Contour VL™ M0061801560Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 08714729067986), received between Oct 10, 2017 and Aug 31, 2026 — classified as 3 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Break” (16 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 25 most recent of 45 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2026Break

  It was reported that a Contour Ureteral Stent was to be used in a Retrograde Intrarenal Surgery with Flexible ureteroscope procedure. During preparation, it was found that the stent was torn. The procedure was completed with another of the same device and there were no patient complications reported. A photo of the complaint device was provided and showed that the stent shaft was broken.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50515516 ↗
• InjuryAug 12, 2026Difficult or Delayed Positioning; Detachment of Device or Device Component

  It was reported that a Contour Ureteral stent was used in a Ureteral stent placement procedure in the ureter. During the procedure, the physician had difficulty placing the stent requiring multiple attempts, and it was noticed that a portion of the distal coil broke. It was reported that the broken fragment was very small and was left in the ureter alongside with another existing stent. A Computed Tomography scan (CT-scan) was performed, and the broken piece of stent was retrieved through cystoscope in a subsequent procedure. There was no information if a new stent was placed. There were no other patient complications and the patient's condition at the conclusion of the procedure was reported to be stable.

  Patient problems: Foreign Body In Patient

  MAUDE report 50225891 ↗
• MalfunctionApr 24, 2026Difficult to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT A CONTOUR URETERAL STENT WAS USED IN A URETEROSCOPY PROCEDURE IN THE URETER. DURING THE PROCEDURE, WHILE ATTEMPTING TO DEPLOY THE STENT, IT WAS NOTICED THAT THE STENT WAS 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 24990257 ↗
• MalfunctionOct 20, 2025Nonstandard Device; Deformation Due to Compressive Stress; Difficult to Advance; Nonstandard Device; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT A CONTOUR URETERAL STENT WAS USED IN A FLEXIBLE URETEROSCOPY & INSERTION OF URETERIC STENT IN THE KIDNEY, URETER AND BLADDER. DURING THE PROCEDURE, WHEN THE GUIDEWIRE WAS REMOVED, IT GOT STUCK, CAUSING FOR THE STENT TO RECOIL. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. A PICTURE PROVIDED BY THE CUSTOMER SHOWED THAT THE STENT WAS BUCKLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23337464 ↗
• MalfunctionAug 15, 2025Break; Break

  IT WAS REPORTED THAT A CONTOUR URETERAL STENT WAS USED IN A URETEROSCOPY PROCEDURE IN THE URETER. DURING THE PROCEDURE, THE STENT BROKE AND WAS SPLIT INTO TWO PARTS. 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 22820723 ↗
• MalfunctionMar 17, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A COTOUR VL STENT WAS TO BE USED IN A URETEROSCOPY WITH LASER LITHORIPSY PROCEDURE, AND, DURING PREPARATION WHEN THE SUTURE WAS REMOVED FOR INSERTION, THE STENT BROKE INTO TWO PIECES ALONG THE SHAFT. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21620731 ↗
• MalfunctionFeb 4, 2025Break; Break

  IT WAS REPORTED THAT A CONTOUR STENT WAS TO BE EXPLANTED FROM THE PATIENT DURING A STENT REMOVAL PROCEDURE. DURING THE PROCEDURE, THE STENT BROKE IN TWO. THE BROKEN STENT WAS COMPLETELY RETRIEVED FROM THE PATIENT AND 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 21308727 ↗
• MalfunctionFeb 4, 2025Break; Break

