Tria™ Soft M0061903320Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729959939), received between Dec 28, 2021 and Oct 2, 2025 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 2, 2025Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT A TRIA URETERAL STENT WAS USED IN A URETEROSCOPY PROCEDURE IN THE KIDNEY, URETER AND BLADDER. DURING INSERTION, IT WAS NOTICED THAT THE STENT KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE DAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. ADDITIONAL INFORMATION RECEIVED ON OCTOBER 03, 2025, CLARIFIED THAT THE EVENT OCCURRED OUTSIDE THE PATIENT AND THE COIL WAS ALSO DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23206375 ↗
• MalfunctionApr 7, 2023Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A TRIA SOFT URETERAL STENT WAS TO BE USED DURING A RETROGRADE INTRARENAL SURGERY PROCEDURE IN THE KIDNEY STONE, PERFORMED ON (B)(6) 2023. DURING PREPARATION, WHEN THE DEVICE WAS CHECKED, IT WAS NOTED THAT THE STENT WAS BROKEN ALONG THE SHAFT. ANOTHER TRIA URETERAL STENT WAS OPENED AND USED AND SUCCESSFULLY COMPLETED THE PROCEDURE. 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. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THAT THE STENT SHAFT WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16704502 ↗
• InjuryMar 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TRIA SOFT URETERAL STENT WAS IMPLANTED DURING A LASER LITHOTRIPSY PROCEDURE IN THE LEFT URETER ON (B)(6) 2020, AS PART OF THE U0652 DOUBLE-J REGISTRY CLINICAL STUDY. THE STENT WAS SUCCESSFULLY IMPLANTED, AND THE PATIENT WAS PRESCRIBED AN ALPHA BLOCKER AND ANTIBIOTIC AT DISCHARGE. ON (B)(6) 2022, IT WAS REPORTED THAT THE PATIENT DEVELOPED SEPSIS DUE TO A NEW URINARY TRACT INFECTION (UTI). IT WAS NOTED THAT THE PATIENT HAD PRESENTED TO THE EMERGENCY ROOM WITH SYMPTOMS OF BILATERAL FLANK PAIN, DYSURIA, LOWER EXTREMITY MYALGIAS AND A 102-DEGREE FEVER. URINE CULTURES RESULTED WITH ESCHERICHIA COLI (E COLI). THE PATIENT WAS GIVEN UNASYN, ZOSYN, LEVAQUIN AND AUGMENTIN. THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2022, TO (B)(6) 2022. THE PATIENT WAS DISCHARGED WITH AUGMENTIN FOR TWO ADDITIONAL DAYS TO COMPLETE A 7-DAY COURSE. THE EVENT WAS ASSESSED AS POSSIBLY RELATED TO THE PROCEDURE AND POSSIBLY RELATED TO THE DEVICE. ON DECEMBER 16, 2022, THE EVENT WAS CONSIDERED RESOLVED.

  Patient problems: Dysuria; Fever; Pain; Sepsis; Urinary Tract Infection

  MAUDE report 16571801 ↗
• InjuryAug 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS TO REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PREVIOUSLY IMPLANTED PERCUFLEX PLUS URETERAL STENT WAS REMOVED FROM THE LEFT URETER, PERFORMED ON (B)(6) 2022 AS PART OF THE U0652 DOUBLE-J REGISTRY CLINICAL STUDY. ON (B)(6) 2022, THE PERCUFLEX PLUS URETERAL STENT WAS SUCCESSFULLY PLACED FOR STONE MANAGEMENT IN THE LEFT URETER, AND THE PATIENT WAS PRESCRIBED THE DISCHARGE MEDICATIONS ALPHA BLOCKER, ANTICHOLINERGIC, AND PHENAZOPYRIDINE. NO ISSUES WERE NOTED WITH THE DEVICE. ON (B)(6) 2022, THE PATIENT HAD EXPERIENCED A LEFT AND RIGHT FLANK PAIN. THE PATIENT WAS GIVEN OXYBUTYNIN, PYRIDIUM TO TREAT THE PAIN. DURING THE PLANNED STENT REMOVAL PERFORMED ON (B)(6) 2022, THE PERCUFLEX PLUS URETERAL STENT WAS SUCCESSFULLY REMOVED FROM THE PATIENT WITHOUT ANY DIFFICULTY. THERE WERE NO NEW DEVICE IMPLANTED. ON (B)(6) 2022 THE EVENT WAS CONSIDERED RESOLVED.

  Patient problems: Dysuria; Micturition Urgency; Pain

  MAUDE report 15183975 ↗
• InjuryJul 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRIA URETERAL STENT WAS USED IN A STENT PLACEMENT STUDY PROCEDURE IN THE LEFT URETER PERFORMED ON (B)(6) 2022 AS PART OF THE U0652 DOUBLE-J REGISTRY CLINICAL STUDY. ON (B)(6) 2022, THE TRIA URETERAL STENT WAS SUCCESSFULLY PLACED IN THE LEFT URETER UNDER FLUOROSCOPY. NO ISSUES WERE REPORTED WITH THE DEVICE DURING PLACEMENT. DISCHARGE MEDICATIONS INCLUDED ANTIBIOTICS AND NARCOTIC ANALGESICS (OPIOIDS). ON (B)(6) 2022, THE PATIENT EXPERIENCED MILD URINARY TRACT INFECTION POSSIBLY RELATED TO THE STENT REMOVAL PROCEDURE. AUGMENTIN MEDICATION WAS GIVEN TO THE PATIENT. THE ADVERSE EVENT WAS REPORTED TO BE RESOLVE ON (B)(6) 2022. THE RELATIONSHIP BETWEEN THE DEVICE AND THE ADVERSE EVENT WAS REPORTEDLY TO BE POSSIBLY RELATED AND THE RELATIONSHIP BETWEEN THE PROCEDURE AND THE ADVERSE EVENT WAS REPORTEDLY TO BE POSSIBLY RELATED THERE WERE NO NEW DEVICE IMPLANTED.

