Bardia® Foley Catheter Silicone Coated 123616ARecalls & reported problems

Summary

The FDA's MAUDE database contains 126 adverse event reports that list this exact device (DI 00801741095191), received between May 2, 2017 and Jun 19, 2026 — classified as 19 injuries, 107 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (40 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 126 reports, in the reporter's own words as published by the FDA.

• InjuryJun 19, 2026Burst Container or Vessel; Material Rupture

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL AT 12:24 P.M. ON (B)(6) 2026 WITH "LEFT SIDED LOWER BACK AND ABDOMINAL PAIN FOR THREE DAYS," AND WAS DIAGNOSED WITH "BILATERAL HYDRONEPHROSIS WITH URETERAL STONES," AND UNDERWENT TRANSURETHRAL URETEROPELVIC PELVIC LASER LITHOTRIPSY FOR STONE REMOVAL (LEFT SIDE), TRANSURETHRAL URETEROSCOPIC HOLMIUM LASER LITHOTRIPSY FOR STONE REMOVAL (RIGHT SIDE), AND TRANSURETHRAL URETERAL STENT IMPLANTATION (BOTH SIDES) FROM 16:45 TO 17:40, WITH URETERS PLACED DURING THE OPERATION. AT 19:33 ON THE (B)(6), THE PATIENT COMPLAINED OF UNBEARABLE PAIN IN THE URETHRA, SO THE DOCTOR CONSIDERED THAT THE TUBING WAS THE CAUSE OF THE PAIN AND REMOVED THE URETHRA, WHICH WAS FOUND TO BE RUPTURED NEAR THE TIP OF THE URETHRA. THE PATIENT COMPLAINED OF PAIN RELIEF AFTER THE TUBING WAS REMOVED, AND THE SURGEON CLOSELY MONITORED THE PATIENT'S CONDITION.

  Patient problems: Pain

  MAUDE report 25566058 ↗
• InjuryJun 19, 2026Material Rupture

  It was reported that during the surgery, the foley catheter balloon broke, and a piece of it remained in the patient's bladder. At the start of the surgery, the surgeon placed a catheter as needed. Before catheterization, the balloon was tested and intact, and the catheter was inserted according to protocol, with 15ml of saline injected into the balloon. At 11:30, the catheter came out on its own, and upon inspection, the catheter balloon was found to be damaged with a missing piece around 1 0.5cm. The urology team was consulted during the surgery, and using a ureteroscope to examine the bladder, the missing piece was found and removed from the patient's bladder. Comparing the missing piece to the broken part, they matched completely. The patient has not experienced any other adverse effects so far.

  Patient problems: Foreign Body In Patient

  MAUDE report 25563770 ↗
• MalfunctionJun 17, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT WAS ADMITTED ON (B)(6) 2026, WITH LOWER ABDOMINAL PAIN AND DIFFICULTY URINATING FOR SEVEN DAYS AND WAS DIAGNOSED WITH RIGHT HYDRONEPHROSIS WITH URETERAL CALCULI. DURING THE PROCEDURE, A URETERAL CATHETER WAS PLACED TO ASSIST POSTOPERATIVE URINATION FOLLOWING TRANSURETHRAL HOLMIUM LASER URETERAL LITHOTRIPSY AND URETERAL INSERTION. ON (B)(6) 2026, THE PATIENT'S FAMILY REPORTED THAT THE URETERAL CATHETER HAD SLIPPED OUT. UPON EVALUATION AND CATHETER REMOVAL, THE PHYSICIAN OBSERVED THAT THE CATHETER BALLOON HAD RUPTURED. THE PATIENT WAS SUBSEQUENTLY PLACED UNDER CLOSE MEDICAL OBSERVATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25540991 ↗
• MalfunctionMar 19, 2026Material Rupture

  IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT LAPAROSCOPIC UNILATERAL NEPHROURETERECTOMY LEFT SIDE AND TRANSURETHRAL RESECTION OF BLADDER LESIONS UNDER GENERAL ANESTHESIA. AFTER THE SURGERY, THE PATIENT RETURNED TO THE WARD WITH AN INDWELLING CATHETER. AT 21:25 ON (B)(6) 2026, THE CALL BELL RANG, AND THE DOCTOR WENT TO THE BEDSIDE TO CHECK. THE PATIENT REPORTED URINE LEAKAGE FROM THE URETHRA, AND EXAMINATION REVEALED PARTIAL DISLODGEMENT OF THE CATHETER. THE DOCTOR IMMEDIATELY REPORTED THIS TO THE ATTENDING PHYSICIAN. AFTER EXAMINING THE PATIENT AT THE BEDSIDE, THE ATTENDING PHYSICIAN, REMOVED THE INDWELLING CATHETER, REVEALING THAT THE BALLOON AT THE TIP WAS RUPTURED, WHILE THE REST REMAINED INTACT. AT 21:30, THE ATTENDING PHYSICIAN REINSERTED THE CATHETER SMOOTHLY, AND PALE-YELLOW URINE DRAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24644066 ↗
• InjuryMar 13, 2026Difficult to Remove

  IT WAS REPORTED THAT, ON (B)(6) 2026, AT 12:20 PM, THE PATIENT UNDERWENT VAGINAL ANTERIOR AND POSTERIOR WALL REPAIR, REPAIR OF AN OLD PERINEAL LACERATION, AND URETHRAL SUSPENSION UNDER GENERAL ANESTHESIA AT (B)(6) HOSPITAL. DURING THE PROCEDURE, THE PHYSICIAN PLACED A 16-GAUGE URINARY FOLEY CATHETER ACCORDING TO STANDARD OPERATING PROCEDURES AND INFLATED THE BALLOON WITH 10 ML OF SALINE SOLUTION. THE CATHETER PLACEMENT WAS COMPLETED WITHOUT INCIDENT. ON (B)(6) 2026, AT 9:35 AM, DURING CATHETER REMOVAL IN THE WARD, THE BALLOON FLUID COULD NOT BE COMPLETELY DRAINED, PREVENTING CATHETER EXTRACTION. SUBSEQUENT ACTIONS INCLUDED: REQUESTING CONSULTATION FROM UROLOGY AND ULTRASOUND DEPARTMENTS; CUTTING THE CATHETER IN HALF; PREPARING FOR TRANSURETHRAL BLADDER FOREIGN BODY REMOVAL UNDER GENERAL ANESTHESIA AFTER ALL ATTEMPTS FAILED. THE CATHETER SPONTANEOUSLY DISLODGED AROUND 15:30. THIS INCIDENT CAUSED SIGNIFICANT PSYCHOLOGICAL DISTRESS AND TRAUMA TO THE PATIENT, WHO WAS SUBSEQUENTLY COMFORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Distress; Insufficient Information

  MAUDE report 24595117 ↗
• MalfunctionJan 2, 2026Material Puncture/Hole

  IT WAS REPORTED THAT ON (B)(6), THE PATIENT UNDERWENT INDWELLING CATHETERIZATION DUE TO URINARY RETENTION. ON (B)(6), THE CATHETER DISLODGED DUE TO A LEAKING BALLOON. A NEW STERILE CATHETER WAS SUBSEQUENTLY REPLACED AND REINSERTED TO COMPLETE CATHETERIZATION. THIS INCIDENT DID NOT AFFECT THE PATIENT'S TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23952368 ↗
• MalfunctionDec 19, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT ON (B)(6) 2025, IN THE AFTERNOON, THE PATIENT IN BED 35 UNDERWENT BLADDER HEMATOMA REMOVAL SURGERY. AFTER THE OPERATION, AN 18-FRENCH THREE-WAY FOLEY CATHETER WAS INDWELLED FOR CONTINUOUS BLADDER IRRIGATION. ABOUT 2 HOURS POSTOPERATIVELY, THE PATIENT SUDDENLY FELT AN EXPLOSIVE SENSATION IN THE LOWER ABDOMEN, AFTER WHICH THE CATHETER WAS SPONTANEOUSLY EXPELLED. UPON EXAMINATION, THE DOCTOR FOUND THAT THE CATHETER BALLOON HAD RUPTURED, AND THE CATHETER WAS SUBSEQUENTLY REINSERTED. THE BALLOON RUPTURE OCCURRED IMMEDIATELY AFTER THE BLADDER HEMATOMA REMOVAL SURGERY, AND THE REINSERTION OF THE CATHETER CAUSED HARM TO THE PATIENT.

