Contour VL™ M0061801550Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 08714729058410), received between Apr 11, 2018 and Jul 13, 2026 — classified as 4 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 13, 2026Break

  IT WAS REPORTED THAT, DURING STENT INSERTION A CONTOUR WAS USED PRIOR TO PROCEDURE. IT WAS DETERMINED THAT IT WAS BROKEN IN HALF AND NO LONGER BE USED. THE PROCEDURE WAS COMPLETED VIA ALTERNATIVE DEVICE USED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25806651 ↗
• MalfunctionDec 20, 2024Break; Break

  IT WAS REPORTED THAT A CONTOUR STENT WAS TO BE USED IN A URETERIC STENT PLACEMENT PROCEDURE, AND, DURING UNPACKING, THE STENT WAS FOUND FOLDED AND CUT. A PHOTO OF THE DEVICE SHOWED THAT THE STENT SHAFT WAS BROKEN. 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 20994568 ↗
• MalfunctionNov 13, 2024Difficult to Advance; Material Deformation; Adverse Event Without Identified Device or Use Problem; Difficult to Advance; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING INSERTION, THE DEVICE HAD DIFFICULTY ADVANCING AND THE PROBLEM WAS IDENTIFIED AT THE TIP OF THE STENT. PROCEDURE COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. THE CONDITION OF THE PATIENT AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20678232 ↗
• MalfunctionAug 26, 2024Break; Break

  IT WAS REPORTED THAT DURING PREPARATION PRIOR TO URETEROSCOPY PROCEDURE, THE CONTOUR VL STENT WAS NOTICED TO BE BROKEN INTO TWO PIECES ALONG THE SHAFT. ANOTHER OF THE SAME STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. THE CONDITION OF THE PATIENT AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20068656 ↗
• MalfunctionAug 3, 2023Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A CONTOUR VL URETERAL STENT WAS USED DURING A PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE STENT WAS TANGLED WITH GUIDE WIRE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER CONTOUR VL URETERAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THAT THE STENT DETACHED, STENT BUCKLED AND STENT TORN, INSIDE THE PATIENT, THEREFORE THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17455405 ↗
• MalfunctionSep 16, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR URETERAL STENT WAS USED DURING A URETEROLITHOTRIPSY PROCEDURE IN THE URETER, PERFORMED ON (B)(6) 2022. DURING UNPACKING, IT WAS NOTICED THAT THE STENT WAS BROKEN INTO TWO PARTS ALONG THE SHAFT. ANOTHER CONTOUR VL URETERAL STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO KNOWN 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 15442832 ↗
• MalfunctionMar 11, 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 STENT INSERTION IN THE URETER. DURING PROCEDURE, WHEN INSERTION WAS PERFORMED, IT WAS NOTED THAT THE CONTOUR VL URETERAL STENT ACCORDIONED UNDER THE LEAST AMOUNT OF PRESSURE FROM THE PUSHER AND WAS STUCK IN THE GUIDEWIRE WHEN PLACEMENT WAS PERFORMED ON AN UNKNOWN DATE. IT WAS REPORTED THAT THE CONTOUR VL URETERAL STENT KEEPS SHREDDING AND BREAKING APART. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13736550 ↗
• InjuryFeb 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR REPORT # 3005099803-2022-00463 AND MFR. REPORT # 3005099803-2022-00462). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DOUBLE-J CONTOUR URETERAL STENTS WERE USED DURING A STENT PLACEMENT PROCEDURE IN THE LEFT AND RIGHT URETER UNDER FLOUROSCOPY AND CYSTOSCOPY, PERFORMED ON (B)(6) 2021 AS PART OF THE U0652 DOUBLE-J REGISTRY CLINICAL STUDY. THE STENT PLACEMENT PROCEDURE WAS INDICATED FOR RENAL PAPILLARY NECROSIS. ON (B)(6) 2021, THE LEFT AND RIGHT SIDE STENT WAS SUCCESSFULLY IMPLANTED TO THE PATIENT. THE PATIENT WAS PRESCRIBED WITH ACETAMINOPHEN (TYLENOL), ANTIBIOTIC AND NARCOTIC ANALGESICS (OPIOIDS) AT DISCHARGE. NO ISSUES WERE NOTED WITH THE DEVICES. POST PROCEDURE, ON (B)(6) 2021, MODERATE FLANK PAIN WAS EXPERIENCED BY THE PATIENT. OXYCODONE AND OXYBUTYNIN 5MG WERE GIVEN AS MEDICATION FOR PAIN. THE EVENT WAS CONSIDERED TO BE RESOLVED AS OF (B)(6) 2022. ON (B)(6) 2022, THE STENTS WERE REMOVED SUCCESSFULLY IN THE OPERATING ROOM AS PER INITIAL PLAN. STENTS WERE NOT DIFFICULT TO REMOVE. PAIN CONTROL (GENERAL ANESTHESIA) WAS REQUIRED DURING STENT REMOVAL. THERE WERE NO NEW STENT IMPLANTED. IN THE PHYSICIA

