Bard® InLay® Versa Fit® Ureteral Stent 778400Recalls & reported problems
C. R. Bard, Inc. · INLAY VERSA FIT URETERAL STENT w/o GUIDEWIRE · Class 2 · Implant
All models of Bard InLay Versa Fit Ureteral Stent (4)
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 00801741014710), received between Nov 14, 2018 and Jan 18, 2024 — 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
- Incorrect Measurement1
- Physical Resistance/Sticking1
- Use of Device Problem1
Patient problems
- No Known Impact Or Consequence To Patient2
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact 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.
MalfunctionJan 18, 2024Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT CUSTOMER HAD A DEFECTIVE STENT DURING SURGERY. THE PUSHER (ORANGE) WAS LARGER IN LUMEN SIZE AND THE STENT, SO IT WAS SLIDING OVER THE STENT NOT PUSHING IT UP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18535032 ↗MalfunctionNov 15, 2018Break
IT WAS REPORTED THAT THE URETERAL STENT BROKE BEFORE USE.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 8074156 ↗MalfunctionNov 14, 2018Use of Device Problem; Use of Device Problem; Physical Resistance/Sticking
IT WAS REPORTED THAT THE URETERAL STENT BECAME STUCK TO THE GUIDEWIRE AND WOULD NOT GO UP THE PATIENT'S URETHRA. THERE WAS NO REPORTED IMPACT OR INJURY TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 8071929 ↗
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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