Bardex® All-Silicone Foley Catheter 165812Recalls & reported problems

Summary

The FDA's MAUDE database contains 151 adverse event reports that list this exact device (DI 00801741029738), received between May 17, 2017 and Jul 12, 2026 — classified as 11 injuries, 140 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (34 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 151 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 12, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25791139 ↗
• MalfunctionJul 8, 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 25752800 ↗
• MalfunctionJun 12, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING USE THE 12 CH/FR ALL SILICONE FOLEY CATHETER REF 165812, LOT# NGKR2139, EXPIRY 2029OCT31. THERE WERE NO ISSUES NOTED AT THE TIME OF IDC INSERTION; HOWEVER, URINE LEAKAGE WAS OBSERVED SHORTLY AFTERWARDS AT THE Y JUNCTION OF THE FOLEY CATHETER. THE IDC NEEDED TO BE REMOVED AND REPLACED WITH A NEW CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25493469 ↗
• MalfunctionMay 22, 2026Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED THAT, INSERTED IN PATIENT AND BALLOON DIDN'T INFLATE AND FELL OUT OF PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25263013 ↗
• MalfunctionMay 15, 2026Inflation Problem

  IT WAS REPORTED THAT FOLEY CATHETER BALLOON EITHER DID NOT INFLATE OR DID NOT STAY INFLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25184574 ↗
• MalfunctionMay 15, 2026Inflation Problem

  IT WAS REPORTED THAT FOLEY CATHETER BALLOON EITHER DID NOT INFLATE AND OR DID NOT STAY INFLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25183913 ↗
• MalfunctionMay 14, 2026Material Puncture/Hole

  IT WAS REPORTED THAT FOLEY CATHETER BALLOON EITHER DID NOT INFLATE OR DID NOT STAY INFLATED (LOT NGLN1333) AND (LOT NGKX3806).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25174128 ↗
• MalfunctionMay 14, 2026Inflation Problem

  IT WAS REPORTED THAT THE URETHRAL BARD 12FR 2 WAY FOLEY BALLOON UNCOATED SILICONE 5CC STERILE LATEX FREE CATHETER BALLOON EITHER DOES NOT INFLATE OR DOES NOT STAY INFLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25174122 ↗
• MalfunctionMay 14, 2026Material Puncture/Hole

  IT WAS REPORTED THAT THE URETHRAL BARD 12FR 2 WAY FOLEY BALLOON UNCOATED SILICONE 5CC STERILE LATEX FREE CATHETER BALLOON EITHER DOES NOT INFLATE OR DOES NOT STAY INFLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25174120 ↗
• MalfunctionMay 10, 2026Material Puncture/Hole

  IT WAS REPORTED THAT FOLEY CATHETER BALLOON EITHER DID NOT INFLATE OR DID NOT STAY INFLATED (LOT NGLN1333) AND (LOT NGKX3806).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25133604 ↗
• MalfunctionMay 10, 2026Material Puncture/Hole

  IT WAS REPORTED THAT CUSTOMER HAD SEVERAL COMPLAINTS FROM NURSING THAT THE FOLEY CATHETER BALLOON EITHER DOES NOT INFLATE OR DOES NOT STAY INFLATED. THEY TRIED 4 TO 5 DIFFERENT CATHETERS FROM THE SAME LOT NUMBER THAT ALL SUFFERED THE SAME FAILURE. ALSO REPORTED THAT ONE SAMPLE WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25133602 ↗
• MalfunctionMay 10, 2026Inflation Problem

  IT WAS REPORTED THAT CUSTOMER HAD SEVERAL COMPLAINTS FROM NURSING THAT THE FOLEY CATHETER BALLOON EITHER DOES NOT INFLATE OR DOES NOT STAY INFLATED. THEY TRIED 4 TO 5 DIFFERENT CATHETERS FROM THE SAME LOT# THAT ALL SUFFERED THE SAME FAILURE. ALSO REPORTED THAT ONE SAMPLE WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25133600 ↗
• MalfunctionMay 10, 2026Material Rupture

  IT WAS REPORTED BY CUSTOMER THAT THE CATHETER BALLOON FAILED AND POPPED UPON INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25133576 ↗
• MalfunctionMay 3, 2026Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT THE CUSTOMER STATED THE FOLEY CATHETER BALLOON DID NOT DEFLATE. THE CUSTOMER WAS PROVIDED WITH RECOMMENDATIONS. THE ATTACHED CASE REPORT WAS REFERENCED FOR ADDITIONAL DETAILS, THE INVESTIGATION WAS INITIATED, AND THE CUSTOMER WAS INFORMED OF THE NEXT STEPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25062973 ↗
• MalfunctionMay 1, 2026Material Rupture