  Patient problems: Pain

  MAUDE report 13486890 ↗
• InjuryFeb 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR REPORT # 3005099803-2022-00463 AND MFR. REPORT # 3005099803-2022-00462). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DOUBLE-J CONTOUR URETERAL STENTS WERE USED DURING A STENT PLACEMENT PROCEDURE IN THE LEFT AND RIGHT URETER UNDER FLOUROSCOPY AND CYSTOSCOPY, PERFORMED ON (B)(6) 2021 AS PART OF THE (B)(4) (B)(6)STUDY. THE STENT PLACEMENT PROCEDURE WAS INDICATED FOR RENAL PAPILLARY NECROSIS. ON (B)(6) 2021, THE LEFT AND RIGHT SIDE STENT WAS SUCCESSFULLY IMPLANTED TO THE PATIENT. THE PATIENT WAS PRESCRIBED WITH ACETAMINOPHEN (TYLENOL), ANTIBIOTIC AND NARCOTIC ANALGESICS (OPIOIDS) AT DISCHARGE. NO ISSUES WERE NOTED WITH THE DEVICES. POST PROCEDURE, ON (B)(6) 2021, MODERATE FLANK PAIN WAS EXPERIENCED BY THE PATIENT. OXYCODONE AND OXYBUTYNIN 5MG WERE GIVEN AS MEDICATION FOR PAIN. THE EVENT WAS CONSIDERED TO BE RESOLVED AS OF (B)(6) 2022. ON (B)(6) 2022, THE STENTS WERE REMOVED SUCCESSFULLY IN THE OPERATING ROOM AS PER INITIAL PLAN. STENTS WERE NOT DIFFICULT TO REMOVE. PAIN CONTROL (GENERAL ANESTHESIA) WAS REQUIRED DURING STENT REMOVAL. THERE WERE NO NEW STENTS IMPLANTED. IN THE PHYSICIAN'S ASSESSMEN

  Patient problems: Pain

  MAUDE report 13474366 ↗
• MalfunctionJan 6, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR URETERAL STENT WAS USED DURING A STENT PLACEMENT PROCEDURE , PERFORMED ON (B)(6) 2021. DURING PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, IT WAS NOTICED THAT THE STENT WAS RIPPED/TORN. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THE STENT WAS TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13179884 ↗
• MalfunctionDec 16, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR URETERAL STENT WAS USED DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2021. DURING INTRODUCTION, IT WAS NOTICED THAT THE STENT WAS RUPTURED. ANOTHER CONTOUR VL URETERAL STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO KNOWN PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. 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 13022608 ↗
• MalfunctionFeb 15, 2021Contamination; Material Deformation; Material Split, Cut or Torn; Contamination; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR VL URETERAL STENT WAS USED DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CONTOUR VL URETERAL STENT WAS TORTUOUS AT ONE EXTREMITY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. 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. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF FOREIGN MATERIAL PRESENT IN THE CONTOUR VL URETERAL STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11328003 ↗
• MalfunctionDec 4, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR VL URETERAL STENT WAS USED DURING A PROCEDURE ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, THE STENT WAS FOUND TO BE BROKEN. THERE WERE NO SERIOUS INJURY OR ADVERSE PATIENT EFFECT REPORTED AS A RESULT OF THIS EVENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8131275 ↗
• MalfunctionAug 27, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A CONTOUR VL STENT WAS OPENED FOR USE FOR A PROCEDURE TO BE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTICED THAT THE STENT WAS BROKEN INSIDE THE PACKAGE. THERE WERE NO SERIOUS INJURY OR ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT. ATTEMPTS TO OBTAIN FURTHER INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE, SHOULD ANY RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7819518 ↗
• InjuryMay 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR VL¿ STENT WAS IMPLANTED FOR A STENT PLACEMENT PROCEDURE AFTER THE REMOVAL OF KIDNEY STONES, ON (B)(6) 2018. THE STENT WAS REMOVED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, THE PATIENT WAS COMPLAINING OF PAIN AND THE PHYSICIAN REMOVED THE STENT. THE PATIENTS CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: Pain

  MAUDE report 7532239 ↗
• InjuryMay 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR VL¿ STENT WAS IMPLANTED IN THE URETER FOR A STENT PLACEMENT PROCEDURE ON (B)(6) 2018. THE STENT WAS EXPLANTED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, A DAY AFTER STENT IMPLANTATION, THE PATIENT WAS READMITTED TO THE HOSPITAL FOR STENT COLIC. A URETEROSCOPY WAS PERFORMED, AND A TORTUOUS ANATOMY WAS VISUALIZED. THE STENT WAS REMOVED. A CATHETER WAS PLACED FOR OBSERVATION. THE PATIENTS¿ CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: Pain

  MAUDE report 7532193 ↗
• MalfunctionApr 11, 2018Material Frayed; Material Frayed

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR VL¿ STENT WAS USED IN A STENT PLACEMENT PROCEDURE PERFORMED IN THE KIDNEY, URETER AND BLADDER ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, THE PHYSICIAN NOTICED THAT THERE WERE TINY FRAGMENTS SHEARING OFF OF THE STENT AND INTO THE PATIENT, WHILE REMOVING IT FROM THE WIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CONTOUR VL¿ STENT. DUE TO THE SIZE OF THE FRAGMENTS, THE FRAGMENTS WERE LEFT TO PASS ON THEIR OWN WITH NO PLANS FOR REMOVAL AT A LATER DATE. THE PATIENTS¿ CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7423388 ↗