Contour™ M0061802210Recalls & reported problems
Boston Scientific Corporation · Ureteral Stent · Class 2 · Implant
All models of Contour (14)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729058472), received between Aug 13, 2018 and Feb 23, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break1
- Material Split, Cut or Torn1
- Unsealed Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 23, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT A CONTOUR URETERAL STENT WAS USED IN A URETEROSCOPIC LITHOTRIPSY PROCEDURE IN THE URETER. DURING PROCEDURE AND INSIDE THE PATIENT, THE STENT WAS FOUND UNUSABLE DUE TO SUSPECTED COATING DETACHMENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24416510 ↗MalfunctionMar 16, 2020Unsealed Device Packaging; Unsealed Device Packaging
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN CONTOUR URETERAL STENT WAS USED DURING AN URETEROSCOPY W/ STENT PLACEMENT PROCEDURE IN THE KIDNEY, URETER AND BLADDER, PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, WHEN THE CIRCULATING NURSE WAS UNPACKING THE OUTER BOX, THE WRAPPER TORE ACROSS THE PACKAGE AND ACCIDENTALLY TORE THE STERILE POUCH COMPROMISING THE STERILITY OF THE DEVICE. ANOTHER CONTOUR URETERAL STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9836405 ↗MalfunctionAug 13, 2018Break
AS STAFF WAS OPENING STENT TO PUT ON STERILE TABLE, STENT BROKE AND WAS REMOVED. OPERATING ROOM STAFF WAS OPENING STENT TO PUT ON STERILE FIELD. STENT DID NOT TOUCH PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7776834 ↗
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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