Contour VL™ M006180155010Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729058427), received between Feb 18, 2022 and Jul 15, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (4 reports).

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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT, DURING A RETROGRADE INTRARENAL SURGERY PROCEDURE, A CONTOUR VL STENT WAS USED. IT WAS FOUND THAT THE TIP OF THE BLADDER SIDE WAS TORN WHEN ADVANCING THE PUSHER FOR STENT PLACEMENT. ANOTHER OF THE SAME STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19744307 ↗
• MalfunctionJul 12, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT, DURING RETROGRADE INTRARENAL SURGERY, A CONTOUR VL STENT WAS USED. IT WAS FOUND THAT THE TIP OF THE BLADDER SIDE WAS TORN WHEN ADVANCING THE PUSHER FOR STENT PLACEMENT. ANOTHER OF THE SAME STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19735419 ↗
• MalfunctionDec 13, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR VL URETERAL STENT WAS OPENED TO BE USED DURING A STONE LASER CASE PROCEDURE PERFORMED ON (B)(6) 2023. DURING PREPARATION, WHEN THE DEVICE WAS UNPACKED, THE STENT WAS FOUND BROKEN IN TWO PIECES. 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 FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18320682 ↗
• MalfunctionJul 8, 2022Deformation Due to Compressive Stress; Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Deformation Due to Compressive Stress; Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR VL URETERAL STENT WAS USED DURING A REMOVAL OF KIDNEY STONES PROCEDURE IN THE RIGHT KIDNEY PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, WHEN THE STENT WAS INTRODUCED AND PASSED THROUGH THE URETHRA AND ENTERED THE FORCED OF TWO CENTIMETERS INTO THE URETER, AND WHEN THE STENT WAS PUSHED, IT BECAME BUCKLED AND WOULD NOT ADVANCE INTO THE URETER AND A TORN WAS OBSERVED ON THE DISTAL PART. 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. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14955455 ↗
• MalfunctionJul 7, 2022Deformation Due to Compressive Stress; Difficult to Advance; Material Split, Cut or Torn; Deformation Due to Compressive Stress; Difficult to Advance; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR VL URETERAL STENT WAS USED DURING A REMOVAL OF KIDNEY STONES PROCEDURE IN THE RIGHT KIDNEY PERFORMED ON (B)(6), 2022. DURING THE PROCEDURE, WHEN THE STENT WAS INTRODUCED AND PASSED THROUGH THE URETHRA AND ENTERED THE FORCED OF TWO CENTIMETERS INTO THE URETER, AND WHEN THE STENT WAS PUSHED, IT BECAME BUCKLED AND WOULD NOT ADVANCE INTO THE URETER AND A TORN WAS OBSERVED ON THE DISTAL PART. 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. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14950119 ↗
• MalfunctionFeb 18, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR VL URETERAL STENT WAS USED DURING A STENT PLACEMENT PROCEDURE IN THE URETER. THE EVENT DATE WAS NOT REPORTED. DURING PREPARATION, IT WAS NOTED THAT THE CONTOUR VL URETERAL STENT WAS FOUND SEPARATED. 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 AS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13559738 ↗