Tria™ Soft M0061903310Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729959922), received between May 25, 2022 and Apr 27, 2026 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2026Nonstandard Device; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A PROCEDURE, A TRIA URETERAL STENT WAS USED, AND NOTICED THAT THE CATHETER CUTS ITSELF OFF. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25009941 ↗
• InjuryMar 23, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A TRIA SOFT URETERAL STENT WAS USED DURING A LASER LITHOTRIPSY PROCEDURE IN THE KIDNEY, PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE AND INSIDE THE PATIENT, IT WAS NOTED THAT THE STENT WAS BROKEN INTO TWO PIECES ALONG THE SHAFT. THE BROKEN PIECE OF STENT WAS REMOVED WITH GRASPERS AND ANOTHER TRIA SOFT URETERAL STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16601002 ↗
• MalfunctionAug 5, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRIA SOFT URETERAL STENT WAS OPENED TO BE USED DURING A STENT EXCHANGE PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, WHEN TRYING TO REMOVE THE TRIA SOFT URETERAL STENT FROM THE PACKAGING, IT WAS FOUND THAT THE STENT SHAFT WAS BROKEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER TRIA SOFT URETERAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. 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 15179311 ↗
• InjuryJul 22, 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 INDICATED FOR STONE MANAGEMENT; LASER LITHOTRIPSY IN 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. THE PROCEDURE WAS PERFORMED WITHOUT ANY COMPLICATIONS. DISCHARGE MEDICATIONS INCLUDED ACETAMINOPHEN (TYLENOL), ALPHA BLOCKER, ANTIBIOTIC, AND NSAIDS. ON (B)(6) 2022, THE PATIENT EXPERIENCED MILD DYSURIA AND MILD GROSS HEMATURIA POSSIBLY RELATED TO THE DEVICE AND STENT REMOVAL PROCEDURE. BACTRIM MEDICATION WAS GIVEN TO THE PATIENT. THE ADVERSE EVENT WAS REPORTED TO BE RESOLVED ON (B)(6) 2022. THERE WERE NO NEW DEVICE IMPLANTED. STENT REMOVAL PROCEDURE INFORMATION IS UNKNOWN.

  Patient problems: Dysuria; Hematuria; Pain

  MAUDE report 15089793 ↗
• InjuryJun 6, 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 FOR STONE MANAGEMENT FOR STONES IN THE RIGHT URETER PERFORMED ON (B)(6) 2022 AS PART OF THE U0652 DOUBLE-J REGISTRY CLINICAL STUDY. THE SUBJECT WAS PRE-STENTED ON (B)(6) 2022 WITH ONE STENT TO THE RIGHT URETER, WHICH WAS REMOVED ON (B)(6) 2022 IN OPERATING ROOM. ON (B)(6) 2022, THE TRIA URETERAL STENT WAS SUCCESSFULLY PLACED FOR STONE MANAGEMENT LASER LITHOTRIPSY (WITH OR WITHOUT EXTRACTION) IN THE RIGHT URETER. NO ISSUES WERE REPORTED WITH THE DEVICE DURING PLACEMENT. DISCHARGE MEDICATIONS INCLUDED ALPHA BLOCKER, ANTICHOLINERGIC, NSAIDS, AND PHENAZOPYRIDINE. ACCORDING TO THE COMPLAINANT, FOLLOWING THE PROCEDURE, ON (B)(6) 2022, THE PATIENT HAD EXPERIENCED MODERATE RIGHT FLANK PAIN. THE PATIENT WAS GIVEN TYLENOL ES, ADVIL DUAL AND OXYBUTYNIN TO TREAT THE PAIN. A PLANNED STENT REMOVAL PROCEDURE WAS PERFORMED AND THE STENT WAS SUCCESSFULLY REMOVED WITHOUT ANY DIFFICULTY. ORAL PAIN CONTROL WAS GIVEN TO THE PATIENT. THERE WERE NO NEW DEVICE IMPLANTED. NO ISSUES WERE NOTED WITH THE DEVICES DURING REMOVAL. ON (B)(6) 2022, THE EVENT WAS CONSIDERED RESOLVED.

  Patient problems: Pain

  MAUDE report 14607463 ↗
• InjuryMay 25, 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 FOR STONE MANAGEMENT FOR STONES IN THE RIGHT URETER PERFORMED ON (B)(6) 2022 AS PART OF THE (B)(6) CLINICAL STUDY. ON (B)(6) 2022, THE TRIA URETERAL STENT WAS SUCCESSFULLY PLACED FOR STONE MANAGEMENT FOR STONES IN THE RIGHT URETER UNDER FLUOROSCOPY. NO ISSUES WERE REPORTED WITH THE DEVICE DURING PLACEMENT. ACCORDING TO THE COMPLAINANT, FOLLOWING THE PROCEDURE, THE PATIENT HAD EXPERIENCED INCREASED URETHRAL PAIN. THE PATIENT WAS GIVEN TORADOL TO TREAT THE PAIN. ON (B)(6) 2022 THE EVENT WAS CONSIDERED RESOLVED. ON (B)(6) 2022, DURING THE PLANNED STENT REMOVAL PROCEDURE, THE STENT WAS SUCCESSFULLY REMOVED WITHOUT ANY DIFFICULTY. LOCAL ANESTHESIA WAS REQUIRED FOR PAIN. THERE WERE NO NEW DEVICE IMPLANTED. NO ISSUES WERE NOTED WITH THE DEVICES DURING REMOVAL.

  Patient problems: Pain

  MAUDE report 14502397 ↗