Contour™ SureDrive™ M0061458630Recalls & reported problems
Boston Scientific Corporation · Steerable Ureteral Stent Set · Class 2 · Implant
Data updated Oct 13, 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 08714729903185), received between Nov 30, 2022 and Nov 30, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Calcified” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Calcified1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 30, 2022Calcified; Calcified
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PREVIOUSLY IMPLANTED CONTOUR URETERAL STENT WAS REMOVED FROM THE LEFT URETER, PERFORMED ON (B)(6) 2022, AS A PART OF THE U0652 DOUBLE-J REGISTRY CLINICAL STUDY. THE CONTOUR URETERAL STENT WAS PLACED RETROGRADE ON THE LEFT SIDE UNDER FLUOROSCOPY AND CYSTOSCOPY ON (B)(6) 2022, WITH NO PROBLEMS REPORTED DURING PLACEMENT. ON (B)(6) 2022, THE PATIENT HAD A LEFT RENAL LITHIASIS AND WAS HOSPITALIZED UNDER URETERAL INTERVENTIONAL PROCEDURE UNTIL (B)(6) 2022. ON (B)(6) 2022, THE CONTOUR URETERAL STENT WAS SUCCESSFULLY REMOVED FROM THE PATIENT IN THE OPERATING ROOM. NO ISSUES WERE REPORTED WITH THE DEVICE DURING REMOVAL. THE PATIENT WAS GIVEN A MEDICATION OF MORPHINE 10 MG/ML, KETOPROFEN 100 MG/4ML. ON (B)(6) 2022, THE EVENT WAS CONSIDERED RESOLVED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Pain
MAUDE report 15890299 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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