Tria™ Firm M0061902130Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729937791), received between Jun 3, 2021 and Sep 16, 2025 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2025Deformation Due to Compressive Stress; Difficult to Advance; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE GUIDEWIRE "CROSSED THROUGH" UPON PLACING THIS STENT. HOWEVER, THE STENT DID NOT ADVANCE UP INTO THE URETER, AND IT WAS DETERMINED THAT IT COULD NOT BE PLACED. ANOTHER OF THE SAME 6FR PRODUCT WAS USED TO COMPLETE THE PROCEDURE AND PLACEMENT WAS SUCCESSFUL. THERE WERE NO PATIENT INJURIES REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23065927 ↗
• MalfunctionFeb 10, 2025Difficult to Advance; Material Integrity Problem; Difficult to Advance; Material Integrity Problem

  IT WAS REPORTED THAT A TRIA URETERAL STENT WAS USED DURING A STONE RETRIEVAL AND STENTING PROCEDURE. DURING THE PROCEDURE, THE STENT WAS DIFFICULT TO ADVANCE OVER THE WIRE FROM THE BLADDER INTO THE URETERAL ORIFICE. WITH MULTIPLE ATTEMPTS OF PULLING BACK AND ADVANCING THE DEVICE, THE STENT COILED UP AND DID NOT ADVANCE ANY FURTHER. 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 21351811 ↗
• MalfunctionDec 4, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PREPARATION, THE URETERAL STENT WAS FOUND FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE. ADDITIONAL INFORMATION WAS RECEIVED ON JANUARY 15, 2025, THAT THE COIL WAS DETACHED FROM THE STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20847667 ↗
• MalfunctionNov 27, 2024Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING UNPACKING, THE STENT WAS FOUND FRACTURED INTO TWO PARTS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20801171 ↗
• InjurySep 6, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE, USING A TRIA URETERAL STENT, THE STENT BECAME BUCKLED MULTIPLE TIMES OVER THE GUIDEWIRE. ADDITIONALLY, THE RADIOPAQUE MARKER OF THE PUSHER WAS SEPARATED AND WAS FLOATING AROUND THE KIDNEY. THE BROKEN METAL PIECE WAS RETRIEVED WITH GRASPING FORCEPS. ANOTHER OF THE SAME STENT WAS USED TO COMPLETE THE PROCEDURE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THIS REPORT IS ONE OF THE TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR. # 2124215-2024-55156 AND MFR. REPORT # .).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20163121 ↗
• InjurySep 4, 2024Material Separation; Deformation Due to Compressive Stress; Difficult to Advance; Material Separation; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT, DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE, USING A TRIA URETERAL STENT, THE STENT BECAME BUCKLED MULTIPLE TIMES OVER THE GUIDEWIRE. ADDITIONALLY, THE RADIOPAQUE MARKER OF THE PUSHER WAS SEPARATED AND WAS FLOATING AROUND THE KIDNEY AND HAD TO BE RETRIEVED WITH GRASPING FORCEPS. ANOTHER OF THE SAME STENT WAS USED TO COMPLETE THE PROCEDURE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20139328 ↗
• MalfunctionFeb 21, 2024Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRIA FIRM URETERAL STENT WAS USED TO TREAT KIDNEY STONES DURING A FLEXIBLE URETERAL LITHOTRIPSY PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, IT WAS NOTED THAT THE STENT WAS DIFFICULT TO IMPLANT. THE PROCEDURE WAS COMPLETED WITH ANOTHER TRIA FIRM URETERAL STENT AND 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 STABLE. ACCOUNT MENTIONS ON (B)(6) 2024 STENT WAS PLACED IN THE PATIENT THEREFORE THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT. INVESTIGATION RESULTS REVEALED THAT THE STENT WAS BUCKLED, PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18754460 ↗
• MalfunctionJun 26, 2023Deformation Due to Compressive Stress; Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Deformation Due to Compressive Stress; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A TRIA URETERAL STENT WAS USED DURING A URETEROSCOPY PROCEDURE IN THE RIGHT URETER PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, WHEN ATTEMPTING TO INSERT THE STENT USING THE POSITIONER, THE TAIL BECAME BUCKLED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER TRIA 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 GOOD. 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 17200285 ↗
• MalfunctionJun 3, 2021Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRIA FIRM URETERAL STENT WAS USED DURING A URETERAL OBSTRUCTION - TUMOR PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTED THAT THE STENT BUCKLED INSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE ORIGINAL 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 FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11931269 ↗