Tria™ Soft M0061903210Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729959885), received between Nov 9, 2023 and Jan 21, 2026 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2026Break; Nonstandard Device

  IT WAS REPORTED THAT A TRIA URETERAL STENT WAS TO BE USED IN A RETROGRADE INTRARENAL SURGERY PROCEDURE. DURING UNPACKING, IT WAS FOUND THAT THE STENT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24127378 ↗
• MalfunctionJan 20, 2026Break; Nonstandard Device

  IT WAS REPORTED THAT A TRIA URETERAL STENT WAS TO BE USED IN A PROCEDURE. DURING UNPACKING, IT WAS FOUND THAT THE STENT WAS BROKEN. THERE WAS NO INFORMATION ON WHAT HAVE COMPLETED THE PROCEDURE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24126054 ↗
• MalfunctionAug 22, 2025Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS REPORTED THAT A TRIA URETERAL STENT WAS USED IN A URETEROSCOPY PROCEDURE. DURING THE PROCEDURE, IT WAS FOUND THAT THE STENT WAS BROKEN AND TORN BEFORE IMPLANTATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22874295 ↗
• InjuryAug 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHILE PLACING THE STENT BY THE PHYSICIAN A PIECE BROKE OFF. THE PHYSICIAN WAS ABLE TO RETRIEVE THE BROKEN PIECE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22731903 ↗
• MalfunctionNov 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A TRIA URETERAL STENT WAS USED DURING A RETROGRADE INTRARENAL SURGERY PROCEDURE AND DURING INSERTION, THE STENT COIL GOT DISCONNECTED WHEN UNFOLD. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20605283 ↗
• 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# 3005099803-2023-06002, MFR. REPORT# 3005099803-2023-06005 AND MFR. REPORT# 3005099803-2023-06007).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 18104987 ↗