Bardex® Foley Catheter Silicone Coated 0167V16SRecalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00801741019203), received between Oct 1, 2024 and Sep 29, 2026 — classified as 2 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (22 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 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Material Rupture

  Patient problems: Pain

  MAUDE report 50940515 ↗
• MalfunctionSep 26, 2026Deflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50908453 ↗
• MalfunctionAug 14, 2026Material Puncture/Hole; Material Rupture

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

  MAUDE report 50256586 ↗
• MalfunctionAug 14, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50255252 ↗
• MalfunctionMay 28, 2026Inaccurate Flow Rate

  IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT A TRANSURETHRAL GREEN LIGHT ENUCLEATION OF THE PROSTATE PRESERVING THE 12 O CLOCK URETHRAL MUCOSA. THE SURGERY WAS SMOOTH, AND POSTOPERATIVE CATHETERIZATION WAS PERFORMED. AFTER INSERTION OF AN F18 THREE WAY FOLEY CATHETER, DRAINAGE WAS NOT SMOOTH, RESULTING IN POSTOPERATIVE URINARY RETENTION, BLADDER DISTENSION AND PAIN, CAUSING THE PATIENT SUFFERING AND SECONDARY INJURY.

  Patient problems: Abdominal Distention; Pain; Urinary Retention

  MAUDE report 25325530 ↗
• MalfunctionMay 1, 2026Material Rupture

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS IN PLACE FOR LESS THAN A DAY, AND THE BALLOON BROKE ON ITS OWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25056547 ↗
• MalfunctionApr 29, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE DEPARTMENT HAD REPORTED RECENT CASES OF CATHETER DRAINAGE PORT BLOCKAGES OR CONTAMINATION, PRIMARILY INVOLVING THE 123416C MODEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25037668 ↗
• MalfunctionApr 29, 2026Partial Blockage

  IT WAS REPORTED THAT THE FOLEY CATHETER DRAINAGE PORT OCCASIONALLY GETS BLOCKED OR CONTAINS IMPURITIES, MAINLY CONCENTRATED IN THE 123416C MODEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25037666 ↗
• MalfunctionApr 7, 2026Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CYSTOSCOPY UNDER GENERAL ANESTHESIA, AND A 16F THREE WAY FOLEY CATHETER WAS INDWELLED POSTOPERATIVELY AND THE WATER FILLED PART OF THE BLADDER RUPTURED SPONTANEOUSLY., CAUSING THE PATIENT DIFFICULTY URINATING, AND A NEW URINARY CATHETER WAS INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24810969 ↗
• MalfunctionMar 17, 2026Material Rupture

  IT WAS REPORTED THAT ON (B)(6) 2026, FOLLOWING TRANSURETHRAL BILATERAL URETEROSCOPIC LASER LITHOTRIPSY WITH STENT PLACEMENT, A URINARY CATHETER WAS LEFT IN PLACE AND AT APPROXIMATELY 18:30, THE CATHETER BALLOON RUPTURED RESULTING IN SPONTANEOUS DISLODGEMENT OF THE CATHETER; UPON EXAMINATION, THE CATHETER WAS FOUND INTACT WITH NO RESIDUAL MATERIAL, AND THE PATIENT WAS ADVISED TO INCREASE FLUID INTAKE AND WAS MONITORED FOR SPONTANEOUS URINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24621744 ↗
• MalfunctionJan 23, 2026Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LEFT KIDNEY STONE LASER LITHOTRIPSY AND STONE REMOVAL WITH A URETEROSCOPE VIA TRANSURETHRAL APPROACH UNDER GENERAL ANESTHESIA ON (B)(6) 2025, WITH A URETERAL FOLEY CATHETER PLACED DURING SURGERY. THE CATHETER WAS REMOVED ON (B)(6) 2026 AT 08:19 ACCORDING TO MEDICAL INSTRUCTIONS AND FOUND THAT THE URETER SAC BALLOON WAS FOUND TO BE LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24164917 ↗
• MalfunctionJan 21, 2026Material Puncture/Hole

  IT WAS REPORTED THAT AFTER FOLEY CATHETER PLACEMENT, THE BALLOON LEAKED AND THE URINARY CATHETER TO SLIP OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24138121 ↗
• MalfunctionJan 12, 2026Material Rupture

