Polaris™ Ultra M006192133090Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729124450), received between Nov 14, 2017 and Sep 22, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Deformation Due to Compressive Stress; Difficult to Advance

  It was reported that a Polaris Ultra Ureteral stent was used in a Flexible Ureteroscopy procedure in the kidney. During insertion, the stent would not advance through the guidewire, and it was noticed that the stent was crumpled. 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 50856103 ↗
• MalfunctionJul 29, 2024Defective Device; Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Defective Device; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING THE PROCEDURE USING A POLARIS ULTRA STENT, IT WAS NOTICED THAT THE STENT WAS FOUND DAMAGED. ANOTHER OF THE SAME STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19857607 ↗
• MalfunctionOct 25, 2023Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT A POLARIS ULTRA URETERAL STENT WAS USED DURING A URETEROSCOPY PROCEDURE TO TREAT STONES IN THE URETER PERFORMED ON (B)(6) 2023. DURING INSERTION, THEY HAD DIFFICULTY PASSING THE STENT THROUGH THE GUIDEWIRE AND THE STENT WAS FOUND KINKED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER POLARIS ULTRA URETERAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18002634 ↗
• MalfunctionOct 14, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA URETERAL STENT WAS USED DURING A STENT REPLACEMENT PROCEDURE IN THE URETER, PERFORMED ON (B)(6), 2022. DURING THE PROCEDURE, IT WAS NOTED THAT THE STENT SHAFT WAS DETACHED OR SEPARATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER POLARIS ULTRA URETERAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15611286 ↗
• MalfunctionJun 27, 2022Material 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 A URETERAL STENT IMPLANTATION PROCEDURE IN THE URETER, PERFORMED ON (B)(6) 2022. AFTER THE PROCEDURE, WHEN THE PHYSICIAN DEPLOYED THE STENT, IT WAS NOTICED UNDER A CYSTOSCOPE THAT THE PIGTAIL WAS TORN. THE STENT WAS REMOVED AND ANOTHER POLARIS ULTRA URETERAL STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14835343 ↗
• MalfunctionMay 28, 2021Break; Detachment of Device or Device Component; Device-Device Incompatibility; Break; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA URETERAL STENT WITH .035IN DF SENSOR WAS USED DURING A TRANSURETHRAL LITHOTRIPSY FOR THE LEFT SIDE PROCEDURE PERFORMED ON (B)(6) 2021. IT WAS REPORTED THAT THE GUIDEWIRE BECAME SEPARATED DUE TO LASER RADIATION. PHOTOS OF THE COMPLAINT DEVICE SHOWED THAT THE CORE WIRE WAS BROKEN. 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. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11901201 ↗
• MalfunctionNov 14, 2017Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA STENT WAS USED IN THE URETER DURING A URETERAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTED THAT THE STENT WAS SEPARATED INTO TWO FROM THE CENTER. THE PROCEDURE WAS COMPLETED WITH OF THE SAME DEVICE. 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 Consequences Or Impact To Patient

  MAUDE report 7030418 ↗