Contour™ SureDrive™ M0061458620Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729903178), received between Dec 11, 2017 and Dec 26, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Bent” (3 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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 26, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT, DURING A FLEXIBLE URETEROSCOPY PROCEDURE, A CONTOUR URETERAL STENT WAS USED. WHEN THE DOUBLE J STENT WAS PLACED, THE CATHETER PUSHER MUST BE REMOVED; HOWEVER, IT REMAINED STUCK IN THE STENT, WHICH CAUSED THE CATHETER TO BE REMOVED AT THE SAME TIME THE PUSHER. THE STENT WAS UNABLE TO BE PLACED AT THE END OF THE PROCEDURE. IT WAS NOT POSSIBLE TO RETRY THE IMPLANT. WITHOUT A STENT, THERE IS A RISK OF RENAL COLIC. NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21021161 ↗
• MalfunctionDec 12, 2017Bent; Kinked; Bent; Kinked

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SUREDRIVE TM WAS REMOVED IN A URETERAL STENT REMOVAL PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, THE STENT WAS PREVIOUSLY IMPLANTED IN OCTOBER. THE EXACT DATE OF IMPLANTATION IS UNKNOWN. WHEN REMOVAL WAS STARTED, THE PHYSICIAN NOTICED THAT THE KIDNEY SIDE COIL WAS NOT DEPLOYED STRAIGHT AND IT WAS PULLED OUT IN U-SHAPE. THE STENT WAS COMPLETELY REMOVED BY BEING GRASPED WITH FORCEPS UNDER CYSTOSCOPE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7107945 ↗
• MalfunctionDec 11, 2017Bent; Kinked; Bent; Kinked

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SUREDRIVE TM WAS REMOVED IN A URETERAL STENT REMOVAL PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, THE STENT WAS PREVIOUSLY IMPLANTED IN (B)(6). THE EXACT DATE OF IMPLANTATION IS UNKNOWN. WHEN REMOVAL WAS STARTED, THE PHYSICIAN NOTICED THAT THE KIDNEY SIDE COIL WAS NOT DEPLOYED STRAIGHT AND IT WAS PULLED OUT IN U-SHAPE. THE STENT WAS COMPLETELY REMOVED BY BEING GRASPED WITH FORCEPS UNDER CYSTOSCOPE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7105254 ↗
• MalfunctionDec 11, 2017Bent; Kinked; Bent; Kinked

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SUREDRIVE TM WAS REMOVED IN A URETERAL STENT REMOVAL PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, THE STENT WAS PREVIOUSLY IMPLANTED IN (B)(6). THE EXACT DATE OF IMPLANTATION IS UNKNOWN. WHEN REMOVAL WAS STARTED, THE PHYSICIAN NOTICED THAT THE KIDNEY SIDE COIL WAS NOT DEPLOYED STRAIGHT AND IT WAS PULLED OUT IN U-SHAPE. THE STENT WAS COMPLETELY REMOVED BY BEING GRASPED WITH FORCEPS UNDER CYSTOSCOPE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7104021 ↗