Contour VL™ M006180156190Recalls & reported problems
Boston Scientific Corporation · Variable Length Ureteral Stent Set · Class 2 · Implant
All models of Contour VL (12)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729765837), received between Apr 22, 2024 and Oct 28, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Nov 16, 2020Class IIOpen, Classified
Trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris was confirmed to be particles of nickel.
Z-0758-2021 · Root cause: Process design · Recall details · FDA record ↗
Most reported problems
Device problems
- Break1
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 28, 2024Break; Break
DURING THE INSERTION OF A RIGID URETEROSCOPY PROCEDURE, THE DEVICE WAS FOUND BROKEN. IT WAS NOTED THAT THE STENT WAS BROKEN INTO TWO PIECES ALONG THE SHAFT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME STENT AND THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20551099 ↗MalfunctionApr 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING THE PROCEDURE, THE TIP OF THE STENT WAS FOUND BROKEN. IT WAS NOTED THAT THE STENT AND THE BROKEN TIP WAS REMOVED FROM PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE AND THERE WERE NO PATIENT COMPLICATIONS. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19160797 ↗
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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page