Contour™ SureDrive™ M0061458670Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729903222), received between Feb 3, 2023 and Jan 16, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A CONTOUR URETERAL STENT WAS USED STENT PLACEMENT PROCEDURE IN THE BLADDER AND URETHRA. DURING PROCEDURE CLOSURE, IT WAS NOTICED THAT THERE WERE ORANGE PIECES FROM THE PUSHER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24103099 ↗
• MalfunctionAug 7, 2025Difficult to Remove; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CONTOUR URETERAL STENT WAS IMPLANTED INTO THE PATIENT. POST PROCEDURE, A STENT REMOVAL WAS PERFORMED AND DURING THE PROCEDURE, THERE WAS DIFFICULTY IN REMOVING THE STENT AND IT WAS NOTICED THAT THE BLADDER COIL BROKE. THERE WAS NO INFORMATION ON WHAT DEVICE HAVE COMPLETED THE PROCEDURE. THE PATIENT HAD EXPERIENCED BLEEDING DURING THE PROCEDURE. NO OTHER COMPLICATIONS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22745836 ↗
• InjuryFeb 3, 2023Adverse 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 URETERAL STENT WAS USED IN A STENT PLACEMENT PROCEDURE FOR STONE MANAGEMENT; LASER LITHOTRIPSY IN THE RIGHT URETER PERFORMED ON (B)(6) 2022. THE PATIENT UNDERWENT THE STUDY ON (B)(6) 2022, AS PART OF THE U0652 DOUBLE-J REGISTRY CLINICAL STUDY. POST PROCEDURE, ON (B)(6) 2022, A PLANNED STENT REMOVAL PROCEDURE WAS PERFORMED. THE STENT WAS NOT DIFFICULT TO REMOVE AND WAS REMOVED SUCCESSFULLY. PAIN CONTROL WAS REQUIRED. IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT EXPERIENCED MILD IRRITATIVE MICTIONAL DISORDER AND WAS GIVEN A TREATMENT PLAN OF ALLERGIC INTERSTITIAL NEPHRITIS (AINS) DISCONTINUATION AND ONGOING DIURESIS ON (B)(6) 2022. THE MILD IRRITATIVE MICTIONAL DISORDER WAS REPORTED TO HAVE NOT BEEN RESOLVED. IN THE PHYSICIAN'S ASSESSMENT, THE RELATIONSHIP BETWEEN THE PROCEDURE AND THE EVENT IS POSSIBLY RELATED, AND THE RELATIONSHIP BETWEEN THE DEVICE AND THE EVENT IS POSSIBLY RELATED.

  Patient problems: Micturition Urgency

  MAUDE report 16300688 ↗