Bard® InLay Optima® Ureteral Stent 788826Recalls & 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
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741015922), received between Apr 4, 2025 and Jun 2, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Nov 6, 2025Class IIOpen, Classified
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Z-0908-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Material Fragmentation1
- Wrong Label1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 2, 2025Wrong Label; Wrong Label
IT WAS REPORTED THAT ON MAY 14, THE HOSPITAL OPERATING ROOM REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT URETEROSCOPY LITHOTRIPSY FOR KIDNEY STONES. THE SURGERY WAS PLANNED TO USE URETERAL STENT 788826. AFTER OPENING THE PACKAGE, IT WAS FOUND THAT THE PRODUCT WAS 788630. THE ACTUAL PRODUCT DID NOT MATCH THE OUTER PACKAGING AND NEEDED TO BE REPLACED WITH ANOTHER PACKAGE. AFTER REOPENING THE OTHER PACKAGE, THE URETERAL STENT WAS USED NORMALLY TO COMPLETE THE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22124385 ↗MalfunctionApr 4, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT BEFORE USE, D-J URETERAL STENT OUTER TUBE RUPTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21773094 ↗
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 · each recall links to the FDA recall notice
- 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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