WAS VERY CHALLENGING AND COMPLICATED AND THEIR LIFE DEPENDS ON THE CATHETER. THAT HAD OCCURRED 6 TIMES OVER A 2.5-WEEK PERIOD. (B)(6) WAS CHANGED AFTER 12 WEEKS OF USE. THE FAILURE HAS BEEN FILED ON THE FOLLOWING DATES: (B)(6) 2025 (LOT#-NGJT1652); (B)(6) 2025; (B)(6) 2025; (B)(6) 2025; (B)(6) 2026; (B)(6) 2026.

  Patient problems: Pain

  MAUDE report 24125940 ↗