Contour VL™ M0061801570Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729068020), received between Oct 5, 2017 and Dec 30, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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-0757-2021 · Root cause: Process design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2024Device Contamination with Chemical or Other Material; Material Split, Cut or Torn; Device Contamination with Chemical or Other Material; Material Split, Cut or Torn

  IT WAS REPORTED THAT A CONTOUR STENT WAS TO BE USED IN A URETEROSCOPY PROCEDURE. DURING UNPACKING, IT WAS FOUND THAT THERE WAS A SLIGHT TEAR ON THE STENT THAT LOOKED LIKE A FUZZY MATERIAL. THE PROCEDURE WAS COMPETED WITH A NEW STENT AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21043503 ↗
• MalfunctionFeb 29, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR VL URETERAL STENT WAS OPENED TO BE USED TO TREAT KIDNEY STONES DURING A STENT INSERTION PROCEDURE PERFORMED ON (B)(6) 2021. DURING PREPARATION, WHEN THE DEVICE WAS REMOVED FROM PACKAGING, THE STENT WAS FOUND BROKEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER CONTOUR VL URETERAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. 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 18813263 ↗
• MalfunctionJun 25, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR VL STENT WAS SED DURING A STONE REMOVAL AND INSERTION OF JJ STENT PROCEDURE, PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTICED THAT THE STENT WAS BROKEN INTO TWO ALONG SHAFT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE USE OF ANOTHER CONTOUR VL STENT. THERE WAS NO SERIOUS INJURY, NOR WERE THERE ANY ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8732378 ↗
• InjuryOct 5, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR VL¿ STENT WAS USED DURING URETEROSCOPY PROCEDURE PERFORMED IN THE KIDNEY, URETER AND BLADDER ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, WHILE THE PHYSICIAN WAS ADVANCING THE CONTOUR VL STENT OVER THE GUIDEWIRE, THE STENT BECAME ACCORDION AND THE GUIDEWIRE RIPPED THE SIDE OF THE STENT. THE STENT COIL DETACHED NEAR THE LAST MARKER, AND THE DETACHED PIECE WAS REMOVED USING A STENT GRASPER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO REPORTED ISSUE AT THE CONCLUSION OF THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6915322 ↗