Polaris™ Ultra M0061921230Recalls & reported problems

Summary

The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 08714729124320), received between Apr 19, 2019 and Sep 30, 2026 — classified as 3 injuries, 59 malfunctions.

The most frequently reported specific device problem is “Break” (30 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 25 most recent of 62 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Difficult to Advance; Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949572 ↗
• MalfunctionSep 29, 2026Break

  It was reported that a Polaris Ultra Ureteral stent was used in a procedure. During the procedure, it was noticed that the stent was broken. There was no information on what have completed the procedure and there were no patient complications reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927893 ↗
• MalfunctionSep 9, 2026Break; Detachment of Device or Device Component

  It was reported that a Polaris Ultra Ureteral stent was to be used in a Lithotripsy procedure. During unpacking, it was found that the stent was fractured. 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 50684087 ↗
• MalfunctionMay 29, 2026Unsealed Device Packaging

  IT WAS REPORTED THAT A POLARIS ULTRA URETERAL STENT WAS USED IN A PROCEDURE. DURING THE PROCEDURE, IT WAS FOUND THAT THE STENT WAS CONTAMINATED. THERE WAS NO INFORMATION ON WHAT HAVE COMPLETED THE PROCEDURE AND THERE WERE NO KNOWN PATIENT COMPLICATIONS REPORTED. NOTE: THIS REPORT PERTAINS TO ONE OF THE FOUR POLARIS ULTRA URETERAL STENT USED IN THE SAME PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25331591 ↗
• MalfunctionMay 28, 2026Unsealed Device Packaging

  IT WAS REPORTED THAT A POLARIS ULTRA URETERAL STENT WAS USED IN A PROCEDURE. DURING THE PROCEDURE, IT WAS FOUND THAT THE STENT WAS CONTAMINATED. THERE WAS NO INFORMATION ON WHAT HAVE COMPLETED THE PROCEDURE AND THERE WERE NO KNOWN PATIENT COMPLICATIONS REPORTED. NOTE: THIS REPORT PERTAINS TO ONE OF THE FOUR POLARIS ULTRA URETERAL STENT USED IN THE SAME PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25325165 ↗
• MalfunctionMay 28, 2026Unsealed Device Packaging

  IT WAS REPORTED THAT A POLARIS ULTRA URETERAL STENT WAS USED IN A PROCEDURE. DURING THE PROCEDURE, IT WAS FOUND THAT THE STENT WAS CONTAMINATED. THERE WAS NO INFORMATION ON WHAT HAVE COMPLETED THE PROCEDURE AND THERE WERE NO KNOWN PATIENT COMPLICATIONS REPORTED. NOTE: THIS REPORT PERTAINS TO ONE OF THE FOUR POLARIS ULTRA URETERAL STENT USED IN THE SAME PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25325158 ↗
• MalfunctionMay 28, 2026Unsealed Device Packaging

  IT WAS REPORTED THAT A POLARIS ULTRA URETERAL STENT WAS USED IN A PROCEDURE. DURING THE PROCEDURE, IT WAS FOUND THAT THE STENT WAS CONTAMINATED. THERE WAS NO INFORMATION ON WHAT HAVE COMPLETED THE PROCEDURE AND THERE WERE NO KNOWN PATIENT COMPLICATIONS REPORTED. NOTE: THIS REPORT PERTAINS TO ONE OF THE FOUR POLARIS ULTRA URETERAL STENT USED IN THE SAME PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25322704 ↗
• MalfunctionApr 14, 2026Break

  IT WAS REPORTED THAT DURING A TRANSURETHRAL URETERAL STENTING PROCEDURE, A POLARIS ULTRA URETERAL STENT WAS TO BE USED. AFTER UNPACKING, IT WAS FOUND THAT THE DJ CATHETER WAS FRACTURED. 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 24872686 ↗
• MalfunctionApr 1, 2026Break

  IT WAS REPORTED THAT, DURING A URETEROSCOPY PROCEDURE, A POLARI ULTRA URETERAL STENT WAS INTENDED TO BE USED. WHEN THE PHYSICIAN OPENED THE PRODUCT, IT WAS FOUND THE MIDDLE PART OF THE URETERAL STENT WAS FRACTURED AND IT COULD NOT BE USED. 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 24751015 ↗
• MalfunctionMar 3, 2026Break; Nonstandard Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT A POLARIS ULTRA URETERAL STENT WAS TO BE USED IN A UROLOGICAL SURGERY PROCEDURE. DURING UNPACKING, IT WAS FOUND THAT THE STENT WAS FRACTURED. 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 24493056 ↗
• MalfunctionOct 1, 2025Break; Break

