Tria™ Firm M0061902420Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729937968), received between Jul 15, 2019 and Jun 21, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Calcified” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 21, 2024Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT, DURING A URETERORENOSCOPY PROCEDURE USING A TRIA URETERAL STENT, THE COSMETIC OF THE STENT AT THE BLADDER SIDE WAS DAMAGED, INSIDE THE PATIENT. ANOTHER OF THE SAME STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19584768 ↗
• MalfunctionJul 16, 2019Calcified; Obstruction of Flow; Calcified; Obstruction of Flow

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRIA URETERAL STENT WAS USED DURING A PROCEDURE IN THE URETER. ACCORDING TO THE COMPLAINANT, 10 WEEKS AFTER THE PROCEDURE, ON (B)(6) 2019, A URETERAL STENT REMOVAL WAS PERFORMED AND THE PHYSICIAN NOTICED THAT THE STENT WAS OCCLUDED/BLOCKED. THE BLOCKED STENT WAS REPORTEDLY ABLE TO DRAIN. THE ENTIRE STENT WAS REMOVED WITH THE USE OF FORCEPS AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO SERIOUS INJURY, NOR WERE THERE ANY ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8795126 ↗
• MalfunctionJul 15, 2019Calcified; Obstruction of Flow; Calcified; Obstruction of Flow

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PREVIOUSLY IMPLANTED TRIA URETERAL STENT WAS USED REMOVED FROM A PATIENT DURING URETERAL STENT REMOVAL PROCEDURE PERFORMED IN THE URETER ON (B)(6) 2019. THE EXACT IMPLANT DATE WAS NOT PROVIDED. ACCORDING TO THE COMPLAINANT, THE STENT WAS IMPLANTED FOR 10 WEEKS AND WAS EXPLANTED ON (B)(6) 2019, WHEN THE PLANNED STENT REMOVAL PROCEDURE WAS PERFORMED DUE TO THE PERIODIC REPLACEMENT, THE STENT WAS FOUND TO HAVE BLACK DISCOLORATION IN THE BLADDER SIDE AND KIDNEY. IT WAS NOTICED THAT THE STENT WAS CALCIFIED AROUND THE BLADDER SIDE AND WAS OCCLUDED, HOWEVER THE STENT WAS ABLE TO DRAIN. REPORTEDLY, THE PHYSICIAN HAD TO CUT THE BLADDER SIDE OF THE STENT AND USED FORCEPS TO REMOVE THE STENT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NON BSC PRODUCT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8789854 ↗