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

  MAUDE report 23856332 ↗
• MalfunctionDec 19, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT, AFTER THE PATIENT'S URINARY FOLEY CATHETER DISLODGED, IT WAS DISCOVERED THAT THE CATHETER BALLOON HAD RUPTURED, RAISING CONCERNS ABOUT POTENTIAL QUALITY ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23856325 ↗
• MalfunctionDec 11, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT AROUND 12:00 ON (B)(6) 2025, THE PATIENT IN BED 13 OF THE DEPARTMENT UNDERWENT TRANSURETHRAL URETER/RENAL PELVIS LASER LITHOTRIPSY AND STONE REMOVAL AND RIGHT URETERAL STENT REMOVAL. AFTER SURGERY, A FOLEY CATHETER WAS LEFT IN PLACE. AT 22:00 ON (B)(6) 2025, THE CATHETER FELL OUT, AND EXAMINATION REVEALED THAT THE CATHETER BALLOON HAD RUPTURED. THE PATIENT THEN HAD A NEW CATHETER INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23779614 ↗
• MalfunctionNov 25, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT ON (B)(6) 2025; WHILE PREPARING TO CATHETERIZE A PATIENT, A LEAK WAS DETECTED IN THE FOLEY CATHETER BALLOON. THE CATHETER WAS PROMPTLY REPLACED, AND NO HARM WAS CAUSED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23646702 ↗
• MalfunctionNov 14, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT ON (B)(6) 2025, IN THE EMERGENCY INTERNAL MEDICINE WARD, AT 13:18, A URINARY FOLEY CATHETER WAS INSERTED, AND SALINE WAS INSTILLED AS PER DOCTOR'S ORDERS, AND IT WAS FUNCTIONING NORMALLY. AT 15:30, DURING A ROUTINE WARD CHECK, THE NURSE FOUND THAT THE CATHETER HAD COME OFF AND OBSERVED THAT THE BALLOON WAS RUPTURED, WITH THE TEAR EXTENDING FROM TOP TO BOTTOM ACROSS THE ENTIRE BALLOON. WHEN ASKED WHETHER THE PATIENT HAD PULLED ON IT, THE PATIENT DENIED DOING SO. THE ON-DUTY NURSE WAS IMMEDIATELY NOTIFIED TO REPLACE THE CATHETER WITH A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23556495 ↗
• MalfunctionNov 12, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT, THE PATIENT WAS ADMITTED TO THE HOSPITAL ON A NON-EMERGENCY WALK AT (B)(6) 2025, DIAGNOSED WITH RIGHT URETERAL STONES WITH HYDRO STASIS AND INFECTION, AND SENT TO THE OPERATING ROOM AT (B)(6) 2025 FOR RIGHT RETROGRADE INTRARENAL SURGERY URETHRAL MASS BIOPSY UNDER GENERAL ANESTHESIA. AFTER THE OPERATION, REPORTED TO THE HEAD NURSE THAT WHEN THE PATIENT FINISHED THE OPERATION AT 10:20 AND WAS ABOUT TO PLACE A URINARY FOLEY CATHETER FOR THE PATIENT, IT WAS FOUND THAT THE CATHETER WAS FILLED WITH A MISSING CONICAL VALVE AFTER OPENING, RENDERING THE CATHETER UNUSABLE. THEREFORE, THE CATHETER WAS REPLACED. THIS DID NOT AFFECT THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23533804 ↗
• MalfunctionNov 11, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT ON (B)(6) 2025 THE PATIENT HAD AN INDWELLING FOLEY CATHETER, BUT THE CATHETER WATER-FILLED BALLOON LEAKED, CAUSING THE CATHETER TO SLIP OUT. THE CATHETER WAS REMOVED, AND A NEW ONE WAS REINSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23526490 ↗
• MalfunctionNov 4, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT UN THE MORNING OF (B)(6) 2025, PATIENT IN BED 38 COMPLAINED OF AN INABILITY TO URINATE. THE DOCTOR PERFORMED A RETAINED CATHETERIZATION. AFTER THE PROCEDURE, THE FOLEY CATHETER DISLODGED ON ITS OWN, AND AN EXAMINATION REVEALED THAT THE BALLOON WAS LEAKING AIR. THE CATHETER WAS IMMEDIATELY REPLACED, WITHOUT AFFECTING THE PATIENT'S TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23466440 ↗
• MalfunctionOct 31, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT TRANSURETHRAL RIGHT URETEROSCOPY WITH STENT PLACEMENT FOR RIGHT RENAL CALCULI COMPLICATED BY HYDRONEPHROSIS AND INFECTION. THE PROCEDURE COMMENCED AT 11:07 AND CONCLUDED AT 14:09, WITH THE PATIENT RETURNING TO THE WARD WITH THE CATHETER IN PLACE. AT 14:52, THE PATIENT REPORTED URETHRAL ORIFICE PAIN AND URINARY LEAKAGE. NURSING ASSESSMENT REVEALED NO SIGNIFICANT DISPLACEMENT OF THE EXTERNAL CATHETER SEGMENT, WITH REDUCED URINE VOLUME IN THE COLLECTION BAG. GENTLE TRACTION OF THE CATHETER CONFIRMED BALLOON RUPTURE. THE URETHRAL ORIFICE MUCOSA APPEARED ERYTHEMATOUS WITH MINOR BLEEDING, INDICATING POTENTIAL INFECTION RISK. SUBSEQUENTLY, THE PATIENT RESUMED SPONTANEOUS URINATION WITHOUT REQUIRING RE-CATHETERIZATION. NO LUBRICANT WAS USED. THIS REPRESENTS AN ISOLATED INCIDENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain; Skin Discoloration

