Bard® Fluoro-4™ Silicone Ureteral Stent 233624Recalls & reported problems
C. R. Bard, Inc. · Bard® Fluoro-4™ Silicone Ureteral Stent with Hydro-Glide™ Guidewire · Class 2 · Implant
All models of Bard Fluoro-4 Silicone Ureteral Stent (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10801741011679), received between Sep 6, 2017 and Apr 22, 2022 — classified as 13 malfunctions.
The most frequently reported specific device problem is “Break” (8 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
Device problems
- Break8
- Component Missing1
- Device Damaged Prior to Use1
- Device Dislodged or Dislocated1
- Failure to Advance1
- Inaccurate Flow Rate1
- Incorrect Measurement1
- Material Fragmentation1
Patient problems
- No Known Impact Or Consequence To Patient5
- No Clinical Signs, Symptoms or Conditions4
- No Patient Involvement3
- No Information2
- Urinary Retention1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
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 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 ↗MalfunctionApr 1, 2022Inaccurate Flow Rate; Inaccurate Flow Rate
IT WAS REPORTED THAT THE USER EXPERIENCED INCOMPLETE EMPTYING, HEMATURIA, STENT MIGRATION AND DISLODGMENT WHILE USING URETERAL STENTS. MEDICAL INTERVENTION WAS UNKNOWN.
Patient problems: Urinary Retention
MAUDE report 13980220 ↗MalfunctionDec 26, 2021Component Missing; Component Missing
IT WAS REPORTED THAT THERE WAS NO URETERAL STENT IN THE INNER PACKAGING. THE CUSTOMER USED ANOTHER NEW URETERAL STENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13085711 ↗MalfunctionSep 25, 2019Partial Blockage; Break; Partial Blockage
IT WAS REPORTED THAT THE END TIP OF THE STENT WAS EMBRITTLED AND BROKEN PRIOR TO USE.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 9117645 ↗MalfunctionMay 9, 2019Break; Device Damaged Prior to Use
IT WAS REPORTED THAT THE GUIDE WIRE WAS FOUND BROKEN UPON OPENING THE PACKAGE.
Patient problems: No Patient Involvement
MAUDE report 8596596 ↗MalfunctionSep 10, 2018Break; Incorrect Measurement; Failure to Advance; Incorrect Measurement
IT WAS REPORTED THAT THE STENT SEEMED TOO NARROW AND CAUSED THE GUIDEWIRE NOT TO PASS THROUGH, SUBSEQUENTLY THE STENT BROKE WHILE TRYING TO REMOVE IT FROM THE GUIDEWIRE.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 7862000 ↗MalfunctionSep 7, 2017Break
IT WAS REPORTED THAT THE STENT WAS BROKEN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6847711 ↗MalfunctionSep 6, 2017Break
MalfunctionSep 6, 2017Break
IT WAS REPORTED THAT THE STENT WAS BROKEN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6846435 ↗MalfunctionSep 6, 2017Break
IT WAS REPORTED THAT THE STENT WAS BROKEN. THE AFFECTED DEVICE HAS EITHER ONE OF THE LOT #, NGBN 2439 OR NGAW 4423, AS PROVIDED BY THE HEAD OR NURSE.
Patient problems: No Information
MAUDE report 6846302 ↗MalfunctionSep 6, 2017Break
IT WAS REPORTED THAT THE STENT WAS BROKEN. THE AFFECTED DEVICE HAS EITHER ONE OF THE LOT #'S, NGBN2439 OR NGAW4423, AS PROVIDED BY THE HEAD OR NURSE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6846299 ↗
Other STENT, URETERAL devices
- Bard® InLay Optima® Ureteral Stent 788426C. R. Bard, Inc. · STENT, URETERAL1 recall100 reports
- Bard® InLay Optima® Ureteral Stent 788626C. R. Bard, Inc. · STENT, URETERAL122 reports
- Bard® InLay® Ureteral Stent with HydroGlide™ Guidewire 777626C. R. Bard, Inc. · STENT, URETERAL118 reports
- Bard® InLay® Ureteral Stent with HydroGlide™ Guidewire 777426C. R. Bard, Inc. · STENT, URETERAL108 reports
- Bard® InLay® Ureteral Stent 778626C. R. Bard, Inc. · STENT, URETERAL100 reports
- Percuflex™ Plus M0061752530Boston Scientific Corporation · STENT, URETERAL1 death99 reports
- Contour VL™ M0061801560Boston Scientific Corporation · STENT, URETERAL1 recall45 reports
- Polaris™ Ultra M0061921330Boston Scientific Corporation · STENT, URETERAL71 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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