Bard® InLay Optima® Multilength Ureteral Stent with NiCore™ Guidewire 786400Recalls & reported problems
C. R. Bard, Inc. · INLAY OPTIMA MULTI-LENGTH URETERAL STENT W/NITINOL GUIDEWIRE · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10801741014991), received between Dec 12, 2019 and Jul 25, 2022 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Biocompatibility” (1 report).
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
- Biocompatibility1
- Component Missing1
- Device Dislodged or Dislocated1
- Device Markings/Labelling Problem1
- Material Fragmentation1
- Patient Device Interaction Problem1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
- Unspecified Infection1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJul 25, 2022Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE DISTAL END OF THE URETERAL STENT BROKE OFF IN THE KIDNEY WHICH INCREASED THE SURGERY TIME BECAUSE IT WAS NECESSARY TO GO AND RETRIEVED THE SMALL PIECE OF CATHETER.
Patient problems: Foreign Body In Patient
MAUDE report 15096289 ↗InjuryNov 10, 2021Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION WHILE USING URETERAL STENT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR THE INFECTION.
Patient problems: Unspecified Infection
MAUDE report 12786083 ↗MalfunctionNov 9, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT EXPERIENCED STENT DISLODGEMENT AND MIGRATION WHILE USING THE URETERAL STENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12783100 ↗MalfunctionDec 12, 2019Component Missing; Component Missing; Device Markings/Labelling Problem
IT WAS REPORTED THAT THE BOX LABELED FOR A URETHRAL STENT HAD A NTINOL GUIDE WIRE IN IT INSTEAD.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 9461284 ↗
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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