Polaris™ Ultra M0061921220Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 08714729124306), received between Feb 16, 2018 and Apr 11, 2026 — classified as 1 injury, 19 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 11, 2026Obstruction of Flow; Difficult to Advance

  It was reported that during a Ureteroscopy intervention procedure, a Polaris Ultra Ureteral stent was intended to be used. During preparation, it was found that the indwelling was unsuccessful and the lumen was blocked. 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 24852615 ↗
• MalfunctionJun 17, 2025Break; Break

  IT WAS REPORTED THAT A POLARIS ULTRA STENT WAS TO BE USED IN A STONE PROCEDURE FOR THE KIDNEY. DURING UNPACKING, IT WAS FOUND THAT THE STENT WAS FRACTURED ALONG THE SHAFT. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22249604 ↗
• MalfunctionMar 28, 2025Break; Break

  IT WAS REPORTED THAT POLARIS ULTRA URETERAL STENT WAS TO BE USED DURING A POSTERIOR EXENTERATION AND LOW ANTERIOR RESECTION OF THE RECTUM PROCEDURE. DURING PREPARATION, WHILE ATTEMPTING TO REMOVE THE SUTURE, THE STENT BROKE INTO THREE PARTS. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21727008 ↗
• MalfunctionJan 8, 2025Break; Break

  IT WAS REPORTED THAT DURING UNPACKING, WHEN THE PACKAGE WAS OPENED, THE STENT WAS FOUND FRACTURED. THE URETEROSCOPIC LITHOTOMY PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21108169 ↗
• MalfunctionSep 11, 2024Break; Break

