Tria FirmRecalls & reported problems across all models
Boston Scientific Corporation · 14 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 50
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls
- 0
We found 14 models of Tria Firm by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 50 adverse event reports in the FDA's MAUDE database, received between Jul 15, 2019 and Aug 11, 2026 — classified as 9 injuries, 41 malfunctions.
The most frequently reported specific device problem is “Break” (19 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
Reports received per month, all models
Most reported Tria Firm problems
Device problems
- Break19
- Adverse Event Without Identified Device or Use Problem9
- Detachment of Device or Device Component9
- Difficult to Advance7
- Calcified5
- Material Deformation5
- Deformation Due to Compressive Stress4
- Material Integrity Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions41
- No Consequences Or Impact To Patient5
- Unspecified Infection3
- Pain2
- Urinary Retention2
- Foreign Body In Patient1
- No Known Impact Or Consequence To Patient1
Tria Firm models
14 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Tria™ Firm M0061902220Stent, ureteral11 reports
- Tria™ Firm M0061902230Stent, ureteral10 reports
- Tria™ Firm M0061902130Stent, ureteral9 reports
- Tria™ Firm M0061902120Stent, ureteral4 reports
- Tria™ Firm M0061902320Stent, ureteral4 reports
- Tria™ Firm M0061902420Stent, ureteral3 reports
- Tria™ Firm M0061902210Stent, ureteral2 reports
- Tria™ Firm M0061902110Stent, ureteral1 report
- Tria™ Firm M0061902240Stent, ureteral1 report
- Tria™ Firm M0061902330Stent, ureteral1 report
- Tria™ Firm M0061902340Stent, ureteral1 report
- Tria™ Firm M0061902410Stent, ureteral1 report
- Tria™ Firm M0061902430Stent, ureteral1 report
- Tria™ Firm M0061902720Stent, ureteral1 report
Recent Tria Firm adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 11, 2026Nonstandard Device; Detachment of Device or Device Component; Material Split, Cut or Torn
It was reported that a Tria Ureteral stent was used in a Retrograde Intrarenal Surgery procedure in the left kidney. During the procedure, when the stent was inserted, it was noticed that the stent was torn and the coil was detached. 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 50211005 ↗MalfunctionApr 20, 2026Break; 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 COMPETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24933924 ↗MalfunctionApr 14, 2026Break; Nonstandard Device
IT WAS REPORTED THAT DURING A RETROGRADE INTRARENAL SURGERY PROCEDURE A TRIA URETERAL STENT WAS INTENDED TO BE USED; HOWEVER, IT WAS FOUND THAT THE STENT WAS BROKEN. 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 24879262 ↗MalfunctionApr 1, 2026Break
IT WAS REPORTED THAT A TRIA URETERAL STENT WAS INTENDED TO BE USED DURING A PROCEDURE. THE STENT WAS FOUND TO BE DETACHED WITHIN THE SHAFT NEAR THE DISTAL END WHILE STILL OUTSIDE THE PATIENT. 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 24756151 ↗MalfunctionFeb 3, 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 REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24243457 ↗MalfunctionSep 16, 2025Deformation Due to Compressive Stress; Difficult to Advance; Deformation Due to Compressive Stress; Difficult to Advance
IT WAS REPORTED THAT DURING THE PROCEDURE, THE GUIDEWIRE "CROSSED THROUGH" UPON PLACING THIS STENT. HOWEVER, THE STENT DID NOT ADVANCE UP INTO THE URETER, AND IT WAS DETERMINED THAT IT COULD NOT BE PLACED. ANOTHER OF THE SAME 6FR PRODUCT WAS USED TO COMPLETE THE PROCEDURE AND PLACEMENT WAS SUCCESSFUL. THERE WERE NO PATIENT INJURIES REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23065927 ↗MalfunctionSep 5, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
IT WAS REPORTED THAT DURING THE PROCEDURE, THE END OF THE PRODUCT CRUMPLED AND DOES NOT GO IN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO KNOWN PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22982321 ↗MalfunctionAug 26, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE STENT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22897499 ↗MalfunctionAug 4, 2025Break; Break
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 HAD COMPLETED THE PROCEDURE AND THERE WERE NO KNOWN PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22708483 ↗MalfunctionJul 31, 2025Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING THE PREPARATION, AFTER UNPACKING, BEFORE USE, WHEN IT WAS PULLED, IT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22682682 ↗MalfunctionJul 3, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT DURING THE PREPARATION PRIOR TO PROCEDURE, THE PHYSICIAN OPENED A TRIA STENT AND HE OBSERVED THE DEVICE WAS KINKED. THE PROCEDURE WAS RESCHEDULED AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22401118 ↗MalfunctionJun 16, 2025Break; Break
IT WAS REPORTED THAT A TRIA URETERAL STENT WAS TO BE USED IN A PROCEDURE. DURING PREPARATION, WHEN THE SUTURE WAS PULLED, THE STENT GOT SEPARATED. 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 22216236 ↗MalfunctionApr 28, 2025Break; Break
IT WAS REPORTED THAT DURING THE PREPARATION, WHILE REMOVING THE SUTURE FROM THE STENT PRIOR TO PLACING IT IN THE PATIENT, IT CAUSED THE END OF THE STENT TO SNAP/BREAK OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21921956 ↗MalfunctionApr 22, 2025Break; Break
IT WAS REPORTED THAT A TRIA URETERAL STENT WAS USED IN A PROCEDURE. DURING THE PROCEDURE, IT WAS NOTICED 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 21879054 ↗MalfunctionMar 21, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING PREPARATION, AFTER REMOVING THE PACKAGING, THE STENT WAS BROKEN WHEN THE THREAD WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THE PATIENT CONDITION WAS REPORTED TO BE STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21665693 ↗
Other Boston Scientific Corporation products
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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