  IT WAS REPORTED THAT IN THE OR THE FOLEY BALLOON DID NOT DEFLATE TO REMOVE THE FOLEY. THE CLINICIANS CALLED THE PHYSICIAN ON CALL TO ASK WHAT TO DO AND WERE TOLD TO INSTILL 10 CC OF MINERAL WATER INTO THE BALLOON TO GET IT DEFLATE, WHEN DOING SO, THE BALLOON RUPTURED INSIDE THE PATIENT. THE RISK MANAGEMENT DEPARTMENT REPORTED THE INCIDENT TO THE FDA. THE PATIENT IS OKAY BUT HAS BEEN ADVISED TO CONTINUE TO KEEP AN EYE ON THINGS AND RETURNED TO BE SEEN IF ANYTHING COMES UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25060791 ↗
• MalfunctionMay 1, 2026Difficult to Remove

  IT WAS REPORTED THAT IN THE OR THE FOLEY BALLOON DID NOT DEFLATE TO REMOVE THE FOLEY. THE CLINICIANS CALLED THE PHYSICIAN ON CALL TO ASK WHAT TO DO AND WERE TOLD TO INSTILL 10 CC OF MINERAL WATER INTO THE BALLOON TO GET IT DEFLATE, WHEN DOING SO, THE BALLOON RUPTURED INSIDE THE PATIENT. THE RISK MANAGEMENT DEPARTMENT REPORTED THE INCIDENT TO THE FDA. THE PATIENT IS OKAY BUT HAS BEEN ADVISED TO CONTINUE TO KEEP AN EYE ON THINGS AND RETURNED TO BE SEEN IF ANYTHING COMES UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25060774 ↗
• MalfunctionMar 7, 2026Material Puncture/Hole

  IT WAS REPORTED THAT DURING USE THE FOLEY CATHETER DISLODGED BY ITSELF. FEW RANDOM CATHETERS WERE ADMINISTERED AND UPON REGULAR CHECK BY NURSES REALIZED THAT THE CATHETERS HAD DISLODGED AND THAT THE BALLOONS WERE DEFLATED WITHOUT CLINICAL INTERVENTION AND LOT NUMBER UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24539930 ↗
• MalfunctionFeb 25, 2026Material Rupture

  IT WAS REPORTED THAT DURING INFLATION WITH FLUID, THE FOLEY CATHETER BALLOON RUPTURED. THAT OCCURRED TWICE WHILE IN THEATRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24444433 ↗
• InjuryFeb 6, 2026Difficult to Remove

  IT WAS REPORTED THAT DURING USE OF FOLEY CATHETER, CUSTOMER WAS UNABLE TO EMPTY THE FILLED BALLOON, SO THEY CUT THE CATHETER IN HALF TO EMPTY IT.

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

  MAUDE report 24278722 ↗
• MalfunctionJan 23, 2026Material Rupture

  IT WAS REPORTED THAT DURING THE OPERATION, THE CUFF CHECK AND THE FIXATION WATER DURING INSERTION WERE FINE, BUT THE FOLEY CATHETER CAME OUT DURING WOUND CLOSURE, AND UPON INSPECTION, A SCRATCH WAS FOUND ON THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24172262 ↗
• MalfunctionDec 30, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT SEVERAL HOURS AFTER INSERTION STERILE WATER WAS LEAKING OUT DUE TO BACKFLOW. THERE WERE NO PROBLEMS DURING PRE TESTING, BUT THE STERILE WATER LEAK WAS DISCOVERED AFTER INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23930102 ↗
• MalfunctionDec 10, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE STERILE WATER LEAKED FROM THE DRAINAGE FUNNEL OF THE FOLEY CATHETER, AS IT WAS A LUMEN TO LUMEN LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23771529 ↗
• MalfunctionNov 11, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE CATHETER BALLOON WAS DEFECTIVE. THE NURSE STATED SHE FELT THE NORMAL PRESSURE OF INFLATING THE BALLOON, BUT WITH 2ML LEFT IN THE SYRINGE SHE FELT THAT THERE WAS SUDDENLY NO RESISTANCE AT ALL. IMMEDIATELY AFTER, THE CATHETER FELL OUT OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23523875 ↗
• MalfunctionNov 8, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON WAS NOT INFLATING CORRECTLY. SOMETIMES AS YOU ARE INJECTING THE WATER IN TO INFLATE THE BALLOON IT APPEARS TO GO THE WRONG WAY, SO NOT INTO THE BALLOON BUT DOWN THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23505187 ↗
• MalfunctionNov 7, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT, HAIR WAS FOUND WITHIN THE STERILE PACKAGING OF THE FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23495271 ↗