Tria™ Soft M0061903220Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 08714729959892), received between Mar 26, 2020 and Sep 29, 2026 — classified as 16 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928412 ↗
• MalfunctionApr 14, 2026Break; Nonstandard Device

  IT WAS REPORTED THAT A TRIA URETERAL STENT WAS USED IN A PROCEDURE. DURING THE PROCEDURE, IT WAS NOTICED THAT THE STENT BROKE. THERE WAS NO INFORMATION ON WHAT HAVE COMPLETED THE PROCEDURE WAS THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24868060 ↗
• MalfunctionMar 23, 2026Break

  IT WAS REPORTED THAT A TRIA URETERAL STENT WAS USED IN CYSTOSCOPY WITH STENT PROCEDURE. DURING THE PROCEDURE, IT WAS NOTICED THAT THE STENT BROKE APART. 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 24671126 ↗
• MalfunctionFeb 4, 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 NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24255754 ↗
• MalfunctionJan 22, 2026Break; Nonstandard Device

  IT WAS REPORTED THAT A TRIA URETERAL STENT WAS TO BE USED IN A PROCEDURE. DURING PREPARATION, IT WAS FOUND THAT THE STAND OF THE STENT WAS BROKEN. THERE WAS NO INFORMATION ON WHAT HAVE COMPLETED THE PROCEDURE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24157643 ↗
• MalfunctionDec 19, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT A TRIA URETERAL STENT WAS TO BE USED IN A RETROGRADE INTRARENAL SURGERY. 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 23854567 ↗
• MalfunctionOct 24, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT A TRIA URETERAL STENT WAS TO BE USED IN A RETROGRADE INTRARENAL SURGERY. 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. ADDITIONAL INFORMATION RECEIVED ON OCTOBER 28, 2025, STATING THAT THE COIL PART OF THE STENT WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23386503 ↗
• MalfunctionMay 20, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT A TRIA URETERAL STENT WAS ATTEMPTED TO BE IMPLANTED IN THE KIDNEY DURING A URS (URETEROSCOPY) PROCEDURE. DURING THE PROCEDURE, IT WAS NOTICED THAT THE STENT BUCKLED. 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 22053318 ↗
• MalfunctionApr 24, 2025Break; Break

  IT WAS REPORTED THAT A TRIA URETERAL STENT WAS USED IN A PROCEDURE AND THE STENT WAS CUT OFF. THERE WAS NO INFORMATION ON WHAT COMPLETED THE PROCEDURE AND THERE WERE NO KNOWN PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21904725 ↗
• InjuryApr 4, 2025Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRIA SOFT URETERAL STENT WITH SIDE HOLES DEVICE WAS USED TO TREAT A RIGHT NEPHROLITHIASIS WITH INFUNDIBULAR STENOSES DURING A RIGHT PERCUTANEOUS NEPHROSTOLITHOTOMY (PCNL) OF STONE GREATER THAN 2 CM PROCEDURE PERFORMED SOMETIME IN (B)(6) 2022. FOUR DAYS POST-PROCEDURE, THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) WITH DRAINAGE FROM FLANK INCISIONS. POST-OPERATIVE COMPUTED TOMOGRAPHY (CT) REVEALED DISTAL MIGRATION OF THE URETERAL STENT, RESULTING IN INADEQUATE KIDNEY DRAINAGE. THE STENT WAS SUBSEQUENTLY REMOVED VIA CYSTOSCOPY. PER PHYSICIAN'S ASSESSMENT, THE EVENT WAS SERIOUS, WAS POSSIBLY RELATED TO THE DEVICE, AND PROBABLY RELATED TO THE PROCEDURE.

  Patient problems: Fluid Discharge; Renal Failure

  MAUDE report 21777873 ↗
• MalfunctionDec 11, 2024Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE URETEROSCOPY PREPARATION, WHILE THE DEVICE WAS STILL OUTSIDE THE PATIENT, IT WAS NOTICED THAT THE COIL OF THE TRIA SOFT URETERAL STENT WAS DETACHED WHEN THE SUTURE WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20907077 ↗
• InjuryAug 28, 2024Migration; Migration

  IT WAS REPORTED THAT THE PREVIOUSLY IMPLANTED TRIA URETERAL STENT HAD MIGRATED OUT OF THE URETHRA AND THE PATIENT HAD EXPERIENCED DISCOMFORT, FLANK PAIN, URINARY INCONTINENCE, AND VOMITING. IT WAS REPORTED THAT POST-PROCEDURE, THE MIGRATED STENT HAD TO BE REMOVED AND REPOSITIONED BY THE PHYSICIAN. THE STENT WAS SUPPOSED TO BE PLACED IN THE PATIENT FOR APPROXIMATELY 5 TO SEVEN DAYS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Discomfort; Pain; Urinary Incontinence; Vomiting

