Contour VL™ M006180155090Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729423768), received between Feb 15, 2018 and May 14, 2020 — classified as 1 injury, 1 malfunction.

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 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

Recent adverse event reports

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

• MalfunctionMay 14, 2020Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR VL URETERAL STENT WAS USED DURING A LASER URETEROSCOPY PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS STUCK ON THE GUIDEWIRE AND WAS UNABLE TO BE ADVANCED. WHEN THE STENT WAS PULLED OUT, IT BECAME SCRUNCHED UP. 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 NOTED TO BE STABLE. INVESTIGATION RESULTS REVEALED THAT THE STENT COIL WAS KNOTTED, THEREFORE THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10059531 ↗
• InjuryFeb 15, 2018Break; Calcified; Difficult to Remove; Break; Calcified; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR VL¿ STENT WAS TO BE REMOVED IN A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2018. THE STENT WAS REPORTED TO HAVE BEEN IMPLANTED TWO MONTHS PRIOR TO THIS DATE. WHEN REMOVAL WAS STARTED, THE RIGHT SIDE OF THE STENT WAS LIFTED WITH A GRASPER, AND SNAPPED. THE FRAGMENTS WERE UNABLE TO BE RETRIEVED. THE SECOND ATTEMPT WAS MADE IN REMOVING THE STENT, AND DIFFICULTY WAS ENCOUNTERED, ANOTHER SMALL PIECE OF THE STENT SNAPPED. THE URETEROSCOPE WAS NOT ABLE TO PROGRESS BEYOND THE BROKEN STENT BITS. THE STENT WAS ALSO NOTICED TO BE ENCRUSTED. IT WAS LASERED UNTIL IT WAS FREE OF STONE. THE FRAGMENTS WERE RETRIEVED, AND THE URETER WAS REPORTED TO BE INTACT. THE STENT PIECES THAT BROKE OFF WERE UNABLE TO BE RETRIEVED AND WERE LEFT TO PASS NATURALLY. FURTHER RETROGRADE WAS REQUIRED, AND ANOTHER CONTOUR VL¿ STENT WAS IMPLANTED FOR A TWO WEEK DURATION. 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 "GOOD".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7272641 ↗