Tria™ Firm M0061902120Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729937784), received between Nov 10, 2022 and Feb 3, 2026 — classified as 1 injury, 3 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.

• MalfunctionFeb 3, 2026Break; Nonstandard Device

  IT WAS REPORTED THAT PRIOR TO A RETROGRADE INTRARENAL SURGERY PROCEDURE, A TRIA URETERAL STENT WAS BROKEN DURING GUIDEWIRE INSERTION WHILE PREPARING FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24243457 ↗
• MalfunctionAug 4, 2025Break; Break

  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 HAD COMPLETED THE PROCEDURE AND THERE WERE NO KNOWN PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22708483 ↗
• MalfunctionJul 3, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING THE PREPARATION PRIOR TO PROCEDURE, THE PHYSICIAN OPENED A TRIA STENT AND HE OBSERVED THE DEVICE WAS KINKED. THE PROCEDURE WAS RESCHEDULED AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22401118 ↗
• InjuryNov 10, 2022Device Damaged by Another Device; Device-Device Incompatibility; Positioning Problem; Device Damaged by Another Device; Device-Device Incompatibility; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRIA URETERAL STENT WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE IN THE RIGHT KIDNEY AND PROXIMAL URETER PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE STENT RETROGRADE, HOWEVER, THE GUIDEWIRE WAS RETRACTED FOR ABOUT FOUR CENTIMETERS WHEN TRYING TO REMOVE. THEY USED FORCEPS AND A DORMIA BASKET TO PULL THE STENT AND PLACE IT CORRECTLY, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE ORIGINAL TRIA URETERAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED HOWEVER, AN ADDITIONAL INTERVENTION WAS REQUIRED. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "EXPECTED TO FULLY RECOVER".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15777072 ↗