Bardex® All-Silicone Foley Catheter 165824Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00801741029790), received between Apr 4, 2018 and Feb 10, 2025 — classified as 4 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (3 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2025Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT CRITICAL CARE NURSES IN THE ONLINE SURVEY THE NURSE STATED THAT THE PATIENT EXPERIENCED ADVERSE EVENTS DIRECTLY CAUSED OR ATTRIBUTABLE TO THE USAGE OF DEVICE SILICONE FOLEY CATHETER, 2-WAY, STANDARD LENGTH, 5CC BALLOON, 24 FR. AND RESULTED IN THE FOLLOWING COMPLICATIONS: BLOCKAGE, URINE RETENTION, CATHETER ENCRUSTATION, AND FALSE PASSAGE OR TRAUMA. 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: BACTERIURIA OR URINARY TRACT INFECTION, ACCIDENTAL DISLODGEMENT, EXIT SITE INFECTION, LEAKAGE, PYELONEPHRITIS. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21344605 ↗
• 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 IN THE ONLINE SURVEY THE NURSE STATED THAT THE PATIENT EXPERIENCED ADVERSE EVENTS DIRECTLY CAUSED OR ATTRIBUTABLE TO THE USAGE OF DEVICE SILICONE FOLEY CATHETER, 2-WAY, STANDARD LENGTH, 5CC BALLOON, 24 FR. AND RESULTED IN THE FOLLOWING COMPLICATIONS: BACTERIURIA OR URINARY TRACT INFECTION, ACCIDENTAL DISLODGEMENT, BLOCKAGE, URINE RETENTION, EXIT SITE INFECTION, LEAKAGE, CATHETER ENCRUSTATION, FALSE PASSAGE OR TRAUMA, PYELONEPHRITIS. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.

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

  MAUDE report 21344280 ↗
• MalfunctionFeb 10, 2025Calcified; Calcified

  IT WAS REPORTED THAT THE CRITICAL CARE NURSES IN THE ONLINE SURVEY THE NURSE STATED THAT THE PATIENT EXPERIENCED ADVERSE EVENTS DIRECTLY CAUSED OR ATTRIBUTABLE TO THE USAGE OF DEVICE SILICONE FOLEY CATHETER, 2-WAY, STANDARD LENGTH, 5CC BALLOON, 24 FR. AND RESULTED IN THE FOLLOWING COMPLICATIONS: BLOCKAGE, URINE RETENTION, CATHETER ENCRUSTATION, AND FALSE PASSAGE OR TRAUMA. 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: BACTERIURIA OR URINARY TRACT INFECTION, ACCIDENTAL DISLODGEMENT, EXIT SITE INFECTION, LEAKAGE, PYELONEPHRITIS. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21344277 ↗
• MalfunctionFeb 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE CRITICAL CARE NURSES IN THE ONLINE SURVEY THE NURSE STATED THAT THE PATIENT EXPERIENCED ADVERSE EVENTS DIRECTLY CAUSED OR ATTRIBUTABLE TO THE USAGE OF DEVICE SILICONE FOLEY CATHETER, 2-WAY, STANDARD LENGTH, 5 CC BALLOON, 24 FR. AND RESULTED IN THE FOLLOWING COMPLICATIONS: BLOCKAGE, URINE RETENTION, CATHETER ENCRUSTATION, AND FALSE PASSAGE OR TRAUMA. 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: BACTERIURIA OR URINARY TRACT INFECTION, ACCIDENTAL DISLODGEMENT, EXIT SITE INFECTION, LEAKAGE, PYELONEPHRITIS. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21343308 ↗
• MalfunctionFeb 7, 2025Calcified; Calcified

  IT WAS REPORTED BY THE CRITICAL CARE NURSES THAT IN AN ONLINE SURVEY THE NURSE STATED THAT THE PATIENT EXPERIENCED ADVERSE EVENTS DIRECTLY CAUSED OR ATTRIBUTABLE TO THE USAGE OF DEVICE SILICONE FOLEY CATHETER, 2-WAY, STANDARD LENGTH, 5CC BALLOON, 24 FR. AND RESULTED IN THE FOLLOWING COMPLICATIONS: BACTERIURIA OR URINARY TRACT INFECTION, ACCIDENTAL DISLODGEMENT, BLOCKAGE, URINE RETENTION, EXIT SITE INFECTION, LEAKAGE, CATHETER ENCRUSTATION, FALSE PASSAGE OR TRAUMA, PYELONEPHRITIS. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21333492 ↗
• MalfunctionFeb 7, 2025Partial Blockage; Partial Blockage

