Polaris™ Ultra M0061921530Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729720942), received between Jun 10, 2021 and Feb 11, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2025Deformation Due to Compressive Stress; Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Deformation Due to Compressive Stress; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING PROCEDURE, WHEN THE STENT WAS PUSHED UP USING THE POSITIONER, THE TAIL WAS BUCKLED. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21358503 ↗
• MalfunctionOct 20, 2023Deformation Due to Compressive Stress; Difficult to Advance; Material Split, Cut or Torn; Deformation Due to Compressive Stress; Difficult to Advance; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA URETERAL STENT WAS USED DURING A URETEROSCOPY PROCEDURE IN THE RIGHT URETER PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE STENT WAS PUSHED UP AS USING POSITIONER, THE PIGTAIL WAS BUCKLED, AND THEY FAILED TO INSERT IT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER POLARIS ULTRA URETERAL STENT. 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 GOOD. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THAT THE STENT WAS BUCKLED AND TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17980719 ↗
• MalfunctionJun 10, 2021Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA URETERAL STENT WAS USED DURING A URETERAL STENTING PROCEDURE IN THE RIGHT URETER, PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE AND INSIDE THE PATIENT, WHEN THE PHYSICIAN ATTEMPTED TO INSERT THE STENT, RESISTANCE WAS FELT AND THERE WAS DIFFICULTY IN ADVANCING STENT. ANOTHER POLARIS ULTRA URETERAL STENT USED TO SUCCESSFULLY COMPLETED THE PROCEDURE. 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 GOOD. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF STENT SHAFT BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11979468 ↗