Tria™ Firm M0061902230Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729937852), received between Mar 12, 2020 and Apr 1, 2026 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionJan 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A TRIA URETERAL STENT WAS USED DURING A URETEROSCOPY PROCEDURE, AND, DURING INSERTION IT WAS NOTICED THAT THE SUTURE HAD TORE THE STENT 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 21063745 ↗
• InjuryAug 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO DEVICES THAT WERE USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE TRIA FIRM URETERAL STENTS WERE USED DURING STENT PLACEMENT PROCEDURE IN THE LEFT AND RIGHT URETER FOR STONE MANAGEMENT, PERFORMED ON (B)(6) 2022 AS PART OF THE U0652 DOUBLE-J REGISTRY CLINICAL STUDY. ON (B)(6) 2022, THE TRIA FIRM URETERAL STENTS WERE SUCCESSFULLY IMPLANTED UNDER FLUOROSCOPY IN THE LEFT AND RIGHT URETER, AND THE PATIENT WAS PRESCRIBED THE DISCHARGE MEDICATIONS OF ACETAMINOPHEN (TYLENOL) , ALPHA BLOCKER, ANTICHOLINERGIC, NON STEROIDAL ANTI INFLAMMATORY DRUGS (NSAIDS), AND PHENAZOPYRIDINE. NO ISSUES WERE NOTED WITH THE DEVICES. DURING THE PLANNED STENT REMOVAL PERFORMED ON (B)(6) 2022, THE TRIA URETERAL STENTS WERE SUCCESSFULLY REMOVED FROM THE PATIENT WITHOUT ANY DIFFICULTY. THERE WERE NO NEW DEVICE IMPLANTED. THE PATIENTS CONDITION ON (B)(6) 2022 EXPERIENCED BILATERAL ACUTE PYELONEPHRITIS TO WORSENING URINARY RETENTION DUE TO ANESTHESIA. THE PATIENT WAS GIVEN FENTANYL FOR HER PAIN IV FLUIDS, ZOSYN AND FLOMAX. ON (B)(6) 2022 THE PATIENT HAD FOLEY PLACEMENT. ON (B)(6) 2022 THE EVENT WAS CONSIDERED RESOLVED. IN THE PHYSI

  Patient problems: Pain; Unspecified Infection; Urinary Retention

  MAUDE report 15237650 ↗
• InjuryAug 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO DEVICES THAT WERE USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE TRIA FIRM URETERAL STENTS WERE USED DURING STENT PLACEMENT PROCEDURE IN THE LEFT AND RIGHT URETER FOR STONE MANAGEMENT, PERFORMED ON (B)(6) 2022 AS PART OF THE U0652 DOUBLE-J REGISTRY CLINICAL STUDY. ON (B)(6) 2022, THE TRIA FIRM URETERAL STENTS WERE SUCCESSFULLY IMPLANTED UNDER FLUOROSCOPY IN THE LEFT AND RIGHT URETER, AND THE PATIENT WAS PRESCRIBED THE DISCHARGE MEDICATIONS OF ACETAMINOPHEN (TYLENOL), ALPHA BLOCKER, ANTICHOLINERGIC, NON STEROIDAL ANTI INFLAMMATORY DRUGS (NSAIDS), AND PHENAZOPYRIDINE. NO ISSUES WERE NOTED WITH THE DEVICES. DURING THE PLANNED STENT REMOVAL PERFORMED ON (B)(6) 2022, THE TRIA URETERAL STENTS WERE SUCCESSFULLY REMOVED FROM THE PATIENT WITHOUT ANY DIFFICULTY. THERE WERE NO NEW DEVICE IMPLANTED. THE PATIENTS CONDITION ON (B)(6) 2022 EXPERIENCED BILATERAL ACUTE PYELONEPHRITIS TO WORSENING URINARY RETENTION DUE TO ANESTHESIA. THE PATIENT WAS GIVEN FENTANYL FOR HER PAIN IV FLUIDS, ZOSYN AND FLOMAX. ON (B)(6) 2022 THE PATIENT HAD FOLEY PLACEMENT. ON (B)(6) 2022 THE EVENT WAS CONSIDERED RESOLVED. IN THE PHYSIC

  Patient problems: Pain; Unspecified Infection; Urinary Retention

  MAUDE report 15237646 ↗
• MalfunctionAug 5, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRIA FIRM URETERAL STENT WAS USED DURING A PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, IT WAS NOTED THAT WHEN THE STENT WAS INSERTED INSIDE THE PATENT AND TRIED TO REMOVE THE SUTURE, THE STENT GOT TORN, HOWEVER, THE STENT COULD BE PULLED BY SUTURE AND WAS SUCESSFULLY REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER TRIA FIRM URETERAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15175411 ↗
• MalfunctionOct 7, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PREVIOUSLY IMPLANTED TRIA FIRM URETERAL STENT WAS BEING REMOVED FROM A PATIENT DURING A STENT REMOVAL PROCEDURE IN THE BLADDER PERFORMED ON (B)(6) 2020. THE TRIA FIRM URETERAL STENT WAS IMPLANTED ABOUT TWO WEEKS PRIOR TO THE PLANNED STENT REMOVAL PROCEDURE PERFORMED ON (B)(6) 2020 WITH NO ISSUES REPORTED DURING PLACEMENT. HOWEVER, THE EXACT IMPLANT DATE WAS NOT REPORTED. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2020, DURING THE PLANNED STENT REMOVAL PROCEDURE, THE STENT WAS SLIPPING FROM THE GRASPER AND IT WAS DIFFICULT TO REMOVE. REPORTEDLY, AFTER SEVERAL ATTEMPTS THE PHYSICIAN WAS ABLE TO REMOVE THE STENT USING A FLEXIBLE GRASPER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10641251 ↗
• InjuryJul 9, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRIA FIRM URETERAL STENT WAS USED DURING A STENT EXCHANGE PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, INSIDE THE PATIENT, DURING THE PROCEDURE, WHEN THE PHYSICIAN WAS PUSHING UP THE STENT OVER A ZIP WIRE WITH A PUSHER FOR STENT PLACEMENT, THE COIL PART DETACHED FROM THE END OF THE STENT. THE BROKEN PIECE OF THE STENT WAS COMPLETELY REMOVED FROM THE PATIENT WITH A PAIR OF GRASPERS. REPORTEDLY, THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10251360 ↗
• MalfunctionMar 12, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRIA URETERAL STENT WAS OPENED FOR USE IN AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTICED THAT A FOREIGN MATTER THAT SEEMED TO BE HAIR WAS FOUND INSIDE THE STERILE BAG. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER TRIA URETERAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9824947 ↗