Bardex® Foley Catheter Silicone Coated 0167V22SRecalls & reported problems

Summary

The FDA's MAUDE database contains 187 adverse event reports that list this exact device (DI 00801741019234), received between Sep 28, 2021 and Sep 28, 2026 — classified as 9 injuries, 178 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (77 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 187 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923629 ↗
• MalfunctionSep 26, 2026Complete Blockage

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50908451 ↗
• MalfunctionSep 25, 2026Material Rupture

  It was reported that when catheterized the patient, the Foley catheter balloon ruptured.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899376 ↗
• InjurySep 25, 2026Material Rupture

  It was reported that following transurethral resection of a bladder tumor, a balloon catheter was left in place to facilitate continuous bladder irrigation. During treatment, it was observed that the continuous bladder irrigation drainage was obstructed, and the irrigation fluid could not drain out smoothly. The medical team immediately conducted a bedside examination and confirmed that the catheter had dislodged and the balloon at its tip had ruptured. The faulty catheter was promptly removed, the patient¿s urethra and bladder were assessed, a new catheter was inserted, and continuous bladder irrigation was resumed. The patient was closely monitored for urine color, bleeding volume, urethral injury, and worsening hematuria. Subsequently, the patient¿s condition remained relatively stable, with no serious complications such as massive bleeding or urethral laceration. However, this incident prolonged the duration of the surgical procedure and increased the duration of anesthesia. Furthermore, fragments from the ruptured balloon posed a risk of remaining in the bladder as foreign bodies, potentially leading to secondary infection.

  Patient problems: Hematuria

  MAUDE report 50899375 ↗
• MalfunctionSep 25, 2026Inability to Irrigate

  It was reported that the patient was admitted for prostatic hyperplasia. On September 17 at 08:10, a transurethral partial prostatectomy combined with "Great White Shark" tissue morcellation was performed under combined spinal-epidural anesthesia. A three way urinary foley catheter was inserted intraoperatively. Upon returning to the ward at 11:00, bladder irrigation was initiated; however, significant resistance was encountered. Attempts to flush the catheter using a syringe filled with water met with similar resistance, indicating poor inflow. This situation posed a risk of urinary retention. Consequently, the catheter was removed and replaced with a new three way catheter from the same batch, resulting in unobstructed drainage.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895129 ↗
• MalfunctionSep 24, 2026Inaccurate Flow Rate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889803 ↗
• MalfunctionSep 24, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889802 ↗
• MalfunctionSep 24, 2026Complete Blockage

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889065 ↗
• MalfunctionSep 15, 2026Inflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50781544 ↗
• MalfunctionSep 15, 2026Difficult to Remove

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50781541 ↗
• MalfunctionSep 15, 2026Inability to Irrigate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50781540 ↗
• MalfunctionSep 6, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50639394 ↗
• MalfunctionSep 6, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50636923 ↗
• MalfunctionSep 5, 2026Incorrect Measurement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50634114 ↗
• MalfunctionSep 4, 2026Difficult to Remove

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50614130 ↗
• MalfunctionAug 18, 2026Complete Blockage

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50311083 ↗
• MalfunctionAug 14, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50256582 ↗
• MalfunctionAug 7, 2026Inflation Problem

  It was reported that the patient underwent a transurethral resection of the prostate at our hospital on (b)(6) 2026, at 11:25. At the end of the surgery, the nurse followed the doctor's instructions to insert a Foley catheter. When the nurse tried to inflate the catheter balloon with a syringe after inserting it, she found that it wouldn't inflate. The catheter was immediately replaced, and the catheterization was successfully completed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50181187 ↗
• MalfunctionAug 6, 2026Material Puncture/Hole

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

  MAUDE report 50156413 ↗
• MalfunctionAug 4, 2026Complete Blockage

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50130665 ↗
• MalfunctionJul 31, 2026Material Rupture

  It was reported that the patient had a Foley catheter after surgery on (b)(6) 2026. During a night round on (b)(6) 2026, the nurse found that the catheter had come out indicating that the balloon had ruptured.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50105793 ↗
• MalfunctionJul 20, 2026Material Invagination

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25884225 ↗
• MalfunctionJul 19, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25867758 ↗
• MalfunctionJul 14, 2026Material Puncture/Hole

  It was reported that the patient underwent a hysteroscopic examination, intrauterine adhesion lysis and intrauterine Foley catheter balloon placement at our hospital on (b)(6) 2026 due to 'intrauterine adhesions 1 week after abortion. After adhesion lysis, 'Gong Ankang' (medical sodium hyaluronate) was injected, and a uterine balloon was placed to prevent adhesions. When filling it, a leak was found, so a new sterile disposable catheter was used. After finishing the 'Gong Ankang' injection, the uterine balloon was placed again to prevent adhesions.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25816395 ↗
• MalfunctionJun 18, 2026Material Rupture; Use of Device Problem

  IT WAS REPORTED THAT PATIENT WAS ADMITTED ON (B)(6) 2026 DUE TO FREQUENT URINATION, URGENCY, AND INCREASED NIGHT TIME URINATION FOR 10 YEARS. ON THE AFTERNOON OF (B)(6) 2026 AT 2:30, UNDERWENT TRANSURETHRAL MICROWAVE RESECTION OF THE PROSTATE AND LASER LITHOTRIPSY OF BLADDER STONES. THE SURGERY WENT SMOOTHLY AND WAS SAFELY RETURNED TO THE WARD AFTERWARDS. THE PATIENT ACCIDENTALLY PULLED ON THE FOLEY CATHETER REPEATEDLY, CAUSING INCREASED PRESSURE, BALLOON RUPTURE, AND CATHETER REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25552930 ↗