Bard® InLay® Ureteral Stent 778428Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741014772), received between Mar 5, 2018 and Nov 29, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Damaged Prior to Receipt by User” (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
- Device Damaged Prior to Receipt by User1
- Device Expiration Issue1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 29, 2022Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User
IT WAS REPORTED THAT THE CUSTOMER RECEIVED A WRONG PRODUCT INSTEAD OF URETERAL STENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15879691 ↗MalfunctionMar 5, 2018Device Expiration Issue
IT WAS REPORTED THAT, AFTER THE URETERAL STENT WAS INSERTED INTO THE PATIENT, IT WAS NOTICED THAT THE DEVICE HAD EXCEEDED THE EXPIRATION DATE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7313127 ↗
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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