Tria™ Firm M0061902720Recalls & reported problems
Boston Scientific Corporation · Ureteral Stent w/o Side Holes 6Fx24CM · Class 2 · Implant
All models of Tria Firm (14)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729938132), received between May 6, 2021 and May 6, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 6, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRIA URETERAL STENT WAS USED DURING A URETERAL STENT REPLACEMENT PROCEDURE, PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, WHEN THE PHYSICIAN PLACED THE STENT, IT WAS NOTICED THAT THE STENT WAS SEPARATED FROM THE BLADDER PIGTAIL SECTION AND REMAINED INSIDE THE BODY OF THE PATIENT. THE BLADDER PIGTAIL SECTION WAS REMOVED FROM THE PATIENT, BUT THE REMAINING SECTION OF THE STENT REMAINED INSIDE THE PATIENT. ANOTHER TRIA URETERAL STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. THE REMAINING SECTION OF THE TRIA URETERAL STENT REMAINS INSIDE THE PATIENT AND THE PATIENT HAS A PLAN FOR FOLLOW-UP TO REMOVE THE REMAINING SECTION WITHIN THE NEXT FEW MONTHS. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. THE REMAINING PART OF BROKEN STENT WAS REMOVED FROM THE PATIENT BODY SUCCESSFULLY AT THE WEEK OF (B)(6) 2021.
Patient problems: Foreign Body In Patient
MAUDE report 11783712 ↗
Other Stent, ureteral devices
- Bard® InLay Optima® Ureteral Stent 788426C. R. Bard, Inc. · STENT, URETERAL1 recall100 reports
- Bard® InLay Optima® Ureteral Stent 788626C. R. Bard, Inc. · STENT, URETERAL122 reports
- Bard® InLay® Ureteral Stent with HydroGlide™ Guidewire 777626C. R. Bard, Inc. · STENT, URETERAL118 reports
- Bard® InLay® Ureteral Stent with HydroGlide™ Guidewire 777426C. R. Bard, Inc. · STENT, URETERAL108 reports
- Bard® InLay® Ureteral Stent 778626C. R. Bard, Inc. · STENT, URETERAL100 reports
- Percuflex™ Plus M0061752530Boston Scientific Corporation · STENT, URETERAL1 death99 reports
- Contour VL™ M0061801560Boston Scientific Corporation · STENT, URETERAL1 recall45 reports
- Polaris™ Ultra M0061921330Boston Scientific Corporation · STENT, URETERAL71 reports
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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