  IT WAS REPORTED THAT; THE PATIENT ENTERED THE OPERATING ROOM AT 09:00 ON (B)(6) 2025. UNDER GENERAL ANESTHESIA WITH A LARYNGEAL MASK AIRWAY IN PLACE, A TRANSURETHRAL LEFT URETEROSCOPY LASER LITHOTRIPSY AND STONE REMOVAL PROCEDURE WAS PERFORMED, FOLLOWED BY URETERAL STENT PLACEMENT. THE PATIENT RETURNED TO THE WARD AT 12:35. A DOUBLE-LUMEN NO. 14 URINARY CATHETER WAS PLACED INTRAOPERATIVELY AND SECURED FIRMLY FOR URINE DRAINAGE. ON (B)(6) 2025, AT 09:00, THE CATHETER WAS REMOVED AS ORDERED. PALE RED URINE WAS ASPIRATED FROM THE BALLOON DURING CATHETER EXTRACTION. THE CATHETER WAS SUBSEQUENTLY REMOVED, REVEALING A CLEAN-CUT RUPTURE OF THE BALLOON WITH NEAT EDGES. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Hematuria

  MAUDE report 24032134 ↗
• InjuryJan 12, 2026Complete Blockage

  IT WAS REPORTED THAT, THERE WAS A BLOCKAGE OF THE URINARY FOLEY CATHETER AND THERE WAS URINARY RETENTION IN THE BLADDER. INDWELLING CATHETERIZATION VIA CYSTOSTOMY WAS REINSERTED. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Urinary Retention

  MAUDE report 24032113 ↗
• MalfunctionDec 23, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT, THE PATIENT WAS ADMITTED TO THE GASTROENTEROLOGY DEPARTMENT ON (B)(6) 2025, PRESENTING WITH NAUSEA AND VOMITING FOR 2 DAYS. DUE TO CRITICAL CONDITION, THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT ON (B)(6) 2025. DIAGNOSIS 1. ACUTE BILIARY PANCREATITIS 2. GALLBLADDER STONES WITH ACUTE CHOLECYSTITIS. PER PHYSICIAN ORDERS, A SINGLE-USE STERILE URINARY FOLEY CATHETER WAS INDWELLING ON (B)(6) 2025, FOR URINARY DRAINAGE. THE OUTER PACKAGING WAS CAREFULLY INSPECTED FOR INTEGRITY PRIOR TO USE. HALF AN HOUR LATER, THE NURSE DISCOVERED THE IMPLANTED DISPOSABLE STERILE URINARY CATHETER HAD SLIPPED OUT. UPON IMMEDIATE INSPECTION, THE CATHETER'S BALLOON WAS FOUND RUPTURED. AFTER REPLACING THE DISPOSABLE STERILE URINARY CATHETER, THE ISSUE DID NOT RECUR. EXAMINATION REVEALED NO URETHRAL INJURY, AND URINARY DRAINAGE REMAINED NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23879671 ↗
• MalfunctionSep 29, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT, ON (B)(6) 2025, THE PATIENT REPORTED SUDDEN ONSET OF URINARY DIFFICULTY WITHOUT APPARENT CAUSE, PRESENTING AS FREQUENT URINATION, URGENCY, DELAYED VOIDING ONSET, AND STRAINING DURING URINATION. FOLLOWING MEDICAL ADVICE, CATHETERIZATION WAS PERFORMED. POST-CATHETERIZATION, IT WAS DISCOVERED THAT THE FLUSHING LUMEN OF THE THREE-LUMEN FOLEY CATHETER LACKED A STOPPER, RESULTING IN URINE LEAKAGE. THE CATHETER WAS REPLACED, CAUSING PAIN AND DISSATISFACTION FOR THE PATIENT. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Pain

  MAUDE report 23167109 ↗
• MalfunctionAug 28, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER PLACING A URINARY FOLEY CATHETER FOR THE PATIENT, NO OBVIOUS ABNORMALITIES WERE OBSERVED. DURING ROUNDS, URINE LEAKAGE FROM THE TUBING WAS DISCOVERED, WHICH DELAYED THE PATIENT'S TREATMENT AND POSED A RISK OF INFECTION. THE DOCTOR EXAMINED THE PATIENT AND RULED OUT THE RISK OF INFECTION, IMMEDIATELY REPLACED THE TUBING, AND REASSURED THE PATIENT AND FAMILY.

