Bard® InLay® Ureteral Stent with HydroGlide™ Guidewire 777424Recalls & reported problems
C. R. Bard, Inc. · INLAY URETERAL STENT W/HYDROGLIDE GUIDEWIRE · Class 2 · Implant
All models of Bard InLay Ureteral Stent with HydroGlide Guidewire (17)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10801741014472), received between Dec 13, 2019 and Nov 27, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break1
- Device Damaged Prior to Use1
- Difficult to Insert1
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 27, 2023Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT AFTER THE SURGERY BEGAN, THE PACKAGE WAS OPENED AND THE URETERAL STENT TUBE WAS BROKEN, SO IT WAS REPLACED WITH ANOTHER STENT. PER ADDITIONAL INFORMATION VIA EMAIL FROM IBC ON 16NOV2023, THE TAIL END OF THE PHYSICAL PIG IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18209408 ↗MalfunctionOct 20, 2022Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT THE BRACKET OF THE URETERAL STENT HAD HIGH FRICTION AND COULD NOT BE PUT IN. THE USER CHANGED TO A NEW DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15638213 ↗MalfunctionDec 13, 2019Break; Device Damaged Prior to Use
IT WAS REPORTED THAT THE PIGTAIL END OF THE URETERAL STENT WAS FOUND BROKEN WHEN THE PACKAGE WAS OPENED.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 9465710 ↗
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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