Bard® InLay Optima® Ureteral Stent 788622Recalls & reported problems
C. R. Bard, Inc. · INLAY OPTIMA URETERAL STENT W/O GUIDEWIRE · Class 2 · Implant
All models of Bard InLay Optima Ureteral Stent (21)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741015748), received between Aug 22, 2017 and Sep 18, 2026 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (5 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 Fragmentation5
- Break1
- Calcified1
- Material Split, Cut or Torn1
- No Display/Image1
- Nonstandard Device1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Use of Device Problem
It was reported that after the stent was inserted, one suture was cut and pulled. During this process, the distal end was unintentionally withdrawn, resulting in complete stent dislodgement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50818417 ↗MalfunctionMar 30, 2026No Display/Image; Nonstandard Device
IT WAS REPORTED THAT THE BEFORE USE IN THE SET OF INLAY OPTIMA STENT, PROVIDED PUSHER WAS TOO SHORT RELATIVE TO THE LENGTH OF THE URETERAL STENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24718709 ↗MalfunctionJan 13, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT BEFORE USING THE URETERAL STENT, THE PRODUCT WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21137012 ↗MalfunctionDec 9, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE THREAD AT THE END OF THE URETERAL STENT HAD BROKEN. PER ADDITIONAL INFORMATION RECEIVED ON 26NOV2024, IT WAS REPORTED THAT THERE WAS NO RESIDUAL MATERIAL INSIDE THE BODY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20879988 ↗MalfunctionAug 1, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE FRONT END OF THE URETERAL STENT WAS CRACKED AND WAS REPLACED WITH A NEW ONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19882447 ↗MalfunctionMar 28, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT TAIL OF URETERAL STENT HAS BEEN CUT OFF WHEN OPENING THE PACKAGE OF THE INLAY OPTIMA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18994834 ↗MalfunctionAug 9, 2023Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE END OF THE STENT WAS CUT OFF WHEN THE USER OPENED THE PACKAGE OF INLAY OPTIMA URETERAL STENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17489191 ↗MalfunctionSep 3, 2019Break; Material Split, Cut or Torn; Break
IT WAS REPORTED THAT THE STENT TIP WAS FOUND SPLIT PRIOR TO USE.
Patient problems: No Patient Involvement
MAUDE report 8957082 ↗MalfunctionAug 22, 2017Calcified
IT WAS REPORTED THAT A CALCIFIED FORMATION WAS OBSERVED ON THE URETERAL STENT UPON REMOVAL FROM THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6810256 ↗
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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