  IT WAS REPORTED THAT DURING UNPACKING, WHEN THE PACKAGE WAS OPENED IN PREPARATION FOR PROCEDURE, THE URETERAL STENT WAS FOUND TO BE 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 23193621 ↗
• MalfunctionSep 17, 2025Break; Break

  IT WAS REPORTED THAT DURING UNPACKING, IT WAS FOUND THAT THE DEVICE WAS FRACTURED AND COULD NOT BE USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23079486 ↗
• InjuryAug 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN IT WAS PUT INSIDE THE PATIENT, THE TIP WAS FRACTURED AND IT COULD NOT BE USED. 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 22895891 ↗
• MalfunctionMay 9, 2025Break; Break

  IT WAS REPORTED THAT DURING THE PREPARATION, AFTER UNPACKED, IT WAS FOUND THAT THE TUBE OF THE URETERAL STENT WAS FRACTURED. CONFIRMED VIA PHONE THAT THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS STABLE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21993687 ↗
• MalfunctionApr 11, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT A POLARIS ULTRA URETERAL STENT WAS USED IN A TRANSURETHRAL THULIUM LASER LITHOTRIPSY OF URETER PROCEDURE. DURING THE PROCEDURE AND INSIDE THE PATIENT, WHEN THE STENT WAS POSITIONED AND ADJUSTED, IT WAS NOTICED THAT THE STENT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DIFFERENT MODEL AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21828015 ↗
• MalfunctionJan 27, 2025Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE URETEROLITHIASIS PROCEDURE, THE BLUE END HAD A KINK MARK. 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 21246308 ↗
• MalfunctionNov 27, 2024Break; Defective Device; Material Split, Cut or Torn; Break; Defective Device; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING PREPARATION, THE POLARIS ULTRA URETERAL STENT WAS FOUND CREASED. IT WAS NOTICED AFTER BEING USED WITH THE GUIDEWIRE AND AFTER BEING PULLED, THE STENT WAS FOUND TO BE THINNER AND WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME STENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20800528 ↗
• MalfunctionNov 27, 2024Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE URETEROSCOPIC LITHOTRIPSY PROCEDURE, THE POLARIS ULTRA URETERAL STENT WAS FOUND WITH CREASES, INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20799362 ↗
• MalfunctionNov 21, 2024Break; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Break; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT, DURING A URETEROSCOPIC LITHOTRIPSY PROCEDURE USING A POLARIS ULTRA URETERAL STENT, THE STENT BODY WAS RUPTURED. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20748221 ↗
• MalfunctionSep 11, 2024Break; Break

  IT WAS REPORTED THAT, DURING KIDNEY STONE REMOVAL AND PLACEMENT OF STENT PROCEDURE A POLARIS ULTRA STENT WAS GOING TO BE USED, IT WAS OBSERVED THAT THE STENT SHAFT WAS BROKEN UPON UNPACKING. ANOTHER OF THE SAME STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20195055 ↗
• MalfunctionAug 12, 2024Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING A TRANSURETHERAL URETEROSCOPE LASER LITHOTRIPSY PROCEDURE USING A POLARIS ULTRA STENT, IT WAS NOTICED DURING PREPARATION THAT THE STENT WAS BROKEN INTO TWO PIECES ALONG THE SHAFT. ANOTHER OF THE SAME STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. THE CONDITION OF THE PATIENT AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19962754 ↗
• MalfunctionMay 23, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT, DURING A FLEXIBLE URETERAL ENDOSCOPIC PROCEDURE, THE FRONT END OF THE STENT BECAME BUCKLED. ANOTHER OF THE SAME DEVICE WAS USED TO SUCCESSFULLY COMPLETE 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 STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19387752 ↗
• MalfunctionMay 16, 2024Break; Break

  IT WAS REPORTED THAT DURING LITHOTRIPSY PROCEDURE, WHEN THE DEVICE WAS UNPACKED, THE STENT WAS FOUND TO BE FRACTURED. IT WAS NOTED THAT THE STENT WAS BROKEN INTO TWO PARTS. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME STENT AND 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 19330882 ↗
• MalfunctionMar 22, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA URETERAL STENT WAS USED DURING A URETERAL CATHETERIZATION PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTED THAT THE FRONT-END PART OF THE STENT WAS FOUND FRACTURED. 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. 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 18962020 ↗
• MalfunctionJan 18, 2024Material Deformation; 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 STENT WAS TRIED TO PUSH FOR INSERTION, THE STENT WAS 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 18540379 ↗