Polaris™ Ultra M0061921550Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729124726), received between Jan 9, 2023 and Mar 7, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 7, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING INSERTION, WHEN THE STENT WAS PUSHED UP USING AS POSITIONER, THE TAIL WAS BUCKED AND FAILED TO INSERT IT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21549852 ↗
• MalfunctionSep 6, 2023Deformation Due to Compressive Stress; Difficult to Advance; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A POLARIS ULTRA URETERAL STENT WAS USED DURING A URETEROSCOPY PROCEDURE IN THE RIGHT URETER PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, WHEN ATTEMPTED TO INSERT THE STENT USING THE POSITIONER, THE TAIL BUCKLED, AND IT FAILED TO INSERT. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17688271 ↗
• MalfunctionMar 10, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA URETERAL STENT WAS USED DURING AN ANGIOGRAPHY PROCEDURE IN THE RIGHT URETER PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, IT WAS NOTED THAT WHEN THEY TRIED TO REMOVE THE SUTURE, THE COIL OF THE STENT WAS HURT. 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 DISTAL END OF THE STENT WAS RIPPED/TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16525863 ↗
• MalfunctionJan 9, 2023Difficult to Advance; Material Deformation; Material Split, Cut or Torn; Difficult to Advance; Material Deformation; 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 DECEMBER 15, 2022. DURING THE PROCEDURE AND INSIDE THE PATIENT, WHEN THE STENT WAS INSERTED, IT WAS NOTICED THAT THE STENT WAS CRUSHED AND FAILED TO DEPLOY. ANOTHER POLARIS ULTRA URETERAL STENT WAS OPENED AND 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16125430 ↗