Contour™ SureDrive™ M0061458610Recalls & reported problems
Boston Scientific Corporation · Steerable Ureteral Stent Set · Class 2 · Implant
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729903161), received between Nov 16, 2017 and Nov 17, 2017 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Calcified” (9 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
Device problems
- Calcified9
Patient problems
- No Known Impact Or Consequence To Patient9
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 17, 2017Calcified; Calcified
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SUREDRIVE TM WAS USED FOR AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, POST PROCEDURE, IT WAS NOTICED THAT THE STENT WAS CALCIFIED INSIDE THE PATIENT. 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 Known Impact Or Consequence To Patient
MAUDE report 7041588 ↗MalfunctionNov 17, 2017Calcified; Calcified
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SUREDRIVE TM WAS USED FOR AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, POST PROCEDURE, IT WAS NOTICED THAT THE STENT WAS CALCIFIED INSIDE THE PATIENT. 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 Known Impact Or Consequence To Patient
MAUDE report 7040572 ↗MalfunctionNov 17, 2017Calcified; Calcified
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SUREDRIVE TM WAS USED FOR AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, POST PROCEDURE, IT WAS NOTICED THAT THE STENT WAS CALCIFIED INSIDE THE PATIENT. 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 Known Impact Or Consequence To Patient
MAUDE report 7040541 ↗MalfunctionNov 17, 2017Calcified; Calcified
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SUREDRIVE TM WAS USED FOR AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, POST PROCEDURE, IT WAS NOTICED THAT THE STENT WAS CALCIFIED INSIDE THE PATIENT. 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 Known Impact Or Consequence To Patient
MAUDE report 7040519 ↗MalfunctionNov 17, 2017Calcified; Calcified
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SUREDRIVE TM WAS USED FOR AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, POST PROCEDURE, IT WAS NOTICED THAT THE STENT WAS CALCIFIED INSIDE THE PATIENT. 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 Known Impact Or Consequence To Patient
MAUDE report 7040509 ↗MalfunctionNov 16, 2017Calcified; Calcified
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SUREDRIVE TM WAS USED FOR AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, POST PROCEDURE, IT WAS NOTICED THAT THE STENT WAS CALCIFIED INSIDE THE PATIENT. 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 Known Impact Or Consequence To Patient
MAUDE report 7039553 ↗MalfunctionNov 16, 2017Calcified; Calcified
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SUREDRIVE TM WAS USED FOR AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, POST PROCEDURE, IT WAS NOTICED THAT THE STENT WAS CALCIFIED INSIDE THE PATIENT. 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 Known Impact Or Consequence To Patient
MAUDE report 7039479 ↗MalfunctionNov 16, 2017Calcified; Calcified
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SUREDRIVE TM WAS USED FOR AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, POST PROCEDURE, IT WAS NOTICED THAT THE STENT WAS CALCIFIED INSIDE THE PATIENT. 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 Known Impact Or Consequence To Patient
MAUDE report 7039463 ↗MalfunctionNov 16, 2017Calcified; Calcified
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SUREDRIVE TM WAS USED FOR AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, POST PROCEDURE, IT WAS NOTICED THAT THE STENT WAS CALCIFIED INSIDE THE PATIENT. 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 Known Impact Or Consequence To Patient
MAUDE report 7039459 ↗
Other STENT, URETERAL devices
- Bard® InLay Optima® Ureteral Stent 788426C. R. Bard, Inc. · STENT, URETERAL1 recall100 reports
- Bard® InLay Optima® Ureteral Stent 788626C. R. Bard, Inc. · STENT, URETERAL122 reports
- Bard® InLay® Ureteral Stent with HydroGlide™ Guidewire 777626C. R. Bard, Inc. · STENT, URETERAL118 reports
- Bard® InLay® Ureteral Stent with HydroGlide™ Guidewire 777426C. R. Bard, Inc. · STENT, URETERAL108 reports
- Bard® InLay® Ureteral Stent 778626C. R. Bard, Inc. · STENT, URETERAL100 reports
- Percuflex™ Plus M0061752530Boston Scientific Corporation · STENT, URETERAL1 death99 reports
- Contour VL™ M0061801560Boston Scientific Corporation · STENT, URETERAL1 recall45 reports
- Polaris™ Ultra M0061921330Boston Scientific Corporation · STENT, URETERAL71 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.