Bard® InLay Optima® Ureteral Stent with HydroGlide™ Guidewire 787826Recalls & reported problems
C. R. Bard, Inc. · INLAY OPTIMA URETERAL STENT W/HYDROGLIDE GUIDEWIRE · Class 2 · Implant
All models of Bard InLay Optima Ureteral Stent with HydroGlide Guidewire (12)
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 10801741015608), received between Jun 15, 2018 and Jun 17, 2025 — classified as 1 injury, 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.
Reports received per month
Most reported problems
Device problems
- Biocompatibility1
- Component Missing1
- Device Contamination with Chemical or Other Material1
- Patient Device Interaction Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 17, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT BEFORE USE, THERE WAS SOMETHING LIKE DUST MIXED IN THE URETERAL STENT. THAT WAS DELIVERED TO THE HOSPITAL AT THE AGENCY DISCRETION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22236026 ↗InjuryNov 9, 2021Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION WHILE USING THE URETERAL STENT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR THE INFECTION.
Patient problems: Unspecified Infection
MAUDE report 12779941 ↗MalfunctionJun 15, 2018Component Missing
IT WAS REPORTED THAT, UPON OPENING THE PACKAGE, THE STENT WAS MISSING FROM THE KIT.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 7606471 ↗
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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