Contour™ M0061802240Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729058564), received between Jun 17, 2020 and Oct 24, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 24, 2025Deformation Due to Compressive Stress; Difficult to Advance; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT A CONTOUR URETERAL STENT WAS USED IN A URETEROSCOPY PROCEDURE IN THE URETER. DURING THE PROCEDURE, WHEN THE STENT WAS INSERTED OVER THE WIRE, IT GOT STUCK AND IT WAS NOTICED THAT THE STENT BUCKLED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23386398 ↗
• MalfunctionAug 28, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE STENT DID NOT UNCOIL FROM THE RENAL END DURING REMOVAL, WHICH CAUSES CONCERN FOR PATIENT SAFETY. THERE WAS NO INFORMATION ON WHEN THE PROBLEM WAS NOTICED, ON WHAT COMPLETED THE PROCEDURE AND ON THE CONDITION OF THE PATIENT FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22916807 ↗
• MalfunctionAug 26, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE STENT DID NOT UNCOIL FROM THE RENAL END DURING REMOVAL, WHICH CAUSES CONCERN FOR PATIENT SAFETY. THERE WAS NO INFORMATION ON WHEN THE PROBLEM WAS NOTICED, ON WHAT COMPLETED THE PROCEDURE AND ON THE CONDITION OF THE PATIENT FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22898849 ↗
• MalfunctionJun 7, 2025Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS REPORTED THAT A CONTOUR URETERAL STENT WAS TO BE USED IN A STENT EXCHANGE PROCEDURE. DURING UNPACKING, THE STENT WAS FOUND BROKEN AND TORN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22163218 ↗
• MalfunctionMay 28, 2025Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CONTOUR STENT WAS TO BE USED IN A PROCEDURE FOR URETERAL CALCULI. DURING UNPACKING, IT WAS FOUND THAT THE TIP OF THE COIL WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22093786 ↗
• MalfunctionFeb 11, 2025Difficult to Advance; Material Split, Cut or Torn; Difficult to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT A CONTOUR URETERAL STENT WAS USED DURING A URETEROSCOPY PROCEDURE. DURING THE PROCEDURE WHILE INSIDE THE PATIENT, THE STENT WAS DIFFICULT TO DEPLOY, RESULTING IN THE STENT AND THE GUIDEWIRE BECOMING SHREDDED WHILE RETRACTING THE WIRE TO DEPLOY THE STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21356510 ↗
• MalfunctionFeb 10, 2025Difficult to Advance; Material Split, Cut or Torn; Difficult to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT A CONTOUR URETERAL STENT WAS USED DURING A URETEROSCOPY PROCEDURE, AND, DURING THE PROCEDURE, THE STENT WAS DIFFICULT TO DEPLOY, RESULTING FOR THE STENT AND THE GUIDEWIRE TO BECOME SHREDDED WHILE RETRACTING THE WIRE TO DEPLOY THE STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21351683 ↗
• MalfunctionSep 2, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A CONTOUR URETERAL STENT WAS USED DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, IT WAS NOTED THAT THE STENT SEPARATED OR FELL APART. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER POLARIS ULTRA URETERAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17674851 ↗
• MalfunctionJun 17, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR URETERAL STENT WAS USED DURING A STENT PLACEMENT PROCEDURE IN THE URETER AND BLADDER. THE EXACT EVENT DATE WAS NOT REPORTED. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN REMOVED THE DEVICE FROM THE PACKAGE, THE STENT SHAFT WAS FOUND TO BE BROKEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER CONTOUR URETERAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10163365 ↗