Contour VL™ M006180157010Recalls & 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
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729058434), received between Nov 13, 2018 and Oct 30, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Calcified” (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
- Calcified1
- Unsealed Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 30, 2023Unsealed Device Packaging; Unsealed Device Packaging
IT WAS REPORTED THAT A CONTOUR VL URETERAL STENT WAS OPENED TO BE USED DURING A URETEROSCOPY PROCEDURE IN THE URETHRA FOR STONE MANAGEMENT PERFORMED ON (B)(6) 2023. DURING PREPARATION, A TEAR WAS FOUND IN THE PACKAGING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER CONTOUR VL URETERAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THAT THE PACKAGING SEAL WAS COMPROMISED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18028224 ↗MalfunctionNov 13, 2018Calcified; Calcified
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR STENT WAS IMPLANTED DURING A URETEROSCOPY WITH STONE FRAGMENTATION AND DOUBLE J IMPLANTATION PROCEDURE. THE EVENT DATE WAS NOT PROVIDED. ACCORDING TO THE COMPLAINANT, DURING WITHDRAWAL, IT WAS NOTICED THAT THE STENT WAS ENCRUSTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENTS CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS NOTED TO BE STABLE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8064112 ↗
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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