Tria SoftRecalls & reported problems across all models

We found 11 models of Tria Soft by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 113 adverse event reports in the FDA's MAUDE database, received between Mar 20, 2020 and Sep 29, 2026 — classified as 39 injuries, 74 malfunctions.

The most frequently reported specific device problem is “Break” (37 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Tria Soft problems

Tria Soft models

11 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Tria™ Soft M0061903220

  Stent, ureteral
  49 reports
• Tria™ Soft M0061903230

  Stent, ureteral
  28 reports
• Tria™ Soft M0061903320

  Stent, ureteral
  8 reports
• Tria™ Soft M0061903240

  Stent, ureteral
  7 reports
• Tria™ Soft M0061903210

  Stent, ureteral
  6 reports
• Tria™ Soft M0061903310

  Stent, ureteral
  6 reports
• Tria™ Soft M0061903330

  Stent, ureteral
  3 reports
• Tria™ Soft M0061903200

  Stent, ureteral
  2 reports
• Tria™ Soft M0061903250

  Stent, ureteral
  2 reports
• Tria™ Soft M0061903430

  Stent, ureteral
  1 report
• Tria™ Soft M0061903440

  Stent, ureteral
  1 report

Recent Tria Soft adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionApr 21, 2026Break; Nonstandard Device

  IT WAS REPORTED THAT DURING A PROCEDURE, A TRIA SOFT URETERAL STENT WAS INTENDED TO BE USED. DURING THE PREPARATION, WHEN THE DEVICE WAS OPENED, IT WAS FOUND THAT THE STENT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24947743 ↗
• 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 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 ↗
• 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 ↗
• MalfunctionJan 21, 2026Break; Nonstandard Device

  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 24127378 ↗
• MalfunctionJan 20, 2026Break; Nonstandard Device

  IT WAS REPORTED THAT A TRIA URETERAL STENT WAS TO BE USED IN A PROCEDURE. DURING UNPACKING, IT WAS FOUND THAT 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 24126054 ↗
• 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 ↗
• 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 ↗

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