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Tria™ Soft M0061903250Recalls & reported problems

Boston Scientific Corporation · Ureteral Stent · Class 2 · Implant

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 08714729953968), received between Apr 2, 2021 and Jun 5, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break2
  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 5, 2023Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A TRIA URETERAL STENT WAS OPENED TO BE USED IN AN UNSPECIFIED PROCEDURE ON AN UNKNOWN DATE. DURING PREPARATION, IT WAS NOTED THAT THE STENT WAS BROKEN INTO TWO PIECES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17060224 ↗
  • MalfunctionApr 2, 2021Break; Break

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRIA URETERAL STENT WAS USED DURING A URETEROSCOPY AND STENT PLACEMENT PROCEDURE IN THE KIDNEY, URETER, BLADDER, PERFORMED ON (B)(6) 2021. DURING UNPACKING, THE STENT BROKE IN TWO. ANOTHER TRIA URETERAL STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. 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 GOOD. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THAT THE STENT SHAFT WAS BROKEN IN TWO.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11607372 ↗

Other Stent, ureteral devices

All Stent, ureteral devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.