Bard® InLay Optima® Ureteral Stent with HydroGlide™ Guidewire 787830Recalls & 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
- 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 10801741015622), received between May 8, 2023 and May 9, 2023 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Calcified” (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
- Calcified1
- Device Dislodged or Dislocated1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Urethral Stenosis/Stricture1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 9, 2023Calcified; Calcified
IT WAS REPORTED THAT A PHYSICIAN STATED IN AN ONLINE SURVEY THAT THE PATIENT EXPERIENCED STONE FORMATION, EXTRAVASATION, FISTULA FORMATION, PAIN OR DISCOMFORT, HYDRONEPHROSIS PRIOR TO THE DEVICE PLACEMENT AND STONE FORMATION, URETERAL REFLUX, STENT DISLODGEMENT COMPLICATIONS WERE DIRECTLY ATTRIBUTABLE TO THE DEVICE AND URETERAL STRICTURE WAS NEEDED FOR STONE FORMATION IN RELATION TO INLAY OPTIMA URETERAL STENT WITH HYDROGLIDE GUIDEWIRE, 8.0 FR. X 30CM.
Patient problems: Urethral Stenosis/Stricture
MAUDE report 16895744 ↗MalfunctionMay 8, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT A PHYSICIAN STATED IN AN ONLINE SURVEY THAT THE PATIENT EXPERIENCED STONE FORMATION, EXTRAVASATION, FISTULA FORMATION, PAIN OR DISCOMFORT, HYDRONEPHROSIS PRIOR TO THE DEVICE PLACEMENT AND STONE FORMATION, URETERAL REFLUX, STENT DISLODGEMENT COMPLICATIONS WERE DIRECTLY ATTRIBUTABLE TO THE DEVICE AND URETERAL STRICTURE WAS NEEDED FOR STONE FORMATION IN RELATION TO INLAY OPTIMA URETERAL STENT WITH HYDROGLIDE GUIDEWIRE, 8.0 FR. X 30CM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16886038 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page