Bard® InLay Optima® Ureteral Stent with NiCore™ Guidewire 786414Recalls & reported problems
C. R. Bard, Inc. · INLAY OPTIMA URETERAL STENT W/NITINOL GUIDEWIRE · Class 2 · Implant
All models of Bard InLay Optima Ureteral Stent with NiCore Guidewire (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10801741015004), received between Nov 9, 2021 and Mar 11, 2022 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (2 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
- Material Fragmentation2
- Calcified1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 11, 2022Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE URETERAL STENT UNDERWENT CATHETER BREAKAGE WHEN USED BY THE CLINICIAN. A NEW STENT WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13735645 ↗InjuryNov 9, 2021Calcified; Calcified
IT WAS REPORTED THAT THE STENT WAS UNABLE TO BE REMOVED. IT WAS STATED THAT THE STENT WAS FOUND COVERED WITH CALCULI DURING THE EXAMINATION IN THE PATIENT AFTER ONE MONTH OF THE PLACEMENT. THE STENT WAS THEN BROKEN BY HOLMIUM LASER AND REMOVED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 12784089 ↗MalfunctionNov 9, 2021Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT AFTER THE OUTER PACKAGE WAS OPENED, THE TAIL END OF THE STENT WAS FOUND TO BE BROKEN AND THE COATING OF THE GUIDE WIRE FLAKED OFF IN THE KIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12783979 ↗
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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