Bardex® All-Silicone Foley Catheter 165818Recalls & reported problems

Summary

The FDA's MAUDE database contains 85 adverse event reports that list this exact device (DI 00801741029769), received between Jun 2, 2017 and Sep 1, 2026 — classified as 8 injuries, 77 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (15 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 25 most recent of 85 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50547363 ↗
• MalfunctionApr 20, 2026Material Rupture; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING USE THE FOLEY CATHETER SPONTANEOUSLY DISLODGED, THE CUFF WAS TORN BY APPROXIMATELY 1 CM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24933312 ↗
• MalfunctionApr 7, 2026Material Puncture/Hole

  IT WAS REPORTED THAT DURING USE THE FOLEY CATHETER HAD SPONTANEOUS DISLODGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24800647 ↗
• MalfunctionFeb 17, 2026Difficult to Remove

  IT WAS REPORTED BY THE NURSE THAT THEY HAD USED THE SILICONE FOLEY CATHETER AND IT DID NOT DEFLATE. AS THEY STATED AND AS THEY SOUNDED, NO ONE WAS HURT, AND THEY JUST NEEDED TO OPEN A COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24366431 ↗
• MalfunctionDec 12, 2025Material Puncture/Hole; Material Split, Cut or Torn; Material Puncture/Hole; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS LEAKING, AND A HOLE WAS DETECTED ON Y CONNECTOR SIDE OF CATHETER.

  Patient problems: Exposure to Body Fluids; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23796949 ↗
• MalfunctionSep 29, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THIS WAS A FOLEY CATHETER DISLODGEMENT AFTER CATHETER PLACEMENT PLACED ON (B)(6) 2025 AND UPON CHECKING THE BALLOON, LEAKAGE WAS CONFIRMED. PER FOLLOW UP INFORMATION RECEIVED VIA RCC ON 26SEP2025, STATED THAT WHEN CHECKED THE FOLEY CATHETER BALLOON, IT WAS CONFIRMED THAT IT WAS LEAKING AS THE BALLOON WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23169388 ↗
• MalfunctionSep 29, 2025Material Puncture/Hole; Material Rupture; Material Puncture/Hole; Material Rupture

  IT WAS REPORTED THAT THIS WAS A FOLEY CATHETER SPONTANEOUS REMOVAL EVENT AFTER PLACEMENT IN A HOME CARE PATIENT PLACED FROM 19SEP2025. WHEN THE BALLOON WAS CHECKED, IT WAS FOUND TO BE LEAKING. AS MULTIPLE OCCURRENCES HAVE BEEN REPORTED IN THE SAME PATIENT, THERE MIGHT BE POSSIBILITY OF CALCIFICATION STONES, ETC. IN THE URINARY TRACT AND MONITORING TO SEE IF THIS WAS CAUSED BY THE LOT. PER FOLLOW UP INFORMATION RECEIVED VIA RCC ON 26SEP2025, STATED THAT AFTER LEAK A BROKEN BALLOON WAS CONFIRMED WHEN CHECKED THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23169377 ↗
• MalfunctionSep 29, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THIS WAS A FOLEY CATHETER SPONTANEOUS REMOVAL EVENT OCCURRED AFTER PLACEMENT IN A HOME-CARE PATIENT PLACED SINCE (B)(6) 2025. WHEN THE BALLOON WAS CHECKED, IT WAS FOUND TO BE LEAKING. PER FOLLOW UP INFORMATION RECEIVED VIA RCC ON 26SEP2025, STATED THAT AFTER LEAK A BROKEN BALLOON WAS CONFIRMED WHEN CHECKED THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23168181 ↗
• MalfunctionSep 2, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT PRODUCT HAD A HOLE IN FOLEY CATHETER BIFURCATION. (B)(4). PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 25SEP2025, IT WAS REPORTED THAT THE PRODUCT WAS ALREADY RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22941087 ↗
• MalfunctionAug 27, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DURING PLACEMENT, THE FOLEY CATHETER WAS PLACED ON (B)(6) AND NATURALLY REMOVED ON (B)(6). LEAK LOCATION WAS UNKNOWN. PER INTERNAL BD COMMENTS RECEIVED ON 22AUG2025, REPORTED THAT18FR SILICONE OR LATEX CATHETER. SINCE THE BALLOON DID NOT INFLATE EVEN AFTER BEING NATURALLY REMOVED, IT WAS POSSIBLE THAT THE BALLOON CATHETER WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22904061 ↗
• MalfunctionAug 14, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED BY THE PATIENT THAT THE FOLEY CATHETER FELL OUT. 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 22803817 ↗
• MalfunctionJun 10, 2025Material Rupture; Device Dislodged or Dislocated; Material Rupture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS PLACED IN THE PATIENT ON (B)(6) 2025 AND WAS NATURALLY REMOVED ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22176582 ↗
• MalfunctionMay 30, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING PLACEMENT THE FOLEY CATHETER WAS NATURALLY REMOVED WHILE IN THE PATIENT'S CARE, AND THE BALLOON WAS DAMAGED. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 16MAY2025, STATED THAT THE BALLOON WAS RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22114086 ↗
• MalfunctionMay 30, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING PLACEMENT, THE FOLEY CATHETER WAS REMOVED NATURALLY WHILE IN THE PATIENT'S CARE, AND THE BALLOON PART WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22113603 ↗
• MalfunctionMay 23, 2025Material Invagination; Material Invagination

