Bard Fluoro-4 Silicone Ureteral StentRecalls & reported problems across all models
C. R. Bard, Inc. · 5 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 32
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 0
We found 5 models of Bard Fluoro-4 Silicone Ureteral Stent by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 32 adverse event reports in the FDA's MAUDE database, received between May 10, 2017 and Aug 15, 2022 — classified as 3 injuries, 29 malfunctions.
The most frequently reported specific device problem is “Break” (12 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 Bard Fluoro-4 Silicone Ureteral Stent problems
Device problems
- Break12
- Material Fragmentation6
- Adverse Event Without Identified Device or Use Problem3
- Calcified3
- Device Dislodged or Dislocated3
- Migration2
- Activation, Positioning or Separation Problem1
- Component Missing1
Patient problems
- No Clinical Signs, Symptoms or Conditions16
- No Known Impact Or Consequence To Patient8
- No Patient Involvement5
- Hematuria2
- No Information2
- Urinary Tract Infection2
- Micturition Urgency1
- No Consequences Or Impact To Patient1
Bard Fluoro-4 Silicone Ureteral Stent models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Bard® Fluoro-4™ Silicone Ureteral Stent 233624STENT, URETERAL13 reports
- Bard® Fluoro-4™ Silicone Ureteral Stent 233626STENT, URETERAL9 reports
- Bard® Fluoro-4™ Silicone Ureteral Stent 233724STENT, URETERAL5 reports
- Bard® Fluoro-4™ Silicone Ureteral Stent 233726STENT, URETERAL4 reports
- Bard® Fluoro-4™ Silicone Ureteral Stent 233622STENT, URETERAL1 report
Recent Bard Fluoro-4 Silicone Ureteral Stent adverse event reports
The 15 most recent reports across all models, 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 22, 2022Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT WHEN DOCTOR WANTS TO DISASSEMBLE THE STENT, IT WAS FOUND THAT THE D-J WAS BROKEN. IT WAS STATED THAT THEY REPLACED IT WITH A NEW ONE TO CONTINUE THE OPERATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14189809 ↗MalfunctionApr 8, 2022Illegible Information; Illegible Information
IT WAS REPORTED THAT CUSTOMER STATED THAT THE STENT HAD ENCRUSTATION. ALSO, THE PATIENT HAD SURGICAL SITE INFECTION AND STENT DISLODGMENT. PATIENT ASKED WHY TO BELIEVE THE INFORMATION IN THE INSTRUCTIONS FOR USE (IFU) THAT DID NOT PROVIDE SUFFICIENT INFORMATION ABOUT THE PRODUCT AND ITS MEDICAL APPLICATION WHEN THEY WERE ASKED OF THE COMPLICATIONS WHILE USING THE URETHRAL STENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14054781 ↗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 ↗MalfunctionApr 8, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT CUSTOMER STATED THAT THE STENT HAD ENCRUSTATION. ALSO, THE PATIENT HAD SURGICAL SITE INFECTION AND STENT DISLODGMENT. PATIENT ASKED WHY TO BELIEVE THE INFORMATION IN THE INSTRUCTIONS FOR USE (IFU) THAT DID NOT PROVIDE SUFFICIENT INFORMATION ABOUT THE PRODUCT AND ITS MEDICAL APPLICATION WHEN THEY WERE ASKED OF THE COMPLICATIONS WHILE USING THE URETHRAL STENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14051890 ↗InjuryApr 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT CUSTOMER STATED THAT THE STENT HAD ENCRUSTATION. ALSO, THE PATIENT HAD SURGICAL SITE INFECTION AND STENT DISLODGMENT. PATIENT ASKED WHY TO BELIEVE THE INFORMATION IN THE INSTRUCTIONS FOR USE (IFU) THAT DID NOT PROVIDE SUFFICIENT INFORMATION ABOUT THE PRODUCT AND ITS MEDICAL APPLICATION WHEN THEY WERE ASKED OF THE COMPLICATIONS WHILE USING THE URETHRAL STENT. MEDICAL INTERVENTION WAS UNKNOWN.
Patient problems: Post Operative Wound Infection
MAUDE report 14046119 ↗MalfunctionApr 7, 2022Calcified; Calcified
IT WAS REPORTED THAT THE CUSTOMER STATED THAT THE STENT HAD ENCRUSTATION. ALSO, THE PATIENT HAD SURGICAL SITE INFECTION AND STENT DISLODGMENT. PATIENT ASKED WHY TO BELIEVE THE INFORMATION IN THE INSTRUCTIONS FOR USE (IFU) THAT DID NOT PROVIDE SUFFICIENT INFORMATION ABOUT THE PRODUCT AND ITS MEDICAL APPLICATION WHEN THEY WERE ASKED ABOUT THE COMPLICATIONS WHILE USING THE URETHRAL STENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14045344 ↗MalfunctionApr 6, 2022Calcified; Calcified
IT WAS REPORTED THAT CUSTOMER MENTIONED ABOUT FLANK PAIN, INCONTINENCE AND STENT ENCRUSTATION WHEN THEY WERE ASKED OF THE COMPLICATIONS WHILE USING THE URETHRAL STENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14022296 ↗MalfunctionApr 6, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT CUSTOMER MENTIONED ABOUT URGENCY, DYSURIA, FLANK PAIN, HEMATURIA, URINARY TRACT INFECTION, IRRITATIVE URINARY SYMPTOMS AND DISLODGEMENT WHEN THEY WERE ASKED OF THE COMPLICATIONS WHILE USING THE URETERAL STENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14022200 ↗InjuryApr 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE CUSTOMER MENTIONED ABOUT URGENCY, DYSURIA, FLANK PAIN, HEMATURIA, URINARY TRACT INFECTION, IRRITATIVE URINARY SYMPTOMS AND DISLODGMENT WHEN THEY WERE ASKED ABOUT THE COMPLICATIONS WHILE USING THE URETERAL STENT. MEDICAL INTERVENTION WAS UNKNOWN.
Patient problems: Hematuria; Micturition Urgency; Urinary Tract Infection
MAUDE report 14022058 ↗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 ↗MalfunctionApr 6, 2022Migration; Migration
IT WAS REPORTED THAT THE CUSTOMER MENTIONED ABOUT FLANK PAIN AND STENT MIGRATION WHEN THEY WERE ASKED ABOUT THE COMPLICATIONS WHILE USING THE URETERAL STENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14021668 ↗MalfunctionApr 1, 2022Migration; Migration
IT WAS REPORTED THAT THE USER EXPERIENCED INCOMPLETE EMPTYING, HEMATURIA, STENT MIGRATION AND DISLODGMENT WHILE USING THE URETERAL STENTS. MEDICAL INTERVENTION WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13980834 ↗MalfunctionApr 1, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE USER EXPERIENCED INCOMPLETE EMPTYING, HEMATURIA, STENT MIGRATION AND DISLODGMENT WHILE USING URETERAL STENTS. MEDICAL INTERVENTION WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13980437 ↗
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
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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