Bard® InLay® Ureteral Stent with NiCore™ Guidewire 776426Recalls & reported problems
C. R. Bard, Inc. · INLAY URETERAL STENT W/NITINOL GUIDEWIRE · Class 2 · Implant
All models of Bard InLay Ureteral Stent with NiCore Guidewire (7)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10801741014205), received between Oct 10, 2022 and Jun 26, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (4 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 Fragmentation4
- Difficult to Insert2
- Difficult to Advance1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 26, 2026Difficult to Insert; Difficult to Advance
IT WAS REPORTED THAT THE PHYSICIAN OPENED THE STERILE PACKAGING, REMOVED THE STENT AND GUIDEWIRE, LUBRICATED THEM WITH STERILE WATER, AND ASSEMBLED THE STENT AND GUIDEWIRE IN PREPARATION FOR CATHETERIZATION. DURING THE PROCEDURE, IT WAS DISCOVERED THAT ONCE PART OF THE STENT HAD ENTERED THE PATIENT¿S BODY, IT COULD NO LONGER BE ADVANCED, RESULTING IN A FAILED CATHETERIZATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25643267 ↗MalfunctionMar 20, 2023Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE URETERAL STENT WAS RUPTURED UPON UNPACKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16578727 ↗MalfunctionNov 7, 2022Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT THE URETERAL STENT COULD NOT BE PUSHED INTO THE PELVIS DURING OPERATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15744690 ↗MalfunctionNov 7, 2022Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE URETERAL STENT WAS RUPTURED UPON OPENING OF THE PACKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15743461 ↗MalfunctionOct 10, 2022Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE URETERAL STENT WAS BROKEN IN THE PACKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15572816 ↗MalfunctionOct 10, 2022Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED TO UNDERGO HOLMIUM LASER LITHOTRIPSY FOR RIGHT URETERAL CALCULI AND RIGHT URETERAL STENT IMPLANTATION UNDER COMBINED SPINAL-EPIDURAL ANESTHESIA ON (B)(6)2022. DURING THE OPERATION, THE DEVICE PACKAGING OF URETERAL STENT WAS OPENED, AND THE URETERAL STENT WAS FOUND TO BE BROKEN. IT WAS MENTIONED THAT THE STENT COULD NOT BE USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15572731 ↗
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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