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Contour VL™ M006180156090Recalls & reported problems

Boston Scientific Corporation · Variable Length Ureteral Stent Set · Class 2 · Implant

All models of Contour VL (12)

Data updated Oct 16, 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 08714729423829), received between Mar 25, 2019 and Apr 11, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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 16, 2026.

Recalls naming this device

  1. Nov 16, 2020Open, 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

  • Deformation Due to Compressive Stress1
  • Difficult to Advance1
  • Unsealed Device Packaging1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 11, 2022Deformation Due to Compressive Stress; Difficult to Advance; Deformation Due to Compressive Stress; Difficult to Advance

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN CONTOUR URETERAL STENT WAS USED DURING A URETERAL STENT IMPLANTATION PROCEDURE IN THE URINARY TRACT, PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, WHEN THE STENT WAS PUSHED INTO THE GUIDEWIRE, THE STENT BECAME BUCKLED/ACCORDIONED AND RESISTANCE WAS OBSERVED. ANOTHER CONTOUR URETERAL STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14077497 ↗
  • MalfunctionMar 25, 2019Unsealed Device Packaging; Unsealed Device Packaging

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR VL STENT WAS TO BE USED FOR AN UNKNOWN PROCEDURE, ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, WHEN BEING REMOVED FROM THE SHELF, THE PACKAGING OF THE STENT WAS NOTICED TO BE DAMAGED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE USE OF ANOTHER CONTOUR VL STENT. 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 Known Impact Or Consequence To Patient

    MAUDE report 8450156 ↗

Other STENT, URETERAL devices

All STENT, URETERAL devices →

Sources and updates

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