Bardia® Foley Catheter Silicone Coated 123618ARecalls & reported problems

Summary

The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 00801741095207), received between Jun 13, 2018 and Sep 29, 2026 — classified as 10 injuries, 56 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (19 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 66 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50940520 ↗
• MalfunctionMar 30, 2026Inaccurate Flow Rate

  IT WAS REPORTED THAT, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR CEREBRAL INFARCTION AND OTHER CONDITIONS, ON (B)(6) 2026 THE PATIENT HAD A SINGLE-USE STERILE URINARY CATHETER, ON (B)(6) 2026 THE URINARY CATHETER WAS OBSERVED AND FOUND THAT THE URINE WAS NOT DRAINING FROM THE TUBING AND WAS LEAKING OUT OF THE URETHRAL ORIFICE, THE PATIENT WAS IMMEDIATELY REPORTED TO THE NURSE MANAGER, THE PHYSICIAN IN CHARGE, AND THE CONSUMABLE MANAGEMENT UNIT, AND THE URINARY CATHETER WAS REMOVED FROM THE PATIENT IN COMPLIANCE WITH THE MEDICAL ADVICE. THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24714506 ↗
• MalfunctionFeb 27, 2026Material Rupture

  IT WAS REPORTED THAT THE NURSING STUDENT HAD GONE INTO THE PATIENT¿S ROOM DURING THE FIRST ROUND. THE PATIENT HAD STATED THAT HE FELT HIS CATHETER WAS BYPASSING. THE STUDENT THEN FOUND THE CATHETER IN THE BED WITH THE BALLOON RUPTURED. A FOLEY CATHETER HAD BEEN INSERTED 4 DAYS PRIOR. ACCORDING TO AVATAR, A 10 ML BALLOON FILL HAD BEEN USED, WHICH WAS STANDARD.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24475117 ↗
• MalfunctionJan 30, 2026Material Rupture

  IT WAS REPORTED THAT ON (B)(6) 2025, AT 20:45, FOR PATIENT IN OBSTETRICS, BED 10, ADMISSION NUMBER (B)(4), DURING INDWELLING CATHETERIZATION, THE FOLEY CATHETER BALLOON RUPTURED DURING THE INFLATION PROCESS. THE DISPOSABLE STERILE CATHETER WAS IMMEDIATELY DISCONTINUED AND REPLACED WITH A NEW, QUALIFIED DISPOSABLE STERILE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24226744 ↗
• MalfunctionDec 3, 2025Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT DURING USE THE FOLEY CATHETER DRAINAGE LUMEN WAS DAMAGED AND LEAKED AT THE JOINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23708921 ↗
• MalfunctionNov 20, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT AT 10:00 AM ON (B)(6) 2025, DURING THE REINSERTION OF THE URINARY FOLEY CATHETER, IT WAS DISCOVERED THAT THE BALLOON HAD RUPTURED. THE CATHETER WAS IMMEDIATELY REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23608566 ↗
• InjuryNov 10, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT, THE PATIENT EXPERIENCED URINARY FOLEY CATHETER OBSTRUCTION. A NEW CATHETER WAS INSERTED USING A STERILE BARD 18F CATHETER. THE PLACEMENT WAS SUCCESSFUL. IN THE AFTERNOON, THE PATIENT REPORTED ABDOMINAL PAIN. AN ABDOMINAL CT SCAN REVEALED THE CATHETER BALLOON WAS OUTSIDE THE BLADDER. THE CATHETER WAS IMMEDIATELY REMOVED AND REINSERTED UNDER ULTRASOUND GUIDANCE. MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Abdominal Pain

  MAUDE report 23518901 ↗
• InjuryOct 27, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT, AFTER USING A URINARY CATHETER, THE PATIENT WAS UNABLE TO DISCHARGE URINE NORMALLY DUE TO BLOCKAGE, LEADING TO URINARY TRACT INFECTION. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Urinary Tract Infection

