Contour™ M0061802230Recalls & reported problems

Summary

The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 08714729058533), received between Mar 21, 2017 and Sep 23, 2026 — classified as 5 injuries, 65 malfunctions.

The most frequently reported specific device problem is “Break” (28 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 25 most recent of 70 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Material Split, Cut or Torn

  It was reported that a Contour Stent was used in a urological procedure. During procedure, it was found that there was a tear at the tip of the product. 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 50864397 ↗
• MalfunctionSep 9, 2026Break

  It was reported that a contour ureteral stent was used during calculus procedure. During procedure, the stent was fractured. The procedure was completed with another of the same stent. there were no patient complications as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50684446 ↗
• MalfunctionJun 8, 2026Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT A CONTOUR URETERAL STENT WAS USED IN A URETEROSCOPY PROCEDURE IN THE KIDNEY. DURING THE PROCEDURE, IT WAS NOTICED THAT THE STENT WOULD NOT PASS OVER THE WIRE AND WAS 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 25429741 ↗
• MalfunctionFeb 11, 2026Break; Nonstandard Device

  IT WAS REPORTED THAT A CONTOUR URETERAL STENT WAS USED IN A TRANSURETHRAL URETEROSCOPIC HOLMIUM LASER LITHOTRIPSY PROCEDURE IN THE KIDNEY. DURING THE PROCEDURE AND INSIDE THE PATIENT, IT WAS NOTICED THAT THE STENT 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 24319044 ↗
• MalfunctionJan 16, 2026Material Deformation

  IT WAS REPORTED THAT A CONTOUR URETERAL STENT WAS USED IN A URETERAL STENT PLACEMENT PROCEDURE IN THE URETER. DURING INSERTION AND INSIDE THE PATIENT, IT WAS NOTICED THAT THE STENT GOT DEFORMED. 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 24101182 ↗
• MalfunctionJan 6, 2026Break

  IT WAS REPORTED THAT A CONTOUR URETERAL STENT WAS TO BE USED IN A URETEROLITHOTRIPSY PROCEDURE. DURING UNPACKING, IT WAS FOUND THAT THE STENT 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 23983538 ↗
• MalfunctionDec 23, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT, A CONTOUR URETERAL STENT WAS TO BE USED FOR A URETEROLITHOTRIPSY PROCEDURE, WHEN THE DEVICE WAS UNPACKED, IT WAS FOUND THAT THE STENT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23874662 ↗
• MalfunctionNov 26, 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 IN A URETERAL STENT IMPLANTATION SURGERY PROCEDURE IN THE URETER. DURING THE PROCEDURE, THE STENT COULD NOT BE ADVANCED SMOOTHLY, AND WHEN REMOVED, IT WAS NOTICED THE STENT WAS SPLIT AT ONE END. 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 23659789 ↗
• MalfunctionNov 21, 2025Nonstandard Device; Material Deformation; Nonstandard Device; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR STENT DEVICE WAS USED UNDER LOCAL ANESTHESIA DURING A CYSTOSCOPY PROCEDURE. DURING INSERTION, THE STENT BECAME DISTORTED AND COULD NOT BE SUCCESSFULLY INSERTED. A NEW STENT WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23624806 ↗
• MalfunctionNov 13, 2025Break; Break

  IT WAS REPORTED THAT, DURING UNPACKING, WHEN THE PHYSICIAN PREPARED TO USE THE STENT FOR THE PATIENT, THE STENT SUDDENLY FRACTURED AND COULD NOT BE USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23548877 ↗
• MalfunctionOct 15, 2025Break; Nonstandard Device; Break

  IT WAS REPORTED THAT DURING UNPACKING, IT WAS FOUND THAT THE DEVICE WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23295298 ↗
• MalfunctionSep 5, 2025Break; Break

  IT WAS REPORTED THAT DURING UNPACKING; THE STENT FRACTURED INTO TWO PIECES AT THE BLADDER END. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22986957 ↗
• MalfunctionAug 26, 2025Calcified; Calcified

  IT WAS REPORTED THAT A CONTOUR URETERAL STENT WAS IMPLANTED INTO THE PATIENT. A MONTH LATER, FOLLOWING THE PROCEDURE, A STENT REMOVAL PROCEDURE WAS PERFORMED, AND IT WAS FOUND THAT THE STENT'S WALL WAS ENCRUSTED BUT WAS STILL ABLE TO DRAIN. THE STENT WAS COMPLETELY REMOVED UNDER INTRAVENOUS ANESTHESIA AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WAS NO NEW STENT IMPLANTED AND THERE WERE NO KNOWN PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22893779 ↗
• MalfunctionFeb 5, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING PREPARATION, THE NURSE FOUND THAT THE URETERAL 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 21318082 ↗
• MalfunctionJan 8, 2025Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CONTOUR URETERAL STENT WAS USED DURING A URETEROLITHOTRIPSY PROCEDURE, AND, DURING THE PROCEDURE, WHEN THE DEVICE WAS INSERTED INSIDE THE PATIENT, IT WAS NOTED THAT THE STENT HAD WRINKLES AND COULD NOT BE INSERTED ANY FURTHER. 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 21106896 ↗
• MalfunctionDec 2, 2024Deformation Due to Compressive Stress; Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Deformation Due to Compressive Stress; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING A LITHOTRIPSY FOR LEFT URETERAL CALCULI PROCEDURE A CONTOUR URETERAL STENT WAS USED. WHEN THE STENT WAS INSERTED, THE STENT WAS WRINKLED AND COULD NOT BE INSERTED INTO THE URETER SMOOTHLY. ANOTHER OF THE SAME STENT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20824702 ↗
• MalfunctionNov 27, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT A CONTOUR URETERAL STENT WAS GOING TO BE USED, DURING PARING PREPARATION, IT WAS REPORTED THAT THE STENT COIL WAS DETACHED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20801276 ↗
• MalfunctionNov 27, 2024Deformation Due to Compressive Stress; Device-Device Incompatibility; Difficult to Advance; Deformation Due to Compressive Stress; Device-Device Incompatibility; Difficult to Advance

  IT WAS REPORTED THAT, DURING THE PROCEDURE A CONTOUR URETERAL STENT WAS USED, WHEN THE STENT WAS INSERTED, IT BECAME BUNCHED UP ON THE WIRE AND WOULD NOT ADVANCE INTO PLACE. ANOTHER OF A DIFFERENT LOT WAS OPENED AND IT WAS INSERTED INTO THE URETER WITHOUT ANY DIFFICULTY. WHEN ATTEMPTED TO PLACE THE STENT ON THE RIGHT SIDE, THE STENT BECAME BUNCHED AGAIN. NO PATIENT COMPLICATIONS WERE REPORTED. THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR REPORT # 2124215-2024-74908 AND MFR. REPORT # 02670000-2024-8010).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20798016 ↗
• MalfunctionNov 27, 2024Deformation Due to Compressive Stress; Device-Device Incompatibility; Difficult to Advance; Deformation Due to Compressive Stress; Device-Device Incompatibility; Difficult to Advance

  IT WAS REPORTED THAT, DURING THE PROCEDURE A CONTOUR URETERAL STENT WAS USED, WHEN THE STENT WAS INSERTED, IT BECAME BUNCHED UP ON THE WIRE AND WOULD NOT ADVANCE INTO PLACE. ANOTHER OF A DIFFERENT LOT WAS OPENED AND IT WAS INSERTED INTO THE URETER WITHOUT ANY DIFFICULTY. WHEN ATTEMPTED TO PLACE THE STENT ON THE RIGHT SIDE, THE STENT BECAME BUNCHED AGAIN. NO PATIENT COMPLICATIONS WERE REPORTED. THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR. REPORT # (B)(4)).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20797680 ↗
• MalfunctionNov 26, 2024Deformation Due to Compressive Stress; Device-Device Incompatibility; Difficult to Advance; Deformation Due to Compressive Stress; Device-Device Incompatibility; Difficult to Advance

  IT WAS REPORTED THAT, DURING THE URETEROSCOPY PROCEDURE A CONTOUR URETERAL STENT WAS USED, THE STENT BECAME ACCORDIONED OVER THE WIRE MAKING IT DIFFICULT TO PLACE; HOWEVER, THE STENT WAS SUCCESSFULLY IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20789090 ↗
• InjuryNov 20, 2024Migration; Migration

  IT WAS REPORTED THAT THE PATIENT WENT TO THE HOSPITAL ON (B)(6) 2024 WITH LEFT LUMBAR AND ABDOMINAL PAIN FOR ONE DAY. THE PATIENT UNDERWENT TRANSURETHRAL HOLMIUM LASER LITHOTOMY OF THE LOWER LEFT URETER UNDER COMBINED LUMBAR AND EPIDURAL ANESTHESIA ON (B)(6) 2024. A 6F URETERAL STET WAS INDWELLED AFTER THE OPERATION. ON (B)(6) 2024, IT WAS NOTED THAT THE URETERAL STENT WAS DISPLACED, AND BLOOD WAS PRESENT IN THE PATIENT'S URINE. THE PATIENT WAS RESTENTED AND GIVEN A HEMOSTATIC TREATMENT WITH INJECTABLE SODIUM CARBOXYSULFONE. ON (B)(6) 2024 THE PATIENT WAS HEMATURIA FREE, AND THEIR SYMPTOMS HAD RESOLVED.

  Patient problems: Abdominal Pain; Hematuria

  MAUDE report 20737929 ↗
• MalfunctionAug 2, 2024Use of Device Problem; Deformation Due to Compressive Stress; Device-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Deformation Due to Compressive Stress; Device-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE, WHEN THE PHYSICIAN PLACED THE CONTOUR URETERAL STENT OVER A SENSOR WIRE, THE STENT WAS STUCK ONTO THE SENSOR WIRE AND BECAME BUCKLED. THE PHYSICIAN HAD TO CUT THE STENT AND WIRE TO BE REMOVED. REPORTEDLY, THE GUIDEWIRE WAS ADVANCE IN AND OUT OF THE URETHRA THAT MIGHT HAVE CAUSED THE GUIDEWIRE TO BECOME FRAYED WHEN IT WAS CLAMPED AND LEADING THE STENT TO BE STUCK ONTO THE GUIDEWIRE. ANOTHER OF THE SAME STENT AND GUIDEWIRE WERE USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19898352 ↗
• MalfunctionApr 5, 2024Deformation Due to Compressive Stress; Difficult to Advance; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR URETERAL STENT WAS USED DURING A URETEROSCOPY PROCEDURE IN THE URETER AND KIDNEY PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHEN ATTEMPTED TO PLACE THE STENT IN THE URETER, IT WAS NOTED THAT IT KEPT COILING ON THE GUIDEWIRE. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 19056055 ↗
• MalfunctionJan 17, 2024Difficult to Advance; Material Split, Cut or Torn; Difficult to Advance; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR URETERAL STENT WAS USED TO TREAT STONES DURING A URETERAL LITHOTRIPSY PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THEY COULD NOT IMPLANT THE STENT AFTER SEVERAL ATTEMPTS. IT WAS FOUND THAT THE STENT HAD A CRACK AND WAS FOLDED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER CONTOUR 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. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THAT THE STENT WAS TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18524346 ↗
• MalfunctionDec 29, 2023Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR URETERAL STENT WAS USED DURING A URETERAL LITHOTRIPSY PROCEDURE IN THE URETHRA PERFORMED ON (B)(6) 2023. DURING INSERTION, IT WAS NOTED THAT THE STENT COULD NOT BE DELIVERED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER CONTOUR 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 WAS BUCKLED/ACCORDIONED, 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 18419092 ↗