Polaris™ Ultra M0061921310Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729124405), received between Dec 19, 2017 and Sep 23, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PREPARATION, WHEN THE PACKAGE WAS OPENED, THE POLARIS ULTRA URETERAL STENT WAS FOUND BROKEN. 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 20285800 ↗
• MalfunctionApr 15, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA URETERAL STENT WAS OPENED. THE EVENT DATE WAS NOT REPORTED. IT WAS REPORTED THAT WHEN THE DEVICE WAS UNPACKED, THE STENT WAS FOUND BROKEN. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. 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 19111428 ↗
• MalfunctionMar 23, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA URETERAL STENT WAS OPENED TO BE USED DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING PREPARATION. THE DEVICE TIP WAS FOUND STICKY. IT WAS NOTED THAT THE PACKAGING WAS NORMAL. 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 18965351 ↗
• MalfunctionFeb 14, 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 ENDOSCOPIC COMBINED INTRA RENAL SURGERY PROCEDURE IN THE URINARY TRACT PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, IT WAS NOTED THAT THE STENT COULD NOT BE INSERTED THROUGH TRANSURETHRAL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THAT THE STENT WAS BUCKLED, INSIDE THE PATIENT, THEREFORE THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16375899 ↗
• MalfunctionOct 14, 2022Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA URETERAL STENT WAS USED DURING A URETERAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. DURING WITHDRAWAL OF THE STENT PUSHER, THE RADIO OPAQUE (RO) MARKER BAND ATTACHED AT THE TIP OF THE STENT PUSHER FELL OFF. THE RO MARKER BAND GOT STUCK IN THE WORKING CHANNEL OF THE CYSTOSCOPE. AFTER THE PROCEDURE, THE RO MARKER BAND WAS ABLE TO BE REMOVED FROM THE SCOPE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15611144 ↗
• MalfunctionNov 23, 2020Break; Material Deformation; Break; Material Deformation

  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) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, OUTSIDE THE PATIENT, WHEN THE PHYSICIAN PULLED THE SUTURE FROM THE BLADDER COIL, IT WAS NOTICED THAT THE STENT SHAFT BROKE. ANOTHER POLARIS ULTRA STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED BY THE COMPLAINANT AND SHOWED THE COIL DEFORMED. 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 10885440 ↗
• MalfunctionNov 27, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA URETERAL STENT WAS USED DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, THE STENT SHAFT WAS FRACTURED WHILE THE STENT WAS BEING PLACED OVER THE GUIDEWIRE. 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9386442 ↗
• MalfunctionDec 19, 2017Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS¿ ULTRA STENT WAS TO BE IMPLANTED IN AN URETEROSCOPIC LITHOTRIPSY (URSL) PROCEDURE PERFORMED IN THE UTERINE ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE PHYSICIAN NOTED THAT THE STENT WAS BROKEN INTO TWO PIECES ALONG THE SHAFT. THIS DEVICE WAS NOT USED IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER POLARIS¿ ULTRA 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 7128927 ↗