  MAUDE report 20085988 ↗
• InjuryAug 27, 2024Migration; Migration

  IT WAS REPORTED THAT THE PREVIOUSLY IMPLANTED TRIA URETERAL STENT HAD MIGRATED OUT OF THE URETHRA AND THE PATIENT HAD EXPERIENCED DISCOMFORT, FLANK PAIN, URINARY INCONTINENCE, AND VOMITING. IT WAS REPORTED THAT POST-PROCEDURE, THE MIGRATED STENT HAD TO BE REMOVED AND REPOSITIONED BY THE PHYSICIAN. THE STENT WAS SUPPOSED TO BE PLACED IN THE PATIENT FOR APPROXIMATELY 5 TO SEVEN DAYS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Discomfort; Pain; Urinary Incontinence; Vomiting

  MAUDE report 20080100 ↗
• MalfunctionAug 27, 2024Migration; Migration

  IT WAS REPORTED THAT THE PREVIOUSLY IMPLANTED TRIA URETERAL STENT HAD MIGRATED INTO THE MID-URETHRA AND THE PATIENT HAD EXPERIENCED DISCOMFORT, FLANK PAIN, URINARY INCONTINENCE, AND VOMITING. THE PATIENT REMOVED THE STENT BY HIMSELF. NO NEW STENT WAS REPORTED TO HAVE REPLACED THE MIGRATED STENT. THE STENT WAS SUPPOSED TO BE PLACED IN THE PATIENT FOR APPROXIMATELY FIVE TO SEVEN DAYS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Discomfort; Pain; Urinary Incontinence; Vomiting

  MAUDE report 20078483 ↗
• MalfunctionAug 27, 2024Migration; Migration

  IT WAS REPORTED THAT THE PREVIOUSLY IMPLANTED TRIA URETERAL STENT HAD MIGRATED INTO THE MID-URETHRA AND THE PATIENT HAD EXPERIENCED DISCOMFORT, FLANK PAIN, URINARY INCONTINENCE, AND VOMITING. THE PATIENT REMOVED THE STENT BY THEMSELF. NO NEW STENT WAS REPORTED TO HAVE REPLACED THE MIGRATED STENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Discomfort; Pain; Urinary Incontinence; Vomiting

  MAUDE report 20077735 ↗
• MalfunctionAug 26, 2024Migration; Migration

  IT WAS REPORTED THAT THE PREVIOUSLY IMPLANTED TRIA URETERAL STENT HAD MIGRATED INTO THE MID-URETHRA AND THE PATIENT HAD EXPERIENCED DISCOMFORT, FLANK PAIN, URINARY INCONTINENCE, AND VOMITING. THE PATIENT REMOVED THE STENT BY THEMSELVES. NO NEW STENT WAS REPORTED TO HAVE REPLACED THE MIGRATED STENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Discomfort; Pain; Urinary Incontinence; Vomiting

  MAUDE report 20071881 ↗
• MalfunctionAug 26, 2024Migration; Migration

  IT WAS REPORTED THAT THE PREVIOUSLY IMPLANTED TRIA URETERAL STENT HAD MIGRATED INTO THE MID-URETHRA AND THE PATIENT HAD EXPERIENCED DISCOMFORT, FLANK PAIN, URINARY INCONTINENCE, AND VOMITING. THE PATIENT REMOVED THE STENT BY THEMSELF. NO NEW STENT WAS REPORTED TO HAVE REPLACED THE MIGRATED STENT. THE STENT WAS INTENDED TO BE PLACED IN THE PATIENT FOR APPROXIMATELY FIVE TO SEVEN DAYS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Discomfort; Pain; Urinary Incontinence; Vomiting

  MAUDE report 20071877 ↗
• MalfunctionAug 26, 2024Migration; Migration

  IT WAS REPORTED THAT THE PREVIOUSLY IMPLANTED TRIA URETERAL STENT HAD MIGRATED INTO THE MID-URETHRA AND THE PATIENT HAD EXPERIENCED DISCOMFORT, FLANK PAIN, URINARY INCONTINENCE, AND VOMITING. THE PATIENT REMOVED THE STENT BY THEMSELF. NO NEW STENT WAS REPORTED TO HAVE REPLACED THE MIGRATED STENT. THE STENT WAS INTENDED TO BE PLACED IN THE PATIENT FOR APPROXIMATELY 5 TO SEVEN DAYS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Discomfort; Pain; Urinary Incontinence; Vomiting