  IT WAS REPORTED THAT THE FOLEY CATHETER MATERIAL WAS DIFFERENT (SOFTER) WHICH INCREASED FALSE PATHS, WAS MORE DIFFICULT TO INSERT, WHICH HURT THE PATIENT. CUSTOMER HAD A SITUATION WHERE THE CATHETER HAD MADE A KNOT IN THE BLADDER, AND THEY HAD TO DO A CYSTOSCOPY TO CUT THE CATHETER WITH A LASER TO REMOVE IT (PCN#175812, PCN#175814, PCN#175816, PCN#175818, PCN#175820, PCN#165822 AND PCN#175824). PER ADDITIONAL INFORMATION RECEIVED VIA MAIL ON 06MAY2025, THE TIP OF THE CATHETER THAT CONTAINS THE BALLOON IS PROMINENT AND FORMS A RING WHEN THE BALLOON IS DEFLATED. IT WAS ANOTHER ISSUE WITH THE DEFLATION OF THE BALLOON. THE BALLOON REMAINS DEFORMED WHEN DEFLATED, CAUSING INJURY TO THE PATIENT WHEN REMOVING THE INDWELLING CATHETER. THIS WAS APPARENTLY TRUE FOR ALL OUR 100% FOLEY (1658XX) AND LUBRI-SIL (1758XX) MODELS. (PCN# 165820, PCN# 165818 AND PCN# 165816). NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 22077925 ↗
• MalfunctionMay 21, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT HOLE IN FOLEY CATHETER BALLOON AND 2 FROM SAME LOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22061813 ↗
• MalfunctionApr 28, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT SMALL HOLES IN FOLEY CATHETER WALL AROUND THE LEVEL OF THE BIFURCATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21918146 ↗
• MalfunctionApr 7, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING THE PRE-TEST, HERE WAS A HOLE IN THE FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21785954 ↗
• MalfunctionApr 7, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING PLACEMENT THE FOLEY CATHETER WAS REMOVED NATURALLY WHILE IN USE, AND THE BALLOON PART WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21784536 ↗
• MalfunctionApr 4, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS PLACED ON (B)(6) 2025 AND DISCOVERED THAT IT HAD NATURALLY BEEN REMOVED DURING A DIAPER CHANGE ON (B)(6) 2025. THE STERILE WATER IN THE BALLOON PART HAD LEAKED OUT AND IT HAD TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21772175 ↗
• MalfunctionFeb 14, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT AN 18-FR SILICONE FOLEY CATHETER WAS PLACED. WHEN NURSE INFLATED THE BULB, THE HUB WAS INFLATED. FOLEY WAS REMOVED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21384469 ↗
• InjuryFeb 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CRITICAL CARE NURSES THAT IN AN ONLINE SURVEY STATED THE PATIENT EXPERIENCED ADVERSE EVENTS DIRECTLY CAUSED OR ATTRIBUTABLE TO THE USAGE OF DEVICE SILICONE FOLEY CATHETER, 2-WAY, STANDARD LENGTH, 5CC BALLOON, 18 FR AND RESULTED IN THE FOLLOWING COMPLICATIONS: BACTERIURIA OR URINARY TRACT INFECTION. THE RESPONDENT ALSO INDICATED NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED.

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

  MAUDE report 21363690 ↗
• MalfunctionFeb 11, 2025Calcified; Calcified

  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 BALLOON RUPTURE, URINE RETENTION, DYSURIA WITHOUT SUTI, URETHRA CUTANEOUS FISTULA, CATHETER ENCRUSTATION, PYELONEPHRITIS, BLOCKAGE, BLADDER SPASMS, SEPTICEMIA OR UROSEPSIS, IRRIGATION, HYDRONEPHROSIS, VESICOURETERAL REFLUX, IRRITATION. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21354333 ↗
• MalfunctionFeb 11, 2025Material Rupture; Material Rupture

  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 BALLOON RUPTURE, URINE RETENTION, DYSURIA WITHOUT SUTI, URETHRA CUTANEOUS FISTULA, CATHETER ENCRUSTATION, PYELONEPHRITIS, BLOCKAGE, BLADDER SPASMS, SEPTICEMIA OR UROSEPSIS, IRRIGATION, HYDRONEPHROSIS, VESICOURETERAL REFLUX, IRRITATION. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21354329 ↗
• InjuryFeb 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CRITICAL CARE NURSES REPORTED 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, 18 FR AND RESULTED IN THE FOLLOWING COMPLICATIONS: BALLOON RUPTURE, URINE RETENTION, CATHETER ENCRUSTATION, PYELONEPHRITIS, IRRIGATION, HYDRONEPHROSIS. FOR ALL OF THESE COMPLICATIONS THE RESPONDENT INDICATED THE PATIENT REQUIRED MEDICAL OR SURGICAL INTERVENTION, HOWEVER WHEN ASKED TO DESCRIBE THE MEDICAL OR SURGICAL INTERVENTION STATED NONE FOR EVERY COMPLICATION. ADDITIONALLY, THE NURSE STATED THAT THE PATIENT EXPERIENCED THE FOLLOWING ADVERSE EVENTS BUT INDICATED THEM TO BE PROCEDURE RELATED COMPLICATIONS: DYSURIA WITHOUT SYMPTOMATIC URINARY TRACT INFECTION, URETHROCUTANEOUS FISTULA, BLOCKAGE, BLADDER SPASMS, SEPTICEMIA/UROSEPSIS, VESICOURETERAL REFLUX, IRRITATION. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cramp(s) /Muscle Spasm(s); Dysuria; Fistula; Kidney Infection; Sepsis; Skin Inflammation/ Irritation; Urinary Retention

  MAUDE report 21344279 ↗