  IT WAS REPORTED THAT A CONTOUR VL URETERAL STENT WAS TO BE USED IN A STENT EXCHANGE PROCEDURE, AND DURING PREPARATION, IT WAS FOUND THAT THE STENT WAS FRACTURED. 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 21308657 ↗
• MalfunctionJan 8, 2025Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT A CONTOUR URETERAL STENT WAS TO BE USED IN A STONE CASE PROCEDURE. DURING UNPACKING, THE STENT WAS FOUND OUTSIDE THE INNER PLASTIC HOLDER, COMPROMISING THE STERILITY OF THE DEVICE. 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 21103477 ↗
• InjuryDec 30, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT A CONTOUR STENT WAS USED DURING A KIDNEY STONE PROCEDURE. DURING INSERTION, WHILE POSITIONING THE STENT, IT WAS NOTED THAT THE STENT ACCORDIONED CAUSING TRAUMA TO THE URETER. THE PROCEDURE WAS COMPLETED WITH A NEPHROTOMY TUBE. THE PATIENT WAS GIVEN WITH LASIK AND TORADOL AS MEDICATION AND HAVE TO BE KEPT IN WATCH IN THE HOSPITAL OVERNIGHT. THERE WERE NO FURTHER COMPLICATIONS, AND THE PATIENT'S CONDITION WAS REPORTED TO BE STABLE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21043492 ↗
• MalfunctionDec 30, 2024Calcified; Calcified

  IT WAS REPORTED THAT A CONTOUR STENT WAS IMPLANTED TO A PATIENT. TWO WEEKS LATER, A URETEROSCOPY WITH PLANNED STENT REMOVAL PROCEDURE WAS PERFORMED, IT WAS FOUND THAT THE STENT WAS CALCIFIED. THE STENT WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND THERE WAS NO NEW STENT REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21037201 ↗
• MalfunctionDec 30, 2024Calcified; Calcified

  IT WAS REPORTED THAT A CONTOUR STENT WAS IMPLANTED TO THE PATIENT. POST PROCEDURE, A URETEROSCOPY WITH PLANNED STENT REMOVAL PROCEDURE WAS PERFORMED, AND, IT WAS FOUND THAT THE STENT WAS CALCIFIED. THE STENT WAS REMOVED SUCCESSFULLY FROM THE PATIENT AND THERE WAS NO NEW STENT REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21037195 ↗
• MalfunctionDec 27, 2024Calcified; Calcified

  IT WAS REPORTED THAT THREE WEEKS AFTER A CONTOUR STENT WAS IMPLANTED TO THE PATIENT, A STENT REMOVAL PROCEDURE WAS PERFORMED AND IT WAS OBSERVED THAT THE STENT WAS CALCIFIED. THE STENT WAS SUCCESSFULLY EXPLANTED WITH THE USE OF A PAIR OF FORCEPS AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21029677 ↗
• MalfunctionApr 18, 2024Device-Device Incompatibility; Material Split, Cut or Torn; Device-Device Incompatibility; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR VL URETERAL STENT WAS USED DURING A STENT INSERTION PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE SENSOR WIRE FOR STENT PLACEMENT, THE SENSOR WIRE WAS STUCK ONTO THE STENT. THE STENT BECAME SHREDDED, AND THE WIRE UNCOILED ITSELF. THE GUIDEWIRE AND STENT WERE REMOVED FROM THE PATIENT WITHOUT A PROBLEM. ANOTHER STENT AND GUIDEWIRE COMPLETED THE PROCEDURE. 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 19134820 ↗
• MalfunctionMay 23, 2023Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR VL URETERAL STENT WAS OPENED TO BE USED IN AN UNSPECIFIED PROCEDURE ON AN UNKNOWN DATE. IT WAS NOTED THAT THE MATERIAL WRAPPED ON THE GUIDE WIRE AND WHEN THEY TRIED TO REMOVE, THE DOUBLE J WAS WORN OUT. 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 16989288 ↗
• MalfunctionMay 23, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR VL URETERAL STENT WAS OPENED TO BE USED IN AN UNSPECIFIED PROCEDURE ON AN UNKNOWN DATE. DURING UNPACKING, IT WAS FOUND THAT THE DEVICE WAS BROKEN. 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 16987290 ↗
• MalfunctionMay 19, 2023Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR VL URETERAL STENT WAS OPENED TO BE USED IN AN UNSPECIFIED PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, IT WAS NOTED THAT THE MATERIAL HAD A MALFUNCTION. 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 16964716 ↗
• MalfunctionMay 18, 2023Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A CONTOUR VL URETERAL STENT WAS TO BE USED DURING A STENT PLACEMENT PROCEDURE, PERFORMED ON (B)(6) 2023. DURING PREPARATION, WHEN THE DEVICE WAS UNPACKED, IT WAS FOUND THAT THE STENT WAS BROKEN. ANOTHER CONTOUR VL URETERAL STENT WAS OPENED AND USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16951148 ↗
• MalfunctionFeb 13, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR VL URETERAL STENT WAS USED DURING A STENT PLACEMENT PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, WHILE INSERTING THE STENT INTO THE URETERAL ORIFICE, IT TORE. IT WAS NOTED THAT THE STENT SHAFT BROKE INTO TWO PIECES ALONG THE SHAFT AND WAS COMPLETELY REMOVED USING A GRASPER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16368305 ↗
• MalfunctionMay 4, 2022Break; Detachment of Device or Device Component; Material Deformation; Break; Detachment of Device or Device Component; Material Deformation

  NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO DEVICES THAT WERE USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR URETERAL STENT WAS USED DURING A FLEXIBLE URETEROSCOPY PROCEDURE IN THE KIDNEY, PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, WHEN THE STENT WAS ADVANCED FOR DEPLOYMENT, IT KINKED AT THE ENTRANCE AND THE EXIT TIP AND THE STENTS BREAKS AT THE DISTAL AND PROXIMAL PART. ANOTHER DIFFERENT MODEL OF URETERAL STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO KNOWN PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14282583 ↗
• MalfunctionMay 4, 2022Break; Detachment of Device or Device Component; Material Deformation; Break; Detachment of Device or Device Component; Material Deformation

  NOTE: THIS REPORT PERTAINS TO THE SECOND OF TWO DEVICES THAT WERE USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR URETERAL STENT WAS USED DURING A FLEXIBLE URETEROSCOPY PROCEDURE IN THE KIDNEY, PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, WHEN THE STENT WAS ADVANCED FOR DEPLOYMENT, IT KINKED AT THE ENTRANCE AND THE EXIT TIP AND THE STENTS BREAKS AT THE DISTAL AND PROXIMAL PART. ANOTHER DIFFERENT MODEL OF URETERAL STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO KNOWN PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14282568 ↗
• MalfunctionApr 21, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR URETERAL STENT WAS USED DURING A PROCEDURE, PERFORMED ON (B)(6) 2022. DURING UNPACKING, IT WAS FOUND THAT THE STENT WAS BROKEN. THERE WERE NO INFORMATION ON HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14175004 ↗
• MalfunctionApr 4, 2022Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR VL URETERAL STENT WAS USED DURING A URETEROSCOPY PROCEDURE IN THE COMMON KIDNEY AND URINARY BLADDER, PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE PHYSICIAN FELT A BIT OF RESISTANCE DURING THE INITIAL PART OF INSERTION BUT IT WAS PUSHED THROUGH UNTIL DURING FULL DEPLOYMENT AND IT WAS NOTICED THAT THE STENT WAS KINKED. ANOTHER CONTOUR VL 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 14001918 ↗
• MalfunctionMar 2, 2022Difficult to Advance; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR VL URETERAL STENT WAS USED DURING A RETROGRADE INTRARENAL SURGERY PROCEDURE IN THE KIDNEY, URETER, AND BLADDER PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTED THAT THEY COULD NOT DEPLOY THE CONTOUR VL URETERAL STENT INSIDE THE PATIENT. IT WAS FOUND THAT THE STENT GRIPPED INTO THE GUIDEWIRE. 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. INVESTIGATION RESULTS REVEALED THAT THE STENT BUCKLED INSIDE THE PATIENT, THEREFORE THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13653701 ↗
• MalfunctionFeb 24, 2022Deformation 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 PERCUTANEOUS NEPHROLITHONOMY PROCEDURE IN THE KIDNEY, PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE AND INSIDE THE PATIENT, IT WAS NOTICED THAT THE STENT WAS BUCKLED. AN ALTERNATIVE 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 13595693 ↗