Polaris™ Ultra M0061921350Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729124498), received between May 3, 2018 and Oct 2, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (4 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.

• MalfunctionOct 2, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE PREPARATION, THE STENT WAS ALREADY BROKEN WHEN THE PACKAGING WAS OPENED JUST BEFORE USE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO KNOWN PATIENT COMPLICATIONS REPORTED. NOTE: ADDITIONAL INFORMATION WAS RECEIVED FROM THE COMPLAINANT ON OCTOBER 16, 2025, THE REPORTED EVENT OF STENT COIL DETACHED OCCURRED OUTSIDE THE PATIENT. THEREFORE, THIS IS CONSIDERED NON-REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23197352 ↗
• MalfunctionAug 18, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING INSERTION, THE PHYSICIAN ATTEMPTED TO PLACE EACH POLARIS ULTRA URETERAL STENT, BUT THE COIL TIP WAS CRUMPLED AND MALFORMED. THE THIRD STENT ATTEMPTED AND COMPLETED WITH INSERTION JUST FINE. TWO SEPARATE LOTS, WITH THE SAME ISSUE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22830430 ↗
• MalfunctionAug 18, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING INSERTION, THE PHYSICIAN ATTEMPTED TO PLACE EACH POLARIS ULTRA URETERAL STENT, BUT THE COIL TIP WAS CRUMPLED AND MALFORMED. THE THIRD STENT ATTEMPTED AND COMPLETED WITH INSERTION JUST FINE. TWO SEPARATE LOTS, WITH THE SAME ISSUE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22829624 ↗
• MalfunctionFeb 7, 2024Deformation Due to Compressive Stress; Difficult to Advance; Deformation Due to Compressive Stress; Difficult to Advance

  NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR REPORT # 2124215-2024-04553 AND MFR. REPORT # 2124215-2024-04544). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA URETERAL STENT WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE STENT WAS ATTEMPTED TO PLACE OVER THE WIRE, BUT THEY COULD NOT GET IT THROUGH THE URETER. IT WAS NOTED THAT THE PATIENT HAD A VERY NARROW URETEROPELVIC JUNCTION AND THE STENT WAS FOUND BUCKLED. 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 18660326 ↗
• MalfunctionFeb 7, 2024Deformation Due to Compressive Stress; Difficult to Advance; Deformation Due to Compressive Stress; Difficult to Advance

  NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR REPORT # 2124215-2024-04553 AND MFR. REPORT # 2124215-2024-04544). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA URETERAL STENT WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE STENT WAS ATTEMPTED TO PLACE OVER THE WIRE, BUT THEY COULD NOT GET IT THROUGH THE URETER. IT WAS NOTED THAT THE PATIENT HAD A VERY NARROW URETEROPELVIC JUNCTION AND THE STENT WAS FOUND BUCKLED. 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 18660325 ↗
• MalfunctionJul 12, 2023Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA URETERAL STENT WAS USED DURING A URETEROSCOPY PROCEDURE, PERFORMED ON (B)(6), 2023. DURING THE PROCEDURE, WHEN THE STENT WAS PUSHED USING A POSITIONER, IT WAS NOTICED THAT THE TAIL OF THE STENT BUCKLED AND IT FAILED TO BE INSERTED. ANOTHER POLARIS ULTRA URETERAL STENT WAS OPENED AND 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 GOOD. ADDITIONAL INFORMATION RECEIVED ON JULY 19. 2023 STATING THAT THE TARGET ANATOMY LOCATION FOR THIS PROCEDURE WAS THE KIDNEY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17305631 ↗
• MalfunctionAug 18, 2021Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA URETERAL STENT WAS USED DURING A URETERAL STENTING PROCEDURE IN THE RIGHT URETER PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, WHEN THE PHYSICIAN PUSHED THE STENT USING THE POSITIONER, THE STENT COIL BECAME BUCKLED AND WAS UNABLE TO INSERT 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 GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12338803 ↗
• MalfunctionMay 3, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS¿ ULTRA STENT WAS TO BE USED FOR A PROCEDURE PERFORMED IN THE URETER ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, THE STENT WAS NOTICED TO BE BROKEN INTO TWO PIECES ALONG THE SHAFT INSIDE OF THE PACKAGING. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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 FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7485507 ↗