Contour™ SureDrive™ M0061458660Recalls & reported problems
Boston Scientific Corporation · Steerable Ureteral Stent Set · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729903215), received between Feb 3, 2023 and Feb 3, 2023 — classified as 1 injury.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hematuria1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
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 LEFT URETER PERFORMED ON (B)(6) 2022, AS PART OF THE U0652 DOUBLE-J REGISTRY CLINICAL STUDY. (B)(6) 2022, A PLANNED STENT REMOVAL PROCEDURE WAS PERFORMED. THE STENT WAS NOT DIFFICULT TO REMOVE AND WAS REMOVED SUCCESSFULLY. PAIN CONTROL WAS NOT REQUIRED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED MILD HEMATURIA AND MILD LEFT URETERAL PAIN AND WAS PRESCRIBED WITH KETOPROFEN FOR 48 HOURS AS MEDICATION FOR THE ADVERSE EVENTS. THE MILD HEMATURIA AND MILD URETERAL PAIN WERE REPORTED TO HAVE BEEN RESOLVED ON (B)(6) 2022. 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: Hematuria; Pain
MAUDE report 16300506 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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