Tria™ Soft M0061903200Recalls & reported problems
Boston Scientific Corporation · Ureteral Stent · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729953951), received between Nov 9, 2023 and Apr 21, 2026 — classified as 1 injury, 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- Break1
- Calcified1
- Migration1
- Nonstandard Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 ↗InjuryNov 9, 2023Calcified; Migration; Calcified; Migration
NOTE: THIS REPORT IS ONE OF FIVE COMPLAINTS THAT PERTAIN TO THE SAME EVENT (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 18106046 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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