Tria™ Soft M0061903240Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729959915), received between Jul 25, 2022 and Jun 16, 2025 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Unsealed Device Packaging” (3 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

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2025Unsealed Device Packaging; Adverse Event Without Identified Device or Use Problem; Unsealed Device Packaging; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TRIA URETERAL STENT WAS TO BE USED IN A PROCEDURE. DURING UNPACKING, IT WAS FOUND THAT THE INNER POUCH HAD A CUT FROM TOP TO BOTTOM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. NOTE: THIS REPORT PERTAINS TO ONE OF TWO TRIA URETERAL STENTS USED IN THE SAME PROCEDURE. REPORT # 2124215-2025-38648 AND REPORT# 2124215-2025-38649.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22215937 ↗
• MalfunctionJun 16, 2025Unsealed Device Packaging; Adverse Event Without Identified Device or Use Problem; Unsealed Device Packaging; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TRIA URETERAL STENT WAS TO BE USED IN A PROCEDURE. DURING UNPACKING, IT WAS FOUND THAT THE INNER POUCH HAD A CUT FROM TOP TO BOTTOM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. NOTE: THIS REPORT PERTAINS TO ONE OF TWO TRIA URETERAL STENTS USED IN THE SAME PROCEDURE. REPORT #: 2124215-2025-38648 AND REPORT #: 2124215-2025-38649.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22215532 ↗
• MalfunctionMay 27, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING THE URETEROSCOPY PROCEDURE, A TEAR WAS FOUND IN THE STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19400166 ↗
• MalfunctionMar 11, 2024Unsealed Device Packaging; Unsealed Device Packaging

  NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR REPORT # 2124215-2024-12870 AND MFR. REPORT # 2124215-2024-12880). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRIA SOFT URETERAL STENT WAS OPENED TO BE USED TO TREAT STONES DURING A URETEROSCOPY PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2024. PRIOR TO PROCEDURE, WHEN THE DEVICE WAS UNPACKED, IT WAS NOTED THAT THERE WAS SOME PROBLEM WITH THE PACKAGING. THE STENT WAS FOUND COMPROMISED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN ALTERNATIVE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18876987 ↗
• InjuryNov 9, 2023Calcified; Migration; Calcified; Migration

  NOTE: THIS REPORT IS ONE OF FIVE COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR REPORT# 3005099803-2023-05986, MFR. REPORT# 3005099803-2023-05990, MFR. REPORT# 3005099803-2023-06002, AND MFR. REPORT# 3005099803-2023-06005). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRIA SOFT URETERAL STENT WAS USED DURING A PROCEDURE. THE EVENT DATE WAS UNKNOWN. IT WAS NOTED THAT THE PHYSICIANS FOUND THAT THE TRIA SOFT URETERAL STENT HAD MIGRATED AND HAD SOME ENCRUSTATION ISSUES. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18106030 ↗
• MalfunctionMay 16, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A TRIA URETERAL STENT WAS TO BE USED DURING A URETEROSCOPY PROCEDURE, PERFORMED ON (B)(6) 2023. DURING UNPACKING, IT WAS FOUND THAT THE STENT WAS BROKEN INTO TWO PIECES. ANOTHER TRIA URETERAL STENT WAS OPENED AND USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16942990 ↗
• MalfunctionJul 25, 2022Break; Detachment of Device or Device Component; Material Split, Cut or Torn; Break; Detachment of Device or Device Component; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRIA URETERAL STENT WAS USED DURING A PROCEDURE. THE EVENT DATE IS UNKNOWN. DURING PREPARATION, THE STENT FELL APART WHEN THE PHYSICIAN ATTEMPTED TO USE IT. THE PROCEDURE WAS COMPLETED AND IT WAS UNKNOWN WHAT MODEL OF STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15099809 ↗