Tria™ Firm M0061902320Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729937906), received between Aug 19, 2022 and Apr 14, 2026 — classified as 4 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2026Break; Nonstandard Device

  IT WAS REPORTED THAT DURING A RETROGRADE INTRARENAL SURGERY PROCEDURE A TRIA URETERAL STENT WAS INTENDED TO BE USED; HOWEVER, IT WAS FOUND THAT THE STENT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24879262 ↗
• MalfunctionSep 5, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE END OF THE PRODUCT CRUMPLED AND DOES NOT GO IN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO KNOWN PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22982321 ↗
• MalfunctionJul 31, 2025Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PREPARATION, AFTER UNPACKING, BEFORE USE, WHEN IT WAS PULLED, IT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22682682 ↗
• MalfunctionAug 19, 2022Difficult to Advance; Material Deformation; Material Integrity Problem; Difficult to Advance; Material Deformation; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRIA FIRM UERERAL STENT WAS USED DURING A URETEROSCOPY PROCEDURE IN THE LEFT URETER, PERFORMED ON (B)(6)2022. DURING THE PROCEDURE, THE STENT COULD NOT BE INSERTED IN THE URETER. IT WAS NOTICED THAT THE LUMEN IS NOT IN NORMAL CONDITION. ANOTHER TRIA FIRM URETERAL STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF STENT KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15261813 ↗