Tria™ Soft M0061903230Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 08714729959908), received between Mar 20, 2020 and Sep 29, 2026 — classified as 6 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Break” (11 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Break

  It was reported that a Tria Ureteral stent was used during a Retrograde Intrarenal Surgery (RIRS) procedure. During the procedure and inside the patient, it was noticed that the stent was broken. The procedure was completed with another of the same device and here were no patient complications reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927925 ↗
• MalfunctionAug 14, 2026Difficult to Advance; Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50250060 ↗
• MalfunctionApr 29, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT A TRIA URETERAL STENT WAS USED IN A RETROGRADE INTRARENAL SURGERY PROCEDURE. DURING THE PROCEDURE AND INSIDE THE PATIENT, IT WAS NOTICED THAT THE END OF 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 25032239 ↗
• MalfunctionFeb 5, 2026Break; Nonstandard Device

  IT WAS REPORTED THAT PRIOR TO A RETROGRADE INTRARENAL SURGERY PROCEDURE, A TRIA URETERAL STENT WAS FOUND BROKEN AFTER REMOVAL FROM THE PACKAGING. THE PROCEDURE WAS COMPLETED USING ANOTHER TRIA URETERAL STENT OF THE SAME MODEL. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24265588 ↗
• MalfunctionDec 1, 2025Break; Nonstandard Device; Detachment of Device or Device Component; Break; Nonstandard Device; Detachment of Device or Device Component

  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 23688055 ↗
• MalfunctionNov 26, 2025Break; Break

  IT WAS REPORTED THAT A TRIA URETERAL STENT WAS TO BE USED IN A PROCEDURE. DURING PREPARATION, IT WAS NOTICED THAT A PORTION OF 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 23658994 ↗
• MalfunctionAug 12, 2025Material 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 PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE, THE TRIA URETERAL STENT WAS PLACED AND THE SUTURES WERE REMOVED FROM STENT PER USUAL. AFTER STENT INSERTION, FLUOROSCOPY WAS USED AND IT WAS NOTED THAT THE COILING WAS NOT COILING PROPERLY. THE STENT WAS REMOVED, AND A SMALL TEAR WAS NOTED. STENT DISCARDED PER SURGEON, NEW STENT PLACED WITH NO ISSUE. THE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22782607 ↗
• InjuryAug 6, 2025Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, ISSUES WITH THE LACK OF CURL MEMORY ON THE DISTAL END OF THE TRIA SOFT STENTS. IT DOESN'T EASILY CURL IN THE BLADDER AND IN THIS CASE THE COIL BROKE OFF. 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 22727187 ↗
• MalfunctionJun 30, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE STENT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22367473 ↗
• MalfunctionMay 29, 2025Break; Break

  IT WAS REPORTED THAT A TRIA URETERAL STENT WAS TO BE USED IN A PROCEDURE. DURING PREPARATION, IT WAS NOTICED THAT THE STENT WAS BROKEN INTO TWO PIECES. 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 22108367 ↗
• MalfunctionApr 22, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A TRIA URETERAL STENT WAS USED IN A URETEROSCOPY PROCEDURE. DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO PLACE THE STENT AND REMOVED THE GUIDEWIRE, THE STENT DID NOT FULLY COIL IN THE KIDNEY. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21884374 ↗
• MalfunctionApr 11, 2025Break; Break

  IT WAS REPORTED THAT A TRIA URETERAL STENT WAS TO BE USED A URETEROSCOPY STENT EXCHANGE PROCEDURE. DURING PREPARATION, THE STENT BROKE INTO TWO PIECES ALONG THE SHAFT. 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 21831175 ↗
• MalfunctionMar 25, 2025Calcified; Calcified

  IT WAS REPORTED THAT A TRIA URETERAL STENT WAS IMPLANTED DURING A URETEROSCOPY PROCEDURE. POST PROCEDURE, THE PATIENT RETURNED FOR A PLANNED STENT REMOVAL PROCEDURE AND TO HAVE STONES TREATED. DURING THE PROCEDURE, IT WAS FOUND THAT THE STENT WAS ENCRUSTED AND COULD NOT PASS THE GUIDEWIRE. THE ENCRUSTED STENT WAS REMOVED WITH A GRASPER AND ANOTHER TRIA STENT WAS IMPLANTED TO THE PATIENT, WHICH HAVE COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21691825 ↗
• MalfunctionJan 27, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING PROCEDURE, THE STENT WAS FOUND SEPARATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21248877 ↗
• MalfunctionSep 3, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PREPARATION, PRIOR TO A RETROGRADE INTRARENAL SURGERY PROCEDURE USING A TRIA SOFT URETERAL STENT, IT WAS NOTICED THAT THE STENT WAS BROKEN INTO TWO PIECES ALONG THE SHAFT. ANOTHER OF THE SAME STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. THE CONDITION OF THE PATIENT AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20130844 ↗
• MalfunctionAug 20, 2024Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT, DURING PREPARATION, PRIOR TO STENT EXCHANGE, IT WAS NOTICED THAT THE PACKAGING WAS DAMAGED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20006330 ↗
• MalfunctionJun 3, 2024Break; Break

