Ascerta™ Firm M0061456470Recalls & reported problems
Boston Scientific Corporation · Ureteral Stent · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729861782), received between Sep 5, 2025 and Sep 5, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Difficult to Remove” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Difficult to Remove2
- Material Integrity Problem2
Patient problems
- Foreign Body In Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 5, 2025Difficult to Remove; Material Integrity Problem; Difficult to Remove; Material Integrity Problem
IT WAS REPORTED THAT AN ASCERTA FIRM URETERAL STENT WAS IMPLANTED INTO THE KIDNEY OF THE PATIENT. FOLLOWING THE PROCEDURE, A URETEROSCOPY FOR STENT REMOVAL PROCEDURE WAS PERFORMED, AND IT WAS NOTICED THAT THE RENAL COIL WOULD NOT UNWIND, RESULTING TO THE DEVICE BEING PARTIALLY EXPLANTED AND A PORTION OF THE STENT REMAINS IMPLANTED. ANOTHER URETEROSCOPY PROCEDURE WAS SCHEDULED TO REMOVE THE UNRETRIEVED FRAGMENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT IS ALSO BEING REPORTED FOR CANCELLED/RESCHEDULED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION STATUS UNKNOWN.
Patient problems: Foreign Body In Patient
MAUDE report 22980704 ↗InjurySep 5, 2025Difficult to Remove; Material Integrity Problem; Difficult to Remove; Material Integrity Problem
IT WAS REPORTED THAT AN ASCERTA FIRM URETERAL STENT WAS IMPLANTED INTO THE KIDNEY OF THE PATIENT. FOLLOWING THE PROCEDURE, A URETEROSCOPY FOR STENT REMOVAL PROCEDURE WAS PERFORMED, AND IT WAS NOTICED THAT THE RENAL COIL WOULD NOT UNWIND, RESULTING TO THE DEVICE BEING PARTIALLY EXPLANTED AND A PORTION OF THE STENT REMAINS IMPLANTED. ANOTHER URETEROSCOPY PROCEDURE WAS SCHEDULED TO REMOVE THE UNRETRIEVED FRAGMENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT IS ALSO BEING REPORTED FOR CANCELLED/RESCHEDULED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION STATUS UNKNOWN.
Patient problems: Foreign Body In Patient
MAUDE report 22980046 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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