  IT WAS REPORTED THAT A POLARIS ULTRA URETERAL STENT WAS GOING TO BE USED; HOWEVER, THE STENT WAS FOUND BROKEN UPON UNPACKING. ANOTHER OF THE SAME STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20189811 ↗
• MalfunctionMar 13, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA URETERAL STENT WAS USED DURING STENT INSERTION PROCEDURE IN THE POSTERIOR EXENTERATION, AND LOW ANTERIOR RESECTION OF THE RECTUM PERFORMED ON (B)(6) 2024. DURING INSERTION, WHEN THE SUTURE WAS REMOVED, IT WAS NOTED THAT THE STENT WAS BROKEN INTO THREE PIECES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER POLARIS ULTRA URETERAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THAT THE STENT SHAFT WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18899367 ↗
• MalfunctionDec 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA URETERAL STENT WAS USED DURING A URETEROSCOPIC LITHOTRIPSY PROCEDURE IN THE RIGHT URETER PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE END COIL WAS DAMAGED. IT WAS NOTED THAT THE COIL WAS DETACHED FROM THE STENT. 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 STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18379144 ↗
• MalfunctionDec 21, 2023Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA URETERAL STENT WAS USED DURING A URETEROSCOPIC LITHOTRIPSY PROCEDURE IN THE LEFT URETER PERFORMED ON (B)(6), 2023. DURING THE PROCEDURE, WHEN THE PUSHER WAS PUSHED, THE TAIL END WAS FOUND DEFORMED. 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 STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18378864 ↗
• MalfunctionSep 26, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA URETERAL STENT WAS USED DURING A HOLMIUM LASER LITHOTRIPSY PROCEDURE UNDER FLEXIBLE URETEROSCOPE IN THE RIGHT URETER FOR RIGHT KIDNEY STONES TREATMENT PERFORMED ON (B)(6) 2023. DURING PREPARATION, THE STENT WAS FRACTURED. IT WAS NOTED THAT THE STENT SHAFT WAS BROKEN INTO TWO PIECES. 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 STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17821618 ↗
• MalfunctionFeb 27, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS LOOP URETERAL STENT WAS USED DURING A LITHOTRIPSY BY FLEXIBLE URETEROSCOPY PROCEDURE IN THE LEFT URETER PERFORMED ON (B)(6) 2023. DURING UNPACKING, IT WAS FOUND THAT THE MIDDLE PART OF THE STENT WAS FRACTURED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER POLARIS LOOP 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 STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16448694 ↗
• MalfunctionFeb 16, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS LOOP URETERAL STENT WAS INTENDED TO BE USED IN A STENT PLACEMENT PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2023. DURING UNPACKING, IT WAS FOUND THAT THE STENT SHAFT WAS BROKEN BEFORE IT WAS LOADED ONTO THE WIRE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A POLARIS LOOP URETERAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16387564 ↗
• MalfunctionOct 14, 2022Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA URETERAL STENT WAS USED DURING A STONE PROCEDURE, PERFORMED ON (B)(6)2022. DURING THE PROCEDURE, WHEN THE STENT WAS INSERTED, THE SUTURE WIRE BROKE. WHEN THE STENT WAS REMOVED, IT WAS NOTICED THAT THE STENT WAS CRACKED. THE STENT WAS FULLY REMOVED FROM THE PATIENT. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED, BUT THERE WAS NO INFORMATION ON WHAT COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15611198 ↗
• MalfunctionMar 3, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA URETERAL STENT WAS USED A URETEROSCOPY PROCEDURE IN THE BLADDER PERFORMED ON (B)(6), 2022. DURING THE PROCEDURE, WHEN ATTEMPTED TO PLACE THE POLARIS ULTRA URETERAL STENT, IT WAS FOUND THAT THE SUTURE TORN OUT A PORTION OF THE POLARIS ULTRA URETERAL STENT. 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 FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13660878 ↗
• MalfunctionApr 13, 2021Deformation Due to Compressive Stress; Material Split, Cut or Torn; Deformation Due to Compressive Stress; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA URETERAL STENT WAS USED DURING A URETEROSCOPIC LITHOTRIPSY PROCEDURE IN THE URETER PERFORMED ON MARCH 22, 2021. DURING THE PROCEDURE, INSIDE THE PATIENT, WHEN THE PHYSICIAN TRIED TO ADVANCE THE PUSHER INTO THE URETER, THE DISTAL END OF THE STENT WAS RIPPED/TORN AND BUCKLED. 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 AND BUCKLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11655760 ↗
• MalfunctionMar 17, 2021Deformation Due to Compressive Stress; Device-Device Incompatibility; Material Deformation; Deformation Due to Compressive Stress; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA URETERAL STENT WAS USED DURING A TRANSURETHRAL URETEROSCOPE LITHOTRIPSY PROCEDURE IN THE URETER, PERFORMED ON (B)(6) 2020. DURING THE PROCEDURE AND INSIDE THE PATIENT, WHEN THE PHYSICIAN ADVANCED THE PUSHER FROM THE BACK OF DOUBLE J, THE DOUBLE J WAS STUCK WITH THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF STENT BUCKLED/ACCORDION, STENT DEFORMED, AND GUIDEWIRE PIECE WAS STUCK INSIDE THE STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11506716 ↗
• MalfunctionAug 7, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA URETERAL STENT WAS USED DURING A URETEROLITHOTOMY PROCEDURE IN THE URETER, PERFORMED ON (B)(6), 2020. ACCORDING TO THE COMPLAINANT, DURING THE STENT PLACEMENT PROCEDURE, IT WAS NOTICED THAT THE DEVICE WAS FRACTURED WHEN REMOVING FROM THE PATIENT'S BODY. THE FRACTURED STENT WAS PULLED OUT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER 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 STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10379327 ↗
• MalfunctionDec 10, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A POLARIS ULTRA URETERAL STENT WAS USED DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT WHEN THE WIRE WAS REMOVED FROM THE STENT THE STENT BROKE IN HALF. 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 STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9446850 ↗
• MalfunctionJun 27, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA STENT WAS USED DURING A KIDNEY STONES REMOVAL SURGERY PROCEDURE IN THE KIDNEY, PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTICED THAT THE STENT WAS BROKEN ALONG THE SHAFT. THERE WAS NO SERIOUS INJURY, NOR WERE THERE ANY ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8739452 ↗
• InjuryJun 10, 2019Break; Calcified; Break; Calcified

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA STENT WAS REMOVED FROM THE URETER DURING A RIGID URETEROSCOPIC LITHOTOMY PROCEDURE IN THE URETER, PERFORMED ON (B)(6) 2019. ON (B)(6) 2019, POLARIS ULTRA STENT WAS IMPLANTED IN THE URETER. ACCORDING TO THE COMPLAINANT, DURING THE UNPLANNED STENT REMOVAL, IT WAS NOTICED ON A FLEXIBLE URETEROSCOPE THAT THE STENT WAS BROKEN INTO HALF ALONG THE SHAFT. THERE WAS NO SERIOUS INJURY, NOR WERE THERE ANY ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT. THE CONDITION OF THE PATIENT AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8684095 ↗
• MalfunctionFeb 16, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA URETERAL STENT WAS USED FOR A URETEROSCOPIC LITHOTRIPSY (URS) PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE UNPACKING, IT WAS NOTICED THAT THE STENT WAS DETACHED. THE PROCEDURE WAS 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 STABLE. THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED THAT THE STENT WAS BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7277176 ↗