  IT WAS REPORTED BY THE CRITICAL CARE NURSES THAT IN AN ONLINE SURVEY THE NURSE STATED THAT THE PATIENT EXPERIENCED ADVERSE EVENTS DIRECTLY CAUSED OR ATTRIBUTABLE TO THE USAGE OF DEVICE SILICONE FOLEY CATHETER, 2-WAY, STANDARD LENGTH, 5CC BALLOON, 24 FR. AND RESULTED IN THE FOLLOWING COMPLICATIONS: BACTERIURIA OR URINARY TRACT INFECTION, ACCIDENTAL DISLODGEMENT, BLOCKAGE, URINE RETENTION, EXIT SITE INFECTION, LEAKAGE, CATHETER ENCRUSTATION, FALSE PASSAGE OR TRAUMA, PYELONEPHRITIS. IT WAS UNFKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21333377 ↗
• InjuryFeb 7, 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 THE NURSE STATED THAT THE PATIENT EXPERIENCED ADVERSE EVENTS DIRECTLY CAUSED OR ATTRIBUTABLE TO THE USAGE OF DEVICE SILICONE FOLEY CATHETER, 2-WAY, STANDARD LENGTH, 5 CC BALLOON, 24 FR. AND RESULTED IN THE FOLLOWING COMPLICATIONS: BACTERIURIA OR URINARY TRACT INFECTION, ACCIDENTAL DISLODGEMENT, BLOCKAGE, URINE RETENTION, EXIT SITE INFECTION, LEAKAGE, CATHETER ENCRUSTATION, FALSE PASSAGE OR TRAUMA, PYELONEPHRITIS. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.

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

  MAUDE report 21333371 ↗
• MalfunctionFeb 7, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED BY THE CRITICAL CARE NURSES THAT IN AN ONLINE SURVEY THE NURSE STATED THAT THE PATIENT EXPERIENCED ADVERSE EVENTS DIRECTLY CAUSED OR ATTRIBUTABLE TO THE USAGE OF DEVICE SILICONE FOLEY CATHETER, 2-WAY, STANDARD LENGTH, 5CC BALLOON, 24 FR. AND RESULTED IN THE FOLLOWING COMPLICATIONS: BACTERIURIA OR URINARY TRACT INFECTION, ACCIDENTAL DISLODGEMENT, BLOCKAGE, URINE RETENTION, EXIT SITE INFECTION, LEAKAGE, CATHETER ENCRUSTATION, FALSE PASSAGE OR TRAUMA, PYELONEPHRITIS. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21332862 ↗
• MalfunctionJan 22, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT PATIENT SAID THE FOLEY CATHETER 5CC BALLOON KEPT DEFLATING.

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

  MAUDE report 21209325 ↗
• MalfunctionApr 6, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE SURVEY RESPONDENT MENTIONED BACTERIURIA AND FLEXIBILITY NOT ALWAYS ALLOWING TO CROSS A NARROWING OF THE URETHRA OR A VOLUMINOUS PROSTATE WHEN ASKED ABOUT COMPLICATIONS WHILE USING THE FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14022303 ↗
• InjuryApr 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUSTOMER MENTIONED ABOUT BACTERIURIA, SYMPTOMATIC URINARY TRACT INFECTION, PAIN AND HEMATURIA, CATHETER BLOCKAGE AND LEAKAGE WHEN ASKED OF COMPLICATIONS WHILE USING FOLEY CATHETER. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Hematuria; Pain; Urinary Tract Infection

  MAUDE report 14018307 ↗
• MalfunctionApr 5, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CUSTOMER MENTIONED ABOUT LEAKAGE WHEN ASKED ABOUT THE COMPLICATIONS FACED WHILE USING THE FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14018291 ↗
• InjuryApr 5, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE SURVEY RESPONDENT MENTIONED ABOUT BACTERIURIA, CATHETER BLOCKAGE AND LEAKAGE WHEN ASKED OF COMPLICATIONS WHILE USING FOLEY CATHETER. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR BACTERIURIA.

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

  MAUDE report 14018290 ↗
• MalfunctionDec 27, 2021Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON AREA WAS COMPLETELY FLAT AND SLIPPED OUT. THE FOLEY CATHETER WAS IN THE PATIENT LESS THEN 48 HOURS. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13087612 ↗
• MalfunctionDec 14, 2021Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON WAS FILLED WITH 10CC OF FLUID THEREAFTER CATHETER FELL OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13004356 ↗
• MalfunctionApr 6, 2018Burst Container or Vessel

  IT WAS REPORTED THAT THE BALLOON BURST INSIDE OF THE PATIENT, IMMEDIATELY AFTER INSERTION. IT WAS REPORTED THAT THERE WERE NO PIECES OF THE BALLOON MISSING.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7404372 ↗
• MalfunctionApr 6, 2018Burst Container or Vessel

  IT WAS REPORTED THAT THE BALLOON BURST INSIDE OF THE PATIENT IMMEDIATELY AFTER INSERTION. IT WAS ALSO REPORTED THAT THERE WERE NO PIECES OF THE BALLOON MISSING.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7402403 ↗
• MalfunctionApr 6, 2018Burst Container or Vessel

  IT WAS REPORTED THAT THE BALLOON BURST INSIDE OF THE PATIENT IMMEDIATELY AFTER INSERTION. IT WAS ALSO REPORTED THAT THERE WERE NO PIECES OF THE BALLOON MISSING.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7402336 ↗
• MalfunctionApr 4, 2018Failure to Infuse; Inflation Problem; Failure to Infuse

  IT WAS REPORTED THAT THE BALLOONS OF THE SILICONE FOLEY CATHETERS WERE DIFFICULT TO INFLATE; THERFORE, THE FOLEY CATHETERS WERE UNABLE TO BE USED.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 7397186 ↗