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

  MAUDE report 22913941 ↗
• MalfunctionJul 11, 2025Fracture; Fracture

  IT WAS REPORTED THAT WHEN THE PATIENT WAS RE-CATHETERIZED WITH A FOLEY CATHETER ON (B)(6) 2025, THE CATHETER WAS FOUND TO BE LEAKING, A CRACK WAS FOUND, AND THE CATHETER WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22481517 ↗
• MalfunctionJul 8, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT ON (B)(6) 2025, AT 11:30 A.M, A PATIENT WITH URINARY RETENTION WAS ADMITTED TO THE DEPARTMENT FOR TREATMENT. FOLLOWING MEDICAL INSTRUCTIONS, A DISPOSABLE STERILE URINARY FOLEY CATHETER WAS INSERTED INTO THE PATIENT. AFTER INSERTION, URINE FLOWED SMOOTHLY, AND THE PATIENT REPORTED NO PARTICULAR DISCOMFORT. THE PATIENT WAS GIVEN INSTRUCTIONS ON PRECAUTIONS TO TAKE. AT 6:00 P.M., AFTER THE PATIENT RETURNED HOME, THE URINARY CATHETER WAS FELL OUT. UPON INSPECTION, THE DISPOSABLE STERILE URINARY CATHETER'S WATER BAG WAS FOUND TO BE RUPTURED. IT WAS IMMEDIATELY REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22437053 ↗
• MalfunctionJun 27, 2025Material Rupture; Material Rupture

  IT WAS REPORTED ON (B)(6) 2025, A TRIPLE-LUMEN FOLEY CATHETER WAS INDWELLING FOR THE PATIENT. DURING URETHRAL CARE ON (B)(6) 2025 AT 06:30, THE CATHETER WAS FOUND TO HAVE BEEN DISLODGED, AND UPON EXAMINATION, IT WAS FOUND THAT THE CATHETER BALLOON HAD RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22346371 ↗
• MalfunctionJun 25, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH SYMPTOMS OF COUGHING, PHLEGM PRODUCTION, CHEST TIGHTNESS, AND SHORTNESS OF BREATH FOR THREE MONTHS, WORSENING OVER THE PAST FOUR DAYS. DIAGNOSIS WAS DONE AND FOUND THAT THERE WAS PULMONARY INFECTION AND ACUTE GASTRITIS. FOLLOWING THE DOCTOR'S INSTRUCTIONS, A DISPOSABLE STERILE URINARY FOLEY CATHETER WAS LEFT IN PLACE FOR URINARY DRAINAGE. AT 18:30 ON (B)(6) 2025, THE NURSE INSERTED A DISPOSABLE STERILE URINARY CATHETER INTO THE PATIENT AND INJECTED 15 ML OF SALINE SOLUTION. THE URINARY TUBE WAS UNOBSTRUCTED. AT 18:52, DURING A WARD ROUND, THE DISPOSABLE STERILE URINARY CATHETER CAME OUT ON ITS OWN. UPON INSPECTION, THE BALLOON OF THE DISPOSABLE STERILE URINARY CATHETER WAS FOUND TO BE DAMAGED. AFTER EXAMINATION, THE PATIENT WAS FOUND TO BE IN A SEDATED STATE, AND IT WAS RULED OUT THAT THE PATIENT HAD PULLED IT OUT THEMSELF. THE PATIENT'S URETHRA WAS UNDAMAGED. AFTER IMMEDIATE STANDARD DISINFECTION, THE DISPOSABLE STERILE URINARY CATHETER WAS REPLACED, AND CATHETERIZATION WAS NORMAL WITHOUT CAUSING ANY ADVERSE REACTIONS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22328907 ↗
• MalfunctionJun 24, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THE AFTER TRANSURETHRAL HOLMIUM LASER LITHOTRIPSY FOR RIGHT URETERAL STONES, INDWELLING CATHETERIZATION WAS PERFORMED, AND BLADDER IRRIGATION WAS PERFORMED TO PREVENT URINARY TRACT BLEEDING. THE PATIENT UNDERWENT CATHETERIZATION AFTER THE OPERATION. AIR LEAKAGE AT THE CATHETER WATER BAG CAUSED THE FOLEY CATHETER TO FELL OUT AUTOMATICALLY. THE PATIENT HAD NO SPECIAL PROBLEMS. CATHETER PROLAPSE MAKES IT IMPOSSIBLE FOR PATIENTS TO BETTER OBSERVE THE URINE COLOR AND VOLUME AFTER SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22322151 ↗
• MalfunctionJun 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT WHEN THE MEDICAL STAFF INTUBATED THE PATIENT, THEY FIRST TRIED TO INFLATE THE FOLEY CATHETER BALLOON. AFTER INFLATION, THE BALLOON SLOWLY DEFLATED WHICH INDICATED THAT THE CATHETER HAD AIR LEAKAGE AND BALLOON BURST. THE MEDICAL STAFF THEN REPLACED THE CATHETER AND SUCCESSFULLY INTUBATED THE PATIENT AFTER TESTING IT. HOSPITAL DEPARTMENT USE FEEDBACK RECENTLY CATHETER BALLOON RUPTURE FREQUENTLY. 2024 HAPPENED ONCE WAS INSERTED TUBING AFTER FILLING SALINE WHEN THE STORM BAG HAS VIDEO RECORDS, MAINLY CONCENTRATED IN THE 123416C AND 18C THESE TWO MODELS, THE HOSPITAL DEPARTMENT HAS BEEN USED FOR MANY YEARS, THERE WAS NO PROBLEM IN THE INSERTION OF THE TUBE OPERATION TECHNOLOGY, THE PROBLEM WAS STILL IN THE QUALITY OF PRODUCTS AS WELL AS THE PRODUCT FACTORY INSPECTION AND ACCEPTANCE. AND THERE WAS A DELAY IN SURGERY. MATERIAL#123416C AND MATERIAL#123418C.