  MAUDE report 23441360 ↗
• MalfunctionSep 30, 2025Material Fragmentation; Material Rupture; Material Fragmentation; Material Rupture

  IT WAS REPORTED THAT, FOUR HOURS AFTER THE NURSE INSERTED THE URINARY FOLEY CATHETER, THE PATIENT REPORTED DISCOMFORT, AND THE CATHETER DISLODGED, CAUSING URINE LEAKAGE. MEDICAL STAFF OBSERVED REDNESS AND SWELLING IN THE PATIENT'S VAGINAL AREA, ALONG WITH A RUPTURED CATHETER. MEDICAL STAFF IMMEDIATELY DISINFECTED THE AFFECTED AREA WITH POVIDONE-IODINE AND INSTRUCTED THE PATIENT'S FAMILY TO CHANGE INTO CLEAN CLOTHING. AFTER HALF AN HOUR OF OBSERVATION, THE PATIENT'S SYMPTOMS IMPROVED, AND NO ADVERSE EVENTS WERE NOTED. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Skin Discoloration; Swelling/ Edema

  MAUDE report 23183327 ↗
• MalfunctionSep 23, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT, THE PATIENT UNDERWENT ROUTINE URINARY CATHETERIZATION FOLLOWING CERVICAL CANCER SURGERY. ON THE FIRST POSTOPERATIVE DAY AT NOON, DURING VAGINAL CLEANSING, THE NURSE DISCOVERED THE BALLOON OF THE FOLEY CATHETER HAD DETACHED. EXAMINATION REVEALED A 3CM TEAR IN THE BALLOON. THE INCIDENT WAS IMMEDIATELY REPORTED TO THE ATTENDING PHYSICIAN, AND THE CATHETER WAS REPLACED WITH A DISPOSABLE ONE. THE PATIENT EXPERIENCED NO ADVERSE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23123092 ↗
• MalfunctionSep 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT, THE PATIENT, WHO HAD UNDERGONE LUMBAR SPINE SURGERY, COMPLAINED OF DYSURIA AND WAS TEMPORARILY CATHETERIZED BY FOLEY CATHETER. URINE LEAKED FROM THE URETHRA AFTER CATHETERIZATION. THIS DISCOVERY WAS REPORTED BY THE FAMILY, WHO INFORMED THE DOCTOR AND CONSULTED WITH THE UROLOGY DEPARTMENT. THE CATHETER WAS THEN REMOVED AND DISCONTINUED. THIS DID NOT AFFECT THE PATIENT'S TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23072509 ↗
• MalfunctionSep 16, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING THE WARD INSPECTION ON 01SEP2025, IT WAS FOUND THAT THE PATIENT'S DOUBLE FOLEY CATHETER HAD BROKEN AT THE BIFURCATION. THE ON-DUTY DOCTOR WAS IMMEDIATELY NOTIFIED, AND THE CATHETER WAS REINSERTED IN ACCORDANCE WITH MEDICAL INSTRUCTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23065188 ↗
