Bard® InLay Optima® Multilength Ureteral Stent with HydroGlide™ Guidewire 787400Recalls & reported problems
C. R. Bard, Inc. · INLAY OPTIMA MULTI-LENGTH URETERAL STENT W/HYDROGLIDE 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 10801741015318), received between Nov 23, 2021 and Apr 1, 2024 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (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.
Reports received per month
Most reported problems
Device problems
- Patient Device Interaction Problem2
- Biocompatibility1
- Calcified1
- Partial Blockage1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- No Clinical Signs, Symptoms or Conditions2
- Pain2
- Discomfort1
- Hematuria1
- Unspecified Infection1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryApr 1, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN ADVERSE EVENT DIRECTLY ATTRIBUTABLE TO THE DEVICE 787400 - INLAY OPTIMA MULTI-LENGTH URETERAL STENT WITH HYDROGLIDE GUIDEWIRE, 4.7 FR., 22 ¿ 32CM AND THE PATIENT EXPERIENCED URETERAL REFLUX, PAIN/DISCOMFORT AND HEMATURIA. THIS DID NOT RESULT IN THE PATIENT INJURY REQUIRING MEDICAL OR SURGICAL INTERVENTION
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Hematuria; Pain
MAUDE report 19010804 ↗MalfunctionNov 24, 2021Calcified; Calcified
IT WAS REPORTED THAT THE USER EXPERIENCED URETERAL REFLUX, PAIN OR DISCOMFORT, INFECTION, OCCLUSION AND STENT ENCRUSTATION WHILE USING THE URETERAL STENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12870044 ↗MalfunctionNov 24, 2021Partial Blockage; Partial Blockage
IT WAS REPORTED THAT THE USER EXPERIENCED URETERAL REFLUX, PAIN OR DISCOMFORT, INFECTION, OCCLUSION AND STENT ENCRUSTATION WHILE USING THE URETERAL STENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12869895 ↗InjuryNov 23, 2021Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem
IT WAS REPORTED THAT THE USER MENTIONED THE FOLLOWING COMPLICATIONS: URETERAL REFLUX, PAIN/DISCOMFORT, INFECTION, OCCLUSION, STENT ENCRUSTATION WHILE USING THE URETERAL STENT. MEDICAL INTERVENTION WAS UNKNOWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain; Unspecified Infection
MAUDE report 12860215 ↗
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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