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

  MAUDE report 22236632 ↗
• MalfunctionMay 29, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT ON 01APR2025, AFTER THE PATIENT'S LEFT URETEROSCOPY AND LASER LITHOTRIPSY, THE CONDITION REQUIRED THE PLACEMENT OF A URETHRAL FOLEY CATHETER. THE DOCTOR INSERTED A CATHETER FOR THE PATIENT, SECURED IT ACCORDING TO PROTOCOL, AND SUCCESSFULLY CONNECTED IT TO A DRAINAGE DEVICE. AFTER RETURNING TO THE WARD, THE PATIENT EXPERIENCED A RUPTURE OF THE CATHETER BALLOON. THE DOCTOR IMMEDIATELY ASSESSED THE PATIENT'S CONDITION AND FOUND NO EVIDENCE OF COMPLICATIONS SUCH AS URETHRAL INJURY. THE DOCTOR REPLACED THE CATHETER FOR THE PATIENT AND PERFORMED CATHETERIZATION AGAIN, WHILE ALSO KEEPING PROPER RECORDS AND ENSURING FOLLOW-UP OBSERVATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22105990 ↗
• MalfunctionMar 27, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE FOLEY CATHETER BURST AND CAUSED THE CATHETER TO SLIPPAGE. THE DEPARTMENT RESPONDED THAT THE CATHETER BALLOON RUPTURE AND SLIPPAGE INCIDENTS HAD OCCURRED FREQUENTLY RECENTLY, MAINLY CONCENTRATED IN THE 123416C MODEL. ON (B)(6), 2025, WHEN THE DEPARTMENT USED A DISPOSABLE STERILE CATHETER, WHEN GIVING THE PATIENT AN INDWELLING CATHETERIZATION OPERATION, WHEN CHECKING WHETHER THE BALLOON WAS INTACT, IT WAS FOUND TO BE DAMAGED, BUT THE PATIENT WAS IMMEDIATELY REPLACED WITH A NEW CATHETER, AND THE PROBLEM WAS REPORTED TO THE MEDICAL EQUIPMENT DEPARTMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21707846 ↗