  Patient problems: Urinary Tract Infection

  MAUDE report 15117382 ↗
• InjuryJun 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PREVIOUSLY IMPLANTED TRIA SOFT URETERAL STENT WAS REMOVED FROM THE LEFT URETER, PERFORMED ON (B)(6) 2022 AS PART OF THE U0652 DOUBLE-J REGISTRY CLINICAL STUDY. ON (B)(6) 2022, THE TRIA SOFT URETERAL STENT WAS SUCCESSFULLY PLACED FOR STONE MANAGEMENT IN THE LEFT URETER, AND THE PATIENT WAS PRESCRIBED THE DISCHARGE MEDICATIONS, ACETAMINOPHEN (TYLENOL), ALPHA BLOCKER, ANTIBIOTIC, AND NARCOTIC ANALGESICS (OPIOIDS). NO ISSUES WERE NOTED WITH THE DEVICE. ON (B)(6) 2022, THE PATIENT HAD EXPERIENCED AN INCREASED URETHRAL PAIN STATUS DUE TO POST STENT PLACEMENT . THE PATIENT WAS GIVEN TYLENOL AND OXYCODONE TO TREAT THE PAIN. DURING THE PLANNED STENT REMOVAL PERFORMED ON (B)(6) 2022, THE TRIA SOFT URETERAL STENT WAS SUCCESSFULLY REMOVED FROM THE PATIENT WITHOUT ANY DIFFICULTY. THERE WAS NO NEW DEVICE IMPLANTED. ON (B)(6) 2022 THE EVENT WAS CONSIDERED RESOLVED.

  Patient problems: Pain

  MAUDE report 14859370 ↗
• InjuryJun 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRIA URETERAL STENT WAS IMPLANTED DURING A STENT PLACEMENT PROCEDURE FOR STONE PLACEMENT MANAGEMENT AND LASER LITHOTRIPSY IN THE LEFT KIDNEY ON (B)(6) 2020 AS PART OF THE U0652 DOUBLE-J CLINICAL STUDY. DISCHARGE MEDICATIONS INCLUDED ANTIBIOTIC, ALPHA BLOCKER, ANTICHOLINERGIC, AND PHENAZOPYRIDINE WERE GIVEN TO THE PATIENT. ON (B)(6) 2020, THE PATIENT EXPERIENCED MILD INCOMPLETE EMPTYING. THE PATIENT HAD A CATHETER INSERTION AND WAS HOSPITALIZED FROM (B)(6) 2020 TO (B)(6) 2020. THE ADVERSE EVENT WAS CONSIDERED TO BE RESOLVED AS OF NOVEMBER 27, 2020.

  Patient problems: Urinary Retention

  MAUDE report 14789749 ↗
• InjuryDec 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRIA URETERAL STENTS WAS USED DURING A STENT PLACEMENT PROCEDURE IN THE RIGHT URETER UNDER CYSTOSCOPY, PERFORMED ON (B)(6) 2021 AS PART OF THE (B)(6) CLINICAL STUDY. THE STENT PLACEMENT PROCEDURE FOR STONE MANAGEMENT WAS PERFORMED INCLUDING LASER LITHOTRIPSY (WITH OR WITHOUT EXTRACTION). THE SUBJECT WAS PRE-STENTED ON (B)(6) 2021 TO THE LEFT URETER WHICH WAS REMOVED ON (B)(6) 2021 IN THE OPERATING ROOM. ON (B)(6) 2021, THE RIGHT SIDE STENT WAS SUCCESSFULLY IMPLANTED TO THE PATIENT. THE PATIENT WAS PRESCRIBED WITH ACETAMINOPHEN, ANTIBIOTIC, PHENAZOPYRIDINE, NARCOTIC ANALGESICS AND NSAIDS AT DISCHARGE. NO ISSUES WERE NOTED WITH THE DEVICES. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2021, THE RIGHT SIDE STENT WAS REMOVED SUCCESSFULLY AS PER INITIAL PLAN. STENT WAS NOT DIFFICULT TO REMOVE AND ORAL PAIN MEDICATION WAS NOT REQUIRED. ON (B)(6) POST PROCEDURE, SEVER PAIN WAS EXPERIENCED BY THE PATIENT AND WAS GIVEN OXYCODONE/ACETAMINOPHEN. THE EVENT WAS CONSIDERED TO BE RESOLVED AS OF ON (B)(6) 2021. IN THE PHYSICIAN'S ASSESSMENT, THE RELATIONSHIP BETWEEN THE PROCEDURE AND THE EVENT IS POSSIBLY RELATED, THERE IS NO RELATIONSHIP BETWEEN

  Patient problems: Fever; Pain

  MAUDE report 13101427 ↗