Ascerta™ M0061456140Recalls & reported problems
Boston Scientific Corporation · Ureteral Stent · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729802976), received between Mar 18, 2020 and Oct 18, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (2 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
Device problems
- Material Split, Cut or Torn2
- Device-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 18, 2022Device-Device Incompatibility; Material Split, Cut or Torn; Device-Device Incompatibility; Material Split, Cut or Torn
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ASCERTA URETERAL STENT WAS USED DURING A PERCUTANEOUS NEPHROLITHONOMY PROCEDURE IN THE KIDNEY, PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, WHEN THE SCRUB TECHNICIAN PULLED THE GUIDEWIRE OUT, THE GUIDEWIRE STARTED TO UNRAVEL CAUSING THE STENT TO TEAR. THE PROCEDURE WAS COMPLETED WITHOUT A STENT IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15621049 ↗MalfunctionMar 18, 2020Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ASCERTA URETERAL STENT WAS USED DURING A URETEROSCOPY WITH LASER LITHOTRIPSY AND STENT PLACEMENT PROCEDURE IN THE KIDNEY, URETER AND BLADDER, PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, INSIDE THE PATIENT, WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE SUTURE, THE SUTURE WAS BROKEN AND IT RIPPED THE STENT FORMING A SMALL TEAR IN THE COIL. REPORTEDLY, A VISIBLE HOLE IN THE BOTTOM PART OF THE COIL WAS NOTICED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER ASCERTA URETERAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9848931 ↗
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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