  IT WAS REPORTED THAT A TRIA SOFT URETERAL STENT WAS SEPARATED DURING INSERTION. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19454729 ↗
• MalfunctionApr 16, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRIA SOFT URETERAL STENT WAS USED TO TREAT KIDNEY STONES DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING PREPARATION, WHEN THE DEVICE WAS UNPACKED, THE STENT WAS FOUND BROKEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER TRIA SOFT URETERAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. 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 19122008 ↗
• MalfunctionMar 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRIA SOFT URETERAL STENT WAS OPENED TO BE USED TO TREAT STONE DISEASE DURING A URETEROSCOPY LASER LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2024. PRIOR TO PROCEDURE, IT WAS NOTED THAT THE STENT WAS FOUND CRACKED OR BROKEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER TRIA SOFT URETERAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. 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 18911623 ↗
• MalfunctionMar 11, 2024Unsealed Device Packaging; Unsealed Device Packaging

  NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR REPORT # 2124215-2024-12870 AND MFR. REPORT # 2124215-2024-12880). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRIA SOFT URETERAL STENT WAS OPENED TO BE USED TO TREAT STONES DURING A URETEROSCOPY PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2024. PRIOR TO PROCEDURE, WHEN THE DEVICE WAS UNPACKED, IT WAS NOTED THAT THERE WAS SOME PROBLEM WITH THE PACKAGING. THE STENT WAS FOUND COMPROMISED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN ALTERNATIVE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. 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 18876865 ↗
• 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# 3005099803-2023-05990, MFR. REPORT# 3005099803-2023-06002, 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 18106002 ↗
• MalfunctionSep 15, 2023Difficult to Remove; Material Integrity Problem; Difficult to Remove; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRIA SOFT URETERAL STENT WAS USED DURING A URETEROSCOPY PROCEDURE IN THE KIDNEY/URETER PERFORMED ON (B)(6), 2023. DURING THE PROCEDURE, THE PHYSICIAN SPENT MORE THAN THIRTY MINUTES ATTEMPTING TO RETRIEVE A STENT THAT HAD BEEN PUSHED UP INTO THE KIDNEY DUE TO THE MARKER ON THE PUSHER BEING INVISIBLE. THE STENT BECAME KNOTTED AND WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. 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 17761095 ↗
• MalfunctionMay 25, 2022Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRIA URETERAL STENT WAS USED DURING A PROCEDURE IN THE URETER, PERFORMED ON (B)(6) 2022. ON (B)(6) 2022, A STENT REMOVAL PROCEDURE WAS PERFORMED. WHEN THE PHYSICIAN REMOVED THE STENT, IT WAS NOTICED THAT THE BLADDER PIGTAIL WAS VISUALLY DEFECTIVE OR DEFORMED. ANOTHER TRIA URETERAL STENT WAS IMPLANTED IN THE PATIENT AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14502543 ↗
• InjuryFeb 3, 2021Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRIA URETERAL STENT WAS USED DURING A CYSTOSCOPY, REMOVAL OF STENT, RETROGRADE PYELOGRAM, URETEROSCOPY, LASER LITHOTRIPSY, INSERTION OF STENT PROCEDURE IN THE KIDNEY, URETER, AND BLADDER, PERFORMED ON (B)(6) 2021. REPORTEDLY THE TRIA URETERAL STENT WAS IMPLANTED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE PATIENT RETUNED TO THE EMERGENCY ROOM ON (B)(6) 2021. AN UNPLANNED STENT REMOVAL WAS PERFORMED. IT WAS NOTICED THAT THE STENT WAS OBSTRUCTED AND THE KIDNEY STONE DEBRIS WAS UNABLE TO PASS. THE PATIENT WAS DIAGNOSED WITH HYDRONEPHROSIS DUE TO THE OBSTRUCTED STENT. THERE WAS NO TREATMENT REPORTED FOR THE HYDRONEPHROSIS. THE PHYSICIAN REMOVED THE OBSTRUCTED STENT IN ITS ENTIRELY AND A NEW URETERAL STENT SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD AND SUCCESSFUL.

  Patient problems: Obstruction/Occlusion

  MAUDE report 11276581 ↗
• InjuryApr 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR# 3005099803-2020-01713 AND MFR# 3005099803-2020-01712). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRIA URETERAL STENT WAS USED IN A STENT PLACEMENT PROCEDURE FOR STONE MANAGEMENT FOR STONES IN THE RIGHT AND LEFT KIDNEYS PERFORMED ON (B)(6), 2020 AS PART OF THE U0652 DOUBLE-J REGISTRY CLINICAL STUDY. ON (B)(6), 2020, THE TRIA URETERAL STENTS WERE SUCCESSFULLY IMPLANTED IN THE RIGHT AND LEFT URETERS, AND THE PATIENT WAS PRESCRIBED ALPHA BLOCKER, ANTICHOLINERGIC, NSAIDS, AND PHENAZOPYRIDINE AT DISCHARGED. NO ISSUES WERE NOTED WITH THE DEVICES. ACCORDING TO THE COMPLAINANT, AFTER THE PROCEDURE ON (B)(6), 2020, THE PATIENT HAD EXPERIENCED URGE INCONTINENCE AND PAIN. ON (B)(6), 2020, THE STENTS WERE REMOVED AT HOME, DUE TO URGE INCONTINENCE AND PAIN, WITHOUT DIFFICULTY UTILIZING THE STENT RETRIEVAL LINE. THE STENTS WERE REMOVED, NOT PER THE INITIAL PLAN, 3 DAYS EARLIER THAN THE INTENDED PLAN. THE PATIENT WAS GIVEN AN ORAL PAIN CONTROL. ON (B)(6), 2020 THE URGE INCONTINENCE WAS CONSIDERED RESOLVED. ON (B)(6), 2020 THE PAIN WAS CONSIDERED RESOLVED. ADDITIONAL INFORMATION RECEIVED ON MARCH 16, 2023,

  Patient problems: Incontinence; Pain; Urinary Incontinence

  MAUDE report 9970207 ↗