  MAUDE report 23390520 ↗
• MalfunctionOct 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT HAD A URINARY FOLEY CATHETER PLACED AFTER UROLOGICAL STONE LITHOTRIPSY TO DRAIN URINE AND MONITOR ITS COLOR AND VOLUME. ON (B)(6) 2025, AT 11:00, IT WAS DISCOVERED THAT THE BALLOON HAD RUPTURED AND THE CATHETER HAD COME OUT OF THE BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23328549 ↗
• MalfunctionOct 8, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT AFTER THE PATIENT UNDERWENT 'TRANSURETHRAL URETEROSCOPIC LASER LITHOTRIPSY AND TRANSURETHRAL URETERAL STENT PLACEMENT,' A URINARY FOLEY CATHETER WAS ROUTINELY LEFT IN PLACE TO DRAIN URINE. DURING THE MORNING ROUNDS, IT WAS OBSERVED THAT THE CATHETER HAD EXCESSIVELY SLIPPED OUT OF THE URETHRA. THE CATHETER WAS REMOVED, AND EXAMINATION REVEALED THAT THE CATHETER BALLOON HAD RUPTURED, CAUSING IT TO BE EXPELLED OUTSIDE THE BODY. THIS DID NOT CAUSE ANY HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23246267 ↗
• MalfunctionOct 8, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT, AFTER UNDERGOING TRANSURETHRAL URETEROSCOPIC HOLMIUM LASER LITHOTRIPSY FOR RENAL PELVIS/URETERAL STONES WITH URETERAL STENT PLACEMENT, THE PATIENT COMPLAINED OF LOWER ABDOMINAL DISTENSION AND PAIN DURING MORNING ROUNDS. PHYSICAL EXAMINATION REVEALED A PARTIALLY DISLOCATED URINARY FOLEY CATHETER. THE CATHETER WAS REMOVED, AND THE CATHETER BALLOON WAS FOUND TO BE RUPTURED. THIS DID NOT AFFECT THE PATIENT. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Abdominal Distention; Pain

  MAUDE report 23246070 ↗
• InjuryAug 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO OUR HOSPITAL DUE TO A FOLEY CATHETER-RELATED URINARY TRACT INFECTION. DURING THE PROCESS, THE CATHETER BALLOON RUPTURED, AND THE CATHETER ITSELF ALSO BROKE, MAKING IT UNUSABLE. A NEW CATHETER WAS IMMEDIATELY REPLACED, AND TREATMENT CONTINUED. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Urinary Tract Infection

  MAUDE report 22874145 ↗
• MalfunctionAug 21, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO OUR HOSPITAL DUE TO A FOLEY CATHETER-RELATED URINARY TRACT INFECTION. DURING THE PROCESS, THE CATHETER BALLOON RUPTURED, AND THE CATHETER ITSELF ALSO BROKE, MAKING IT UNUSABLE. A NEW CATHETER WAS IMMEDIATELY REPLACED, AND TREATMENT CONTINUED. THERE WAS NO IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22860650 ↗
• MalfunctionAug 21, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO OUR HOSPITAL DUE TO A FOLEY CATHETER-RELATED URINARY TRACT INFECTION. DURING THE PROCESS, THE CATHETER BALLOON RUPTURED, AND THE CATHETER ITSELF ALSO BROKE, MAKING IT UNUSABLE. A NEW CATHETER WAS IMMEDIATELY REPLACED, AND TREATMENT CONTINUED. THERE WAS NO IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22860649 ↗
• MalfunctionAug 19, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED DUE TO PROGRESSIVE NARROWING OF URINARY STREAM ACCOMPANIED BY RECURRENT DIFFICULTY IN URINATION FOR MORE THAN A YEAR. AFTER COMPLETING THE EXAMINATION, ON (B)(6) 2025, THE PATIENT UNDERWENT URETEROSCOPY, URETHRAL DILATION, AND FOLEY CATHETER PLACEMENT. IN THAT EVENING, THE PATIENT REPORTED THAT THE CATHETER HAD FALLEN OUT BY ITSELF. AFTER INFORMING THE DOCTOR, AN EXAMINATION REVEALED THAT THE CATHETER'S BALLOON HAD RUPTURED BY ITSELF, BUT THE EDGES OF THE RUPTURE WERE INTACT, AND IT WAS SUBSEQUENTLY REPLACED. NO HARM WAS CAUSED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22839524 ↗
• MalfunctionJun 30, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE ELECTRO RESECTION OF BLADDER LESIONS FROM (B)(6) 2025, POSTOPERATIVE INDWELLING FOLEY CATHETER, THE BALLOON RUPTURED SO THE CATHETER DISLODGED, AND REPOSITIONING OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22359394 ↗
• MalfunctionJun 4, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT PATIENT UNDERWENT HOLMIUM LASER LITHOTRIPSY ON (B)(6) 2025, POSTOPERATIVE URINARY CATHETER WAS LEFT IN PLACE AND WAS REPLACED ON (B)(6) 2025 AT 14:30 THE FOLEY CATHETER BALLOON RUPTURED CAUSED THE CATHETER TO DISLODGE ON ITS OWN AT 14:37 ADVERSE EVENTS IMPROVED. DELAYED TREATMENT

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

  MAUDE report 22141798 ↗
• MalfunctionMay 29, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT AFTER PLACEMENT OF THE FOLEY CATHETER FOR THE PATIENT, IT WAS FOUND THAT THE BALLOON COULD NOT BE INFLATED, SO THE CATHETER WAS REPLACED. IT DID NOT AFFECT THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22104725 ↗
• MalfunctionDec 24, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS NOT VERY SMOOTH WHEN USED ON PATIENTS, AND THE CATHETER WAS RELATIVELY DRY, CAUSING ADDITIONAL PAIN TO THE PATIENTS.

