Bard® InLay Optima® Ureteral Stent 788824Recalls & reported problems
C. R. Bard, Inc. · INLAY OPTIMA URETERAL STENT W/O GUIDEWIRE · Class 2 · Implant
All models of Bard InLay Optima Ureteral Stent (21)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741015915), received between Jan 21, 2022 and Jan 21, 2022 — classified as 1 injury, 1 malfunction.
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
- Calcified1
- Patient Device Interaction Problem1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Hemorrhage/Blood Loss/Bleeding1
- No Clinical Signs, Symptoms or Conditions1
- Swelling/ Edema1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 21, 2022Calcified; Calcified
IT WAS REPORTED THAT THE PATIENT EXPERIENCED STONE FORMATION AND STENT ENCRUSTATION, EDEMA, URETERAL REFLUX, HEMORRHAGE, INFECTION, PAIN AND DISCOMFORT WHILE USING THE BARD URETERAL STENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13314528 ↗InjuryJan 21, 2022Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED STONE FORMATION AND STENT ENCRUSTATION, EDEMA, URETERAL REFLUX, HEMORRHAGE, INFECTION, PAIN AND DISCOMFORT WHILE USING THE BARD URETERAL STENT. MEDICAL INTERVENTION WAS UNKNOWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding; Swelling/ Edema
MAUDE report 13314061 ↗
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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