Polaris™ Ultra M0061921240Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729124344), received between Mar 12, 2019 and May 22, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionMay 22, 2026Material Deformation

  IT WAS REPORTED THAT A POLARIS ULTRA URETERAL SENT WAS USED IN A RETROGRADE INTRARENAL SURGERY (RIRS) PROCEDURE. DURING THE PROCEDURE, IT WAS NOTICED THAT THE END OF THE STENT WAS DIFFERENT FROM THE ORIGINAL SHAPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME MODEL AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25260063 ↗
• MalfunctionApr 14, 2026Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT A POLARIS ULTRA URETERAL STENT WAS USED IN A URETEROSCOPY PROCEDURE IN THE KIDNEY. DURING THE PROCEDURE, THE STENT WAS NOT GOING OVER THE WIRE AND IT WAS NOTICED THAT IT WAS BUCKLING AT THE URETERAL OPENING. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24868488 ↗
• MalfunctionApr 6, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA URETERAL STENT WAS USED DURING AN UNKNOWN PROCEDURE, PERFORMED ON (B)(6), 2021. DURING THE PROCEDURE, WHEN THE PHYSICIAN TRIED TO INSERT THE POLARIS ULTRA STENT, THE STENT BROKE. THE PHYSICIAN TRIED SEVERAL TIMES WITH STENT SHEATH CONTINUOUSLY BREAKING. NO FURTHER INFORMATION WAS REPORTED IF A NEW STENT WAS USED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THERE WAS A MINOR INJURY TO PATIENT OR STAFF. NO TREATMENT WAS REPORTED TO THE PATIENT OR STAFF. ** ADDITIONAL INFORMATION RECEIVED ON (B)(6), 2021 ** 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: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11622967 ↗
• MalfunctionMar 12, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA STENT WAS TO BE USED IN A URETEROSCOPY (URS) PROCEDURE TO BE PERFORMED IN THE URETER, ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, OUTSIDE THE PATIENT, IT WAS NOTICED THAT THE STENT WAS BROKEN AT THE MIDDLE PART OF THE STENT. THIS WAS NOTICED WHILE THE DEVICE WAS STILL IN ITS PACKAGING.THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8414919 ↗