  Patient problems: Pain

  MAUDE report 21011296 ↗
• MalfunctionDec 13, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT ON (B)(6) 2019 AT 10:48 ON THE DAY, A URINARY FOLEY CATHETER WAS PLACED IN ACCORDANCE WITH THE DOCTOR ADVICE TO ASSIST URINATION. NURSE USED A 18FR URINARY CATHETER IMPORTED AND STRICTLY FOLLOWED THE OPERATING PROCEDURES. DURING THE PRE-INSPECTION OF THE CATHETER, IT WAS FOUND THAT THE WATER BAG WAS RUPTURED, AND IT WAS REPLACED IMMEDIATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20925861 ↗
• MalfunctionDec 6, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT GAVE BIRTH NATURALLY AND HAD HEAVY BLEEDING FOR 4 PLUS HOURS AFTER THE OPERATION. PATIENT UNDERWENT INTERVENTIONAL TREATMENT AND HAD AN INDWELLING FOLEY CATHETER ON (B)(6) 2024. ON THE FIRST DAY AFTER THE CATHETER WAS PLACED, LEAKAGE OCCURRED. AFTER THE CATHETER WAS REMOVED, IT WAS FOUND THAT THE FOLEY CATHETER BALLOON WAS LEAKING SIGNIFICANTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20864094 ↗
• MalfunctionNov 25, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT HAD A RIGHT URETERAL STONE WITH HYDRONEPHROSIS, WHICH WAS TREATED SURGICALLY WITH AN INDWELLING URINARY FOLEY CATHETER, WHICH WAS REMOVED ON THE FIRST POST OPERATIVE DAY AFTER SIGNIFICANT CATHETER BALLOON LEAKAGE WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20771807 ↗
• MalfunctionNov 25, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THE PATIENT HAD A RIGHT URETERAL STONE WITH HYDRONEPHROSIS, WHICH WAS TREATED SURGICALLY WITH AN INDWELLING URINARY FOLEY CATHETER, WHICH WAS REMOVED ON THE FIRST POST OPERATIVE DAY AFTER SIGNIFICANT CATHETER BALLOON LEAKAGE WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20771536 ↗
• MalfunctionNov 5, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO "RIGHT HIP INJURY AND PAIN CAUSED BY A FALL, ACCOMPANIED BY DIFFICULTY IN MOVEMENT FOR 1 DAY". THE DIAGNOSIS UPON ADMISSION: RIGHT INTERTROCHANTERIC FRACTURE. AT NOON ON (B)(6) 2024, THE PATIENT WAS UNABLE TO URINATE ON THEIR OWN, SO THEY WERE GIVEN AN INDWELLING CATHETER. 15 ML OF SALINE WAS INJECTED AS A FIXATIVE. THE OPERATION WENT SMOOTHLY, AND THE DRAINAGE OF URINE WAS UNOBSTRUCTED. THE PATIENT'S FAMILY DISCOVERED THAT THE FOLEY CATHETER HAD FALLEN OFF ON ITS OWN AT 18:40 ON (B)(6), SO THEY NOTIFIED THE NURSE ON DUTY, DISINFECTED THE EXTERNAL URETHRAL OPENING, AND CONDUCTED CLINICAL MEDICAL OBSERVATION. THIS INCIDENT DID NOT CAUSE ANY IMPACT ON THE PATIENT. THE DOCTOR AND NURSE ON DUTY EXAMINED THE FALLEN CATHETER AND FOUND THAT THE CATHETER WATER STORAGE BAG WAS RUPTURED. SINCE THE PATIENT COULD ALREADY URINATE ON HIS OWN, THERE WAS NO NEED TO RE-PLACE THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20609918 ↗
• MalfunctionOct 8, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT ON (B)(6) 2024, AT 10:00 A.M. THE PATIENT COMPLAINED OF CATHETER NONCOMPLIANCE WITH LOWER ABDOMINAL DISTENSION AND DISCOMFORT ON EXAMINATION, THE FOLEY CATHETER WAS SEEN TO BE SEMI-DISLODGED, AND SYRINGE SUCTION OF THE CATHETER BALLOON DID NOT SHOW ANY FLUID REFLUX AND REMOVAL OF THE CATHETER REVEALED A CATHETER BALLOON RUPTURED WITHOUT RESIDUAL DEFECTS. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Abdominal Distention; Discomfort

  MAUDE report 20396847 ↗