Bard® InLay® Ureteral Stent 778724Recalls & reported problems
C. R. Bard, Inc. · INLAY URETERAL STENT w/o GUIDEWIRE · Class 2 · Implant
All models of Bard InLay Ureteral Stent (11)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741014895), received between Jan 29, 2018 and Feb 12, 2024 — classified as 3 injuries.
The most frequently reported specific device problem is “Material Fragmentation” (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
- Material Fragmentation2
- Difficult to Remove1
- Kinked1
Patient problems
- Foreign Body In Patient2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Code Available1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryFeb 12, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE RADIOPAQUE PART OF A URETERAL STENT PUSHER BROKE OFF INSIDE THE PATIENT AND HAD TO BE REMOVED.
Patient problems: Foreign Body In Patient
MAUDE report 18684615 ↗InjuryOct 19, 2022Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE TIP OF THE URETERAL CATHETER BROKE OFF IN THE BLADDER WHEN THE DOCTOR WAS PLACING THE STENT AND THE DOCTOR HAD TO FISH IT OUT WITH A GRASPER.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body In Patient
MAUDE report 15631494 ↗InjuryJan 29, 2018Kinked; Difficult to Remove
IT WAS REPORTED THAT THE DEVICE WAS PLACED IN THE OPERATING ROOM. WHEN THE DOCTOR ATTEMPTED TO REMOVE THE STENT AT THE BEDSIDE, IT WAS UNABLE TO BE REMOVED. A KUB (X-RAY) WAS DONE AND SHOWED THAT THE STENT WAS KINKED IN THE URETER.
Patient problems: No Code Available
MAUDE report 7225219 ↗
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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