Bardex® All-Silicone Foley Catheter 166818Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00801741029813), received between Apr 13, 2017 and Jul 8, 2026 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Partial Blockage” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25752790 ↗
• MalfunctionApr 15, 2026Material Puncture/Hole

  IT WAS REPORTED BY THE RESOURCE NURSE WITH EMP, 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. PER ADDITIONAL INFORMATION RECEIVED ON 07APR2026, IT WAS REPORTED IT WAS 16 AND 18 WITH 5ML BULB AND 16 AND 18 WITH 30ML BULB". THEY CALLED THE CUSTOMER TO CLARIFY THIS INFORMATION. A 16 AND 18FR CATHETER WERE INSERTED INTO THE PATIENT AND FELL OUT THE SAME DAY. THE CUSTOMER INFLATED A 16, 18 FR WITH 5CC BALLOON AND 16,18FR 30CC BALLOON AT THEIR DESK AND THE BALLOONS ONLY INFLATED MOSTLY ON ONE SIDE. THEY SENT THE FOLEY INFLATION/DEFLATION INSTRUCTION SHEET AND ASKED IF THEY FOLLOWED THE INSTRUCTIONS WHEN INFLATING AND THEY SAID THEY DID. ASKED TO SEND A CONTAINER AND PREPAID LABEL AND THEY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24888901 ↗
• MalfunctionSep 26, 2025Material Invagination; Material Invagination

  IT WAS REPORTED THAT THE USER NOTICED A RIDGE ON THE RIM OF THE FOLEY CATHETER BALLOON ONCE IT WAS DEFLATED AFTER POST-SURGERY USAGE.

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

  MAUDE report 23155128 ↗
• MalfunctionJul 9, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FOLEY CATHETER WAS PLACED FOR INDUCTION AT 15:30 AND WAS CONFIRMED TO BE AN 18 FR WITH A 30CC BALLOON, INFLATED AS PER THE PROTOCOL WITH 60CC STERILE WATER. AT 16:25, THE PATIENT FELT A POP AND THE CATHETER BALLOON WAS FOUND TO BE POPPED INTERNALLY AND A SMALL PIECE OF BALLOON FRAGMENT REMAINED ATTACHED TO THE FOLEY TUBING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19702502 ↗
• MalfunctionJul 9, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FOLEY CATHETER WAS PLACED FOR INDUCTION AT 15:30 AND WAS CONFIRMED TO BE AN 18 FR WITH A 30CC BALLOON, INFLATED AS PER THE PROTOCOL WITH 60CC STERILE WATER. AT 16:25, THE PATIENT FELT A POP AND THE CATHETER BALLOON WAS FOUND TO BE POPPED INTERNALLY AND A SMALL PIECE OF BALLOON FRAGMENT REMAINED ATTACHED TO THE FOLEY TUBING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19702231 ↗
• 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 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 19645825 ↗
• MalfunctionApr 6, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT TWO OF THE FOLEY CATHETER BALLOONS WERE FOUND TO POP IN THE PAST TWO DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14022191 ↗
• InjuryMar 29, 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 SYMPTOMATIC URINARY TRACT INFECTION AND CATHETER BLOCKAGE WHEN ASKED OF COMPLICATIONS WHILE USING THE FOLEY CATHETER. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 13944368 ↗
• MalfunctionAug 26, 2020Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT SHORT SUPPLIED OF 1 UNIT FOR THE BOX OF 12 UNITS BARDEX WAS DELIVERED TO UMMI SURGICAL.

  Patient problems: No Patient Involvement

  MAUDE report 10454331 ↗
• MalfunctionSep 13, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE CATHETER LEAKED FROM AN UNDETERMINED AREA. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9036489 ↗
• MalfunctionFeb 20, 2018Inflation Problem

  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.

  Patient problems: No Information

  MAUDE report 7281890 ↗
• MalfunctionJul 18, 2017Mushroomed

  IT WAS REPORTED THAT UPON VISUAL INSPECTION OF THE RETURNED SAMPLE, IT WAS NOTED THAT THE BALLOON APPEARED TO BE MUSHROOMED.

  Patient problems: No Information

  MAUDE report 6723636 ↗
• MalfunctionJul 6, 2017Partial Blockage; Improper Flow or Infusion

  IT WAS REPORTED THAT THE CATHETER WAS ALLEGEDLY BLOCKED, AND URINE DID NOT FLOW TO THE BAG. THE NURSE HAD TO IRRIGATE EVERY TWO DAYS. THE CATHETER WAS INSERTED ON (B)(6) 2017. THE VISUAL INSPECTION NOTED THERE APPEARED TO BE CALCIFICATION INSIDE THE CATHETER UPON RETURN. THERE APPEARED TO BE A CUFF OR PARTIALLY INFLATED/RAISED SECTION AT THE TOP OF THE BALLOON.

  Patient problems: No Information

  MAUDE report 6689086 ↗
• MalfunctionJul 5, 2017Partial Blockage; Calcified

  IT WAS REPORTED THAT THE CATHETER WAS ALLEGEDLY BLOCKED. HOWEVER, URINE DID FLOW TO THE BAG. THE NURSE HAD TO IRRIGATE EVERY TWO DAYS. THE CATHETER WAS INSERTED ON (B)(6) 2017. A VISUAL INSPECTION NOTED THAT THERE APPEARED TO BE CALCIFICATION INSIDE THE CATHETER UPON RETURN. THERE ALSO APPEARED TO BE A CUFF OR PARTIALLY INFLATED/RAISED SECTION AT THE TOP OF THE BALLOON.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6688507 ↗
• MalfunctionJun 2, 2017Partial Blockage

  IT WAS REPORTED THAT THE CATHETER BECAME BLOCKED AND HAD TO BE REPLACED AFTER THREE DAYS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6607604 ↗
• MalfunctionMay 10, 2017Partial Blockage

  IT WAS REPORTED THAT CATHETER WAS BLOCKED.; HOWEVER, IT IS UNKNOWN IF URINE WAS RETURNED. IT WAS LATER REPORTED THAT THE URINE DID FLOW INTO THE BAG, ALTHOUGH THE NURSE HAD TO IRRIGATE EVERY TWO DAYS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6558566 ↗
• MalfunctionApr 13, 2017Partial Blockage

  IT WAS REPORTED THAT THE CATHETERS ALLEGEDLY HAD BLOCKED LUMENS, ALTHOUGH THEY WERE IRRIGATED FREQUENTLY. THE CATHETER WAS REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6491006 ↗