Bardex Foley Catheter Silicone CoatedRecalls & reported problems across all models

We found 5 models of Bardex Foley Catheter Silicone Coated by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 532 adverse event reports in the FDA's MAUDE database, received between May 4, 2018 and Sep 29, 2026 — classified as 23 injuries, 509 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (238 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Bardex Foley Catheter Silicone Coated problems

Bardex Foley Catheter Silicone Coated models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Bardex® Foley Catheter Silicone Coated 0167V22S

  CATHETER, UROLOGICAL
  187 reports
• Bardex® Foley Catheter Silicone Coated 0167V20S

  CATHETER, UROLOGICAL
  175 reports
• Bardex® Foley Catheter Silicone Coated 0167V18S

  CATHETER, UROLOGICAL
  116 reports
• Bardex® Foley Catheter Silicone Coated 0167V16S

  CATHETER, UROLOGICAL
  37 reports
• Bardex® Foley Catheter Silicone Coated 0167V24S

  CATHETER, UROLOGICAL
  17 reports

Recent Bardex Foley Catheter Silicone Coated adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Material Rupture

  Patient problems: Pain

  MAUDE report 50940515 ↗
• MalfunctionSep 28, 2026Material Rupture

  It was reported that while making rounds in the ward, they noticed that the patient¿s pelvic drainage output had decreased compared to previous readings. Upon examining the drainage tubing balloon, they found that no sterile water was drawn back when they aspirated the balloon. When they gently pulled on the pelvic drainage tubing, it came out on its own, and the balloon was found to be ruptured vertically. they reported this to the on-call physician, who assessed the patient¿s condition and decided not to reinsert the tubing, instructing instead that the patient be kept under observation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924427 ↗
• MalfunctionSep 28, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923629 ↗
• MalfunctionSep 28, 2026Material Rupture

  It was reported that On September 11, the patient underwent a partial transurethral plasmakinetic resection of the prostate under general anesthesia due to prostatic hyperplasia. Postoperatively, an indwelling urinary catheter was maintained with continuous bladder irrigation to facilitate urine drainage and prevent catheter obstruction caused by blood clots. During the morning handover on September 12 (postoperative day 1), the catheter was found to have dislodged. Upon inspection, the retention balloon was observed to be ruptured; the on-duty physician was immediately notified. Following the dislodgement, the patient was unable to void spontaneously and complained of lower abdominal distension and discomfort; a urinary catheter was subsequently reinserted at the bedside, draining pale red urine. Explanations and reassurance were provided to the patient and their family, and relevant precautions were outlined; the family expressed their understanding.

  Patient problems: Abdominal Distention; Discomfort; Hematuria

  MAUDE report 50916292 ↗
• MalfunctionSep 26, 2026Deflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50908460 ↗
• MalfunctionSep 26, 2026Complete Blockage

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50908454 ↗
• MalfunctionSep 26, 2026Deflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50908453 ↗
• MalfunctionSep 26, 2026Complete Blockage

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50908451 ↗
• MalfunctionSep 25, 2026Complete Blockage

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50904193 ↗
• MalfunctionSep 25, 2026Material Rupture

  It was reported that following a transurethral holmium laser enucleation of the prostate (HoLEP) on (b)(6), a three way urinary foley catheter was indwelling. On (b)(6), during a patient repositioning maneuver, a "pop" sound was heard from the lower abdomen, and the catheter was immediately expelled along with the urine; inspection revealed a ruptured balloon, and a subsequent check confirmed the balloon's integrity with no residual fragments.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899377 ↗
• 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, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889828 ↗
• MalfunctionSep 24, 2026Inaccurate Flow Rate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889803 ↗

Other C. R. Bard, Inc. products

• Bardex I.C. Foley Catheter26 models · 3,607 reports
• Bardex Lubricath Foley Catheter38 models · 1,670 reports · 1 recall
• Bardex Lubri-Sil I.C. All-Silicone Foley Catheter26 models · 1,518 reports
• Magic3 Coude Intermittent Catheter with Sure-Grip Sleeve5 models · 1,466 reports
• Magic3 Intermittent Catheter with Sure-Grip Sleeve14 models · 1,310 reports
• Bardia Foley Catheter Silicone Coated19 models · 1,283 reports
• PureWick Female External Catheter5 models · 1,184 reports
• Bardex All-Silicone Foley Catheter12 models · 1,170 reports