Tria™ Firm M0061902220Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08714729937845), received between Aug 2, 2019 and Apr 28, 2025 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2025Break; Break

  IT WAS REPORTED THAT DURING THE PREPARATION, WHILE REMOVING THE SUTURE FROM THE STENT PRIOR TO PLACING IT IN THE PATIENT, IT CAUSED THE END OF THE STENT TO SNAP/BREAK OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21921956 ↗
• MalfunctionApr 22, 2025Break; Break

  IT WAS REPORTED THAT A TRIA URETERAL STENT WAS USED IN A PROCEDURE. DURING THE PROCEDURE, IT WAS NOTICED 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 21879054 ↗
• MalfunctionMar 21, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PREPARATION, AFTER REMOVING THE PACKAGING, THE STENT WAS BROKEN WHEN THE THREAD WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THE PATIENT CONDITION WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21665693 ↗
• MalfunctionJul 8, 2024Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT, DURING UNPACKING, THE SEAL OF THE TRIA URETERAL STENT PACKAGING WAS TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19697495 ↗
• MalfunctionSep 14, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRIA FIRM URETERAL STENT WAS ATTEMPTED TO BE USED DURING A STENT REPLACEMENT PROCEDURE. THE EXACT EVENT DATE WAS NOT PROVIDED. DURING THE PROCEDURE, THE STENT WAS FOUND FRACTURED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER TRIA FIRM URETERAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE AS NO PATIENT INJURY. 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 17749444 ↗
• MalfunctionMay 5, 2023Break; Break

  IT WAS REPORTED A TRIA FIRM URETERAL STENT WAS USED DURING A STENT REPLACEMENT PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE STENT WAS SEPARATED WHEN REMOVING THE SUTURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER TRIA FIRM URETERAL STENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16878085 ↗
• MalfunctionNov 16, 2022Calcified; Difficult to Remove; Calcified; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRIA URETERAL STENT WAS USED IN A STENT PLACEMENT PROCEDURE FOR MALIGNANT OBSTRUCTION IN THE LEFT URETER PERFORMED ON (B)(6) 2022, AS PART OF THE U0652 DOUBLE-J REGISTRY CLINICAL STUDY. THE SUBJECT WAS PRE-STENTED ON (B)(6) 2021 WHICH WAS REMOVED ON (B)(6) 2022, AND A NEW TRIA URETERAL STENT WAS PLACED RETROGRADE ON THE LEFT URETER UNDER CYSTOSCOPY. THE STENT WAS SUCCESSFULLY IMPLANTED UNDER THE DIRECTION FOR USE AND WAS PERFORMED WITHOUT ANY COMPLICATIONS. DISCHARGE MEDICATIONS INCLUDED ANTIBIOTIC AND PHENAZOPYRIDINE. ON (B)(6) 2022, THE STENT WAS REMOVED SUCCESSFULLY AS PER THE INITIAL PLAN. PAIN CONTROL WAS REQUIRED AND MONITORED ANESTHESIA CARE (MAC). THE STENT WAS DIFFICULT TO REMOVE DUE TO ENCRUSTATION OF STENT BUT WAS SUCCESSFULLY REMOVED WITH THE USE OF CYSTO/GRASPERS. THE STENT WAS STILL ABLE TO DRAIN AT THE TIME OF THE PROCEDURE. ACCORDING TO THE COMPLAINANT, IT WAS FOUND THAT THE TRIA URETERAL STENT WAS ENCRUSTED. A NEW STENT WAS IMPLANTED TO THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED ON DECEMBER 05, 2022, THE ONSET DATE OF THE EVENT DIFFI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15807241 ↗
• InjuryOct 27, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED, TO BOSTON SCIENTIFIC CORPORATION. THAT A TRIA FIRM URETERAL STENT WAS USED, DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2022. DURING THE WITHDRAWAL/CLOSURE OF THE PROCEDURE, THE COIL OF THE STENT DETACHED. THE DETACHED COIL WAS REMOVED VIA GRASPING FORCEPS UNDER RIGID URETEROSCOPY. THE PROCEDURE WAS COMPLETED WITH ANOTHER TRIA FIRM URETERAL STENT. THERE WAS NO PATIENT INJURY OR COMPLICATION AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15681830 ↗
• InjuryMar 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS TO REPORTED BOSTON SCIENTIFIC CORPORATION THAT A PREVIOUSLY IMPLANTED TRIA FIRM URETERAL STENT WAS REMOVED FROM THE LEFT URETER, PERFORMED ON (B)(6) 2022 AS PART OF THE (B)(6) CLINICAL STUDY. THE TRIA URETERAL STENT WAS IMPLANTED ON (B)(6) 2021 WITH NO PROBLEMS REPORTED DURING PLACEMENT. ON (B)(6) 2022, IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE ER WITH INFECTION. ON (B)(6) 2022, THE TRIA URETERAL STENTS WAS SUCCESSFULLY REMOVED FROM THE PATIENT IN THE OPERATING ROOM. NO ISSUES WERE REPORTED WITH THE DEVICE DURING REMOVAL. A TRIA FIRM URETERAL STENT WAS SUCCESSFULLY PLACED RETROGRADE ON THE LEFT SIDE UNDER FLUOROSCOPY. ON (B)(6) 2022 THE EVENT WAS CONSIDERED RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 13830560 ↗
• MalfunctionJul 2, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRIA URETERAL STENT WAS USED DURING A PROCEDURE IN THE URETER, PERFORMED ON AN UNKNOWN DATE. DURING PREPARATION, IT WAS NOTICED THAT THE STENT SHAFT WAS BROKEN. ANOTHER TRIA URETERAL STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12107426 ↗
• MalfunctionAug 2, 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 2 MONTHS AND WAS EXPLANTED ON (B)(6) 2019, WHEN THE PLANNED STENT REMOVAL PROCEDURE WAS PERFORMED, THE STENT WAS FOUND TO HAVE BLACK DISCOLORATION. IT WAS NOTICED THAT THE STENT WAS CALCIFIED AROUND THE BLADDER SIDE AND WAS OCCLUDED. REPORTEDLY, THE PHYSICIAN HAD TO CUT THE BLADDER SIDE OF THE STENT WITH A COOPER AND A GUIDEWIRE WAS INSERTED THROUGH THE STENT TO REMOVE THE STENT FROM THE PATIENT. ANOTHER TRIA URETERAL STENT WAS IMPLANTED AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WAS NO SERIOUS INJURY, NOR WERE THERE ANY ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8857203 ↗