Bard® Fluoro-4™ Silicone Ureteral Stent 233626Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10801741011686), received between May 10, 2017 and Aug 15, 2022 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 15, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE DOUBLE J URETERAL STENT WAS BROKEN INSIDE THE PATIENT¿S URETER DURING USE. AND STATED THAT THE PATIENT WAS SAFE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15225756 ↗
• MalfunctionJul 29, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE STENT WAS BROKEN IN THE PATIENT DURING THE USE AND THE PATIENT WAS SAFE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15135717 ↗
• MalfunctionApr 8, 2022Calcified; Calcified

  IT WAS REPORTED THAT THE USER EXPERIENCED URGENCY, DYSURIA, FLANK PAIN, SUPRAPUBIC PAIN, INCONTINENCE, HEMATURIA, URINARY TRACT INFECTION, IRRITATIVE URINARY SYMPTOMS AND STENT ENCRUSTATION WHILE USING THE URETERAL STENT. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14052621 ↗
• InjuryApr 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE USER EXPERIENCED URGENCY, DYSURIA, FLANK PAIN, SUPRAPUBIC PAIN, INCONTINENCE, HEMATURIA, URINARY TRACT INFECTION, IRRITATIVE URINARY SYMPTOMS AND STENT ENCRUSTATION WHILE USING URETERAL STENT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR THE URGENCY, DYSURIA, FLANK PAIN, SUPRAPUBIC PAIN, INCONTINENCE, HEMATURIA, URINARY TRACT INFECTION AND IRRITATIVE URINARY SYMPTOMS.

  Patient problems: Hematuria; Unspecified Kidney or Urinary Problem; Urinary Tract Infection

  MAUDE report 14021951 ↗
• MalfunctionJul 9, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE FRONT TIP OF THE STENT WAS FOUND BROKEN. CUSTOMER USED ANOTHER NEW D-J.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12142484 ↗
• MalfunctionJun 22, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE FRONT TIP OF THE STENT WAS FOUND TO BE BROKEN. THEY STATED THAT ANOTHER NEW D-J WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12045824 ↗
• MalfunctionJul 22, 2019Break; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE STENT COULD NOT BE PLACED SMOOTHLY, THE END TIP OF THE DEVICE WAS SUSPECTED TO BE BROKEN.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8812999 ↗
• MalfunctionAug 8, 2017Break; Split

  IT WAS REPORTED THAT THE PIGTAIL WAS SPLIT/BROKEN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6775761 ↗
• MalfunctionMay 10, 2017Break

  IT WAS REPORTED THAT THERE WAS A SPLIT IN THE DEVICE.

  Patient problems: No Patient Involvement

  MAUDE report 6556848 ↗