  MAUDE report 20071680 ↗
• MalfunctionAug 26, 2024Migration; Migration

  IT WAS REPORTED THAT THE PREVIOUSLY IMPLANTED TRIA URETERAL STENT HAD MIGRATED INTO THE MID-URETHRA AND THE PATIENT HAD EXPERIENCED DISCOMFORT, FLANK PAIN, URINARY INCONTINENCE, AND VOMITING. THE PATIENT REMOVED THE STENT BY THEMSELF. NO NEW STENT WAS REPORTED TO HAVE REPLACED THE MIGRATED STENT. THE STENT WAS INTENDED TO BE PLACED IN THE PATIENT FOR APPROXIMATELY 5 TO SEVEN DAYS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Discomfort; Pain; Urinary Incontinence; Vomiting

  MAUDE report 20071676 ↗
• InjuryJul 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT HAD A SUCCESSFUL TRIA URETERAL STENT PLACEMENT. ON (B)(6) 2024, THE PATIENT RETURNED FOR URETEROSCOPIC STONE EXTRACTION WITH LASER LITHOTRIPSY; REMOVAL AND REINSERTION OF URETERAL STENT. A FOLLOW UP WAS SUGGESTED CONCERNING THE FOREIGN BODY FOUND THAT PROBABLY A BROKEN PIECE OF THE STENT AND PRESENCE OF RESIDUAL STONES, AND WAS RECOMMENDED TO UNDERGO SECOND URETEROSCOPY WITH LASER LITHOTRIPSY AND REMOVAL OF FOREIGN BODY. ON (B)(6) 2024, A CYSTOSCOPY PROCEDURE WAS PERFORMED FOR STENT REMOVAL AND FOREIGN BODY REMOVAL OF THE BROKEN STENT TIP FROM THE IMPLANTED STENT ON (B)(6) 2024. NO STENT REINSERTION REQUIRED. IT WAS REPORTED THAT THERE WERE NO PATIENT COMPLICATIONS REPORTED AFTER EACH PROCEDURE. THE CONDITION OF THE PATIENT AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19842630 ↗
• MalfunctionJul 10, 2024Break; Break

  IT WAS REPORTED THAT, DURING A CYSTOSCOPY PROCEDURE USING A TRIA SOFT URETERAL STENT, IT WAS NOTICED DURING PREPARATION THAT THE STENT BROKE IN HALF WHEN THE STRING WAS PULLED. ANOTHER OF THE SAME STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19711265 ↗
• MalfunctionMar 18, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRIA SOFT URETERAL STENT WAS OPENED TO BE USED DURING A STENT EXCHANGE PROCEDURE PERFORMED ON (B)(6) 2024. DURING PREPARATION, WHEN THE STENT WAS REMOVED FROM THE PACKAGE SLEEVE, IT WAS NOTED THE STENT WAS BROKEN IN TWO PIECES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER TRIA SOFT URETERAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18927045 ↗
• MalfunctionMar 12, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TRIA URETERAL STENT WAS USED DURING A URETEROSCOPY IN THE URETER FOR KIDNEY STONE MANAGEMENT, PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, IT WAS FOUND THAT THERE WAS A HOLE IN THE TIP OF THE STENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER TRIA URETERAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED ON MARCH 19, 2024, STATING THAT THE PROBLEM OCCURRED OUTSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18887243 ↗
• 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, MFR. REPORT# 3005099803-2023-06005 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 18106031 ↗
• MalfunctionAug 21, 2023Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A TRIA SOFT URETERAL STENT WAS USED DURING A URETEROSCOPY LASER LITHOTRIPSY PROCEDURE IN THE URINARY SYSTEM PERFORMED ON (B)(6), 2023. DURING THE PROCEDURE, IT WAS NOTICED THAT THE COIL PART OF THE STENT WAS BENT. THE COIL PART WAS DETACHED DURING THE PROCESS, BUT IT HAD ALREADY BEEN BENT BEFORE IT WAS PUT INTO USE. THE BROKEN COIL OF THE STENT WAS SUCCESSFULLY RETRIEVED USING A GRASPER AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER POLARIS ULTRA URETERAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON 06SEP2023, CONFIRMING THAT THEY ACTUALLY DID NOT USE A GRASPER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17592146 ↗