Contour VL™ Injection Stent Set M0061856310Recalls & reported problems
Boston Scientific Corporation · Variable Length Injection Stent Set · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729340805), received between Apr 15, 2021 and Apr 15, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Remove” (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
- Difficult to Remove1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 15, 2021Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR INJECTION URETERAL STENT WAS IMPLANTED DURING A PROCEDURE IN THE KIDNEY AND URINARY BLADDER, PERFORMED ON (B)(6) 2021. ON (B)(6) 2021, THE PHYSICIAN ATTEMPTED TO REMOVE THE IMPLANTED STENT BUT IT WAS NOTICED THAT THE RIGHT STENT COULD ONLY BE PULLED OUT TO THE PENILE MEATUS. GENTLE FORCE WAS APPLIED TO REMOVE THE STENT BUT IT COULD NOT BE REMOVED DUE TO A KINK IN THE PROXIMAL PORTION, THUS IT WAS STUCK IN THE PROXIMAL URETER. THE PATIENT WAS SCHEDULED TO HAVE A CYSTO URETEROSCOPY THE FOLLOWING DAY SINCE THE OPERATING ROOM WAS NOT AVAILABLE. ON (B)(6) 2021, A CYSTO URETEROSCOPY FOR STENT REMOVAL WAS PERFORMED. THE PHYSICIAN ATTEMPTED TO PULL THE URETERAL STENT AGAIN BUT IT WAS STILL STUCK IN PROXIMAL URETER. A DIVIDING GLIDEWIRE WAS PLACED THROUGH THE STENT TO STRAIGHTEN THE STENT UNDER FLUOROSCOPIC GUIDANCE. THE STENT WAS REMOVED SUCCESSFULLY AND EASILY. NO CALCIFICATION WAS REPORTED AND THE NO NEW STENT WAS REPORTED TO BE IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS SENT TO PACU AFTER THE PROCEDURE IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11674917 ↗
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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