• MalfunctionSep 5, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT, FEMALE PATIENT UNDERWENT RIGHT RENAL STONE REMOVAL VIA URETEROSCOPIC HOLMIUM LASER LITHOTRIPSY UNDER SPINAL ANESTHESIA ON (B)(6) 2025. THE INDWELLING URINARY FOLEY CATHETER REMAINED IN THE PATIENT. ON (B)(6) 2025, THE INDWELLING FOLEY CATHETER SPONTANEOUSLY DISLODGED. UPON EXAMINATION, THE CATHETER BALLOON WAS FOUND RUPTURED. THE PATIENT WAS INSTRUCTED TO INCREASE FLUID INTAKE AND ATTEMPT SPONTANEOUS URINATION. THE DISLODGED CATHETER WAS DISPOSED OF AS MEDICAL WASTE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22978862 ↗
• MalfunctionAug 13, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT ON (B)(6) 2025, WHEN THE PATIENT USED A DISPOSABLE STERILE URINARY FOLEY CATHETER, THE BALLOON LEAKED WATER, AND A NEW DISPOSABLE STERILE URINARY CATHETER WAS IMMEDIATELY REPLACED. NO HARM WAS CAUSED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22793985 ↗
• MalfunctionAug 4, 2025Material Rupture; Material Rupture

  THE DAY AFTER THE PATIENT'S SURGERY, THE URETERAL BALLOON SUDDENLY EXPLODED AND THE CATHETER SLIPPED OUT OF THE BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22708423 ↗
• InjuryJul 3, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT PATIENT WAS ADMITTED TO THE EMERGENCY DEPARTMENT DUE TO AN INABILITY TO URINATE FOR 12 HOURS. URINARY RETENTION WAS SUSPECTED, AND A URINARY FOLEY CATHETER WAS INSERTED. THE PATIENT REPORTED PAIN IN THE URETHRA ACCOMPANIED BY A SOUR, DISTENDED DISCOMFORT. PROVIDED SYMPTOMATIC TREATMENT SUCH AS ANALGESIA.

  Patient problems: Discomfort; Pain; Skin Inflammation/ Irritation

  MAUDE report 22394817 ↗
• MalfunctionJun 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2025 DUE TO SCROTAL SWELLING AND FEVER FOR 3 DAYS. AFTER ADMISSION, THEY DEVELOPED URINARY RETENTION AND HAD A URINARY FOLEY CATHETER WAS PLACED ON THE SAME DAY. DURING THE MORNING ROUNDS ON (B)(6), IT WAS FOUND THAT THE DRAINAGE OF THE URINARY CATHETER WAS NOT SMOOTH, AND THE PHYSICAL EXAMINATION FOUND THAT THE URINARY CATHETER HAD FALLEN OFF. THE URINARY CATHETER WAS REPLACED, AND NO HARM WAS CAUSED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22366677 ↗
• MalfunctionJun 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT URETERAL STONE LITHOTRIPSY ON (B)(6) 2025. AFTER THE SURGERY, A URINARY FOLEY CATHETER WAS LEFT IN PLACE TO OBSERVE THE COLOR AND QUANTITY OF URINE. THE CATHETER FELL OUT ON ITS OWN AT 12:10 PM ON (B)(6) 2025 AND UPON EXAMINATION, IT WAS FOUND THAT THE BALLOON HAD RUPTURED. AFTER REVIEW BY THE DEPARTMENT HEAD, IT WAS ADVISED TO CONTINUE MONITORING THE PATIENT CONDITION, AND THERE WAS NO ADVERSE EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22236619 ↗