ContourRecalls & reported problems across all models

We found 14 models of Contour by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 121 adverse event reports in the FDA's MAUDE database, received between Mar 21, 2017 and Sep 23, 2026 — classified as 15 injuries, 106 malfunctions.

The most frequently reported specific device problem is “Break” (46 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Contour problems

Contour models

14 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Contour™ M0061802230

  STENT, URETERAL
  70 reports
• Contour™ M0061802220

  STENT, URETERAL
  26 reports
• Contour™ M0061802240

  STENT, URETERAL
  9 reports
• Contour™ M0061802210

  STENT, URETERAL
  3 reports
• Contour™ M0061802310

  STENT, URETERAL
  2 reports
• Contour™ M0061802440

  STENT, URETERAL
  2 reports
• Contour™ M006180522180

  STENT, URETERAL
  2 reports
• Contour™ M006180223010

  STENT, URETERAL
  1 report
• Contour™ M0061802320

  STENT, URETERAL
  1 report
• Contour™ M0061802330

  STENT, URETERAL
  1 report
• Contour™ M0061802340

  STENT, URETERAL
  1 report
• Contour™ M0061805310

  STENT, URETERAL
  1 report
• Contour™ M0061805320

  STENT, URETERAL
  1 report
• Contour™ M006180223090

  STENT, URETERAL
  1 report

Recent Contour adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionSep 9, 2026Deformation Due to Compressive Stress

  It was reported that a Contour Ureteral stent was used in a ureteroscopy with laser lithotripsy and stent exchange procedure. During the procedure, when the physician placed stent over wire it was noticed some buckling on the screen. The procedure was completed with the same device.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50683474 ↗
• MalfunctionAug 25, 2026Detachment of Device or Device Component

  It was reported that a Contour Ureteral Stent was used during a Ureteroscopy. During the procedure, it was noticed that the tip of the stent broke off. 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 50425863 ↗
• 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 ↗
• MalfunctionMay 20, 2026Break; Difficult to Advance

  IT WAS REPORTED THAT, DURING THE REMOVAL OF KIDNEY STONES PROCEDURE, A CONTOUR URETERAL STENT WAS INTENDED TO BE USED. UPON UNPACKING, IT WAS FOUND THAT THE FRONT END OF THE STENT ADHERED AND THE MIDDLE PART 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 25226481 ↗
• MalfunctionApr 29, 2026Break; Material Deformation

  IT WAS REPORTED THAT A CONTOUR URETERAL STENT WAS TO BE USED IN A PROCEDURE. DURING UNPACKING, IT WAS FOUND THAT THE END OF THE STENT WAS BENT. 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 25034501 ↗
• MalfunctionApr 29, 2026Break; Material Deformation

  IT WAS REPORTED THAT A CONTOUR URETERAL STENT WAS TO BE USED IN A PROCEDURE. DURING UNPACKING, IT WAS FOUND THAT THE END OF THE STENT WAS BENT. 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 25032966 ↗
• MalfunctionApr 22, 2026Break; Material Deformation

  IT WAS REPORTED THAT A CONTOUR URETERAL STENT WAS TO BE USED IN A PROCEDURE. DURING UNPACKING, IT WAS FOUND THAT THE FRONT END OF THE PRODUCT WAS ADHERED AND THE MIDDLE PART 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 24960862 ↗
• MalfunctionApr 14, 2026Break

  IT WAS REPORTED THAT A CONTOUR URETERAL STENT WAS TO BE USED IN A PROCEDURE. DURING UNPACKING, IT WAS FOUND THAT THE STENT WAS FRACTURED INTO TWO PARTS. 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 24877254 ↗
• MalfunctionFeb 23, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT A CONTOUR URETERAL STENT WAS USED IN A URETEROSCOPIC LITHOTRIPSY PROCEDURE IN THE URETER. DURING PROCEDURE AND INSIDE THE PATIENT, THE STENT WAS FOUND UNUSABLE DUE TO SUSPECTED COATING DETACHMENT. 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 24416510 ↗
• 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 ↗

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