Polaris™ Ultra M0061921420Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 08714729124542), received between Mar 2, 2017 and Feb 7, 2024 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Calcified” (7 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2024Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA URETERAL STENT WAS USED TO TREAT KIDNEY STONES DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE IN THE LEFT URETER PERFORMED ON (B)(6) 2024. DURING INSERTION, IT WAS NOTED THAT AT THE END OF THE PROCEDURE, WHEN THE STENT WAS INSERTED AND PUSHED, IT WAS FOUND KINKED. 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 18661598 ↗
• MalfunctionMar 15, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A POLARIS ULTRA URETERAL STENT WAS USED DURING A RETROGRADE INTRARENAL SURGERY PROCEDURE, PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE AND INSIDE THE PATIENT, WHEN THE PHYSICIAN PULLED BACK THE SUTURE FOR STENT DEPLOYMENT, IT WAS NOTICED THAT THE COIL OF THE STENT WAS BROKEN. ANOTHER POLARIS ULTRA URETERAL STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. 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 SHAFT BROKEN.

  MAUDE report 13766426 ↗
• InjuryFeb 10, 2022Adverse Event Without Identified Device or Use Problem; 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 URETERONEPHROSCOPY PROCEDURE IN THE RIGHT KIDNEY, BLADDER, PERFORMED ON (B)(6) 2021. POST PROCEDURE, ON (B)(6) 2022, THE PATIENT EXPERIENCED PAIN ON THE RIGHT SIDE DURING URINATION. THE PHYSICIAN INDICATED THAT THE PATIENT IS EXPERIENCING , "A REFLUX OF URINE FROM THE BLADDER TO THE RIGHT KIDNEY CAUSED BY THE NORMAL PROCESS OF THE BLADDER TO CLOSE WHEN IT IS GOING TO BE EMPTIED AND CAN NOT BE DONE BECAUSE THE STENT KEEPS THE HOLE ALWAYS OPEN TO FACILITATE DRAINAGE OF THE KIDNEY. WHEN THE REFLUX HAPPENS IT CAUSES THE PAIN THAT THE PATIENT REMITS". ENANTYUN PLUS, MODIFICAL, AND MEDICINE FOR BLADDER CONTRACTIONS WERE GIVEN TO THE PATIENT AS TREATMENT FOR PAIN. THE PATIENT'S PAIN IS BEGINNING TO DECREASE. THE POLARIS URETERAL STENT REMAINS IMPLANTED IN THE PATIENT. IT WAS ALSO REPORTED THAT, THE DIAGNOSIS OF PAIN WAS RELATED TO DEFECTS ON THE PATIENT'S RENAL SYSTEM AND THE PATIENT WILL BE OPERATED TO REMOVE THE LEFT KIDNEY AND ALSO TO REMOVE THE STENT FROM THE RIGHT URETER.

  Patient problems: Pain

  MAUDE report 13509987 ↗
• MalfunctionDec 16, 2021Difficult 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 CENCER PROCEDURE IN THE URETER, PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE STENT WAS DIFFICULT TO INSERT HROUGH THE GUIDEWIRE AND IT WAS NOTICED THAT THE INNER HOLE OF THE STENT WAS KINKED. ANOTHER POLARIS ULTRA URETERAL STENT WAS OPENED AND SUCCESSFULLY COMPLETED 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. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THAT ONE OF THE END OF THE STENT COIL WAS KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13020557 ↗
• MalfunctionSep 9, 2021Defective Device; Defective Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA URETERAL STENT WAS USED DURING A RETROGRADE INTRARENAL SURGERY PROCEDURE, PERFORMED ON (B)(6) 2021. DURING INTRODUCTION AND INSIDE THE PATIENT, IT WAS NOTICED THAT THE WHITE PART OF THE STENT DOES NOT ENTER BECAUSE IT DOES NOT RECEIVE POWER. ANOTHER POLARIS ULTRA URETERAL STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. 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. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF STENT SUTURE HOLE TORN INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12448916 ↗
• MalfunctionNov 10, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA URETERAL STENT WAS OPENED TO BE USED DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, OUTSIDE THE PATIENT, THE STENT WAS FOUND TO BE BROKEN ALONG THE SHAFT. 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 Consequences Or Impact To Patient

  MAUDE report 10819308 ↗
• MalfunctionApr 18, 2018Calcified; Calcified

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA STENT WAS REMOVED DURING A CATHETER REMOVAL PROCEDURE PERFORMED IN THE URETER ON (B)(6) 2018. THE STENT HAD BEEN PREVIOUSLY IMPLANTED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN NOTICED THAT THE STENT WAS CALCIFIED INSIDE THE PATIENT. THE CALCIFICATION WAS BROKEN UP THROUGH THE USE OF LASER, AND THE STENT WAS REMOVED IN ITS ENTIRETY. 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 7441064 ↗
• MalfunctionDec 14, 2017Calcified; Calcified

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS¿ ULTRA STENT WAS REMOVED FROM THE URETER IN A SCHEDULED CATHETER REMOVAL PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, IT WAS FOUND THAT THE STENT WAS CALCIFIED. THE ENTIRE STENT WAS REMOVED WITH THE USE OF A CLAMP. 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 7119351 ↗
• MalfunctionAug 16, 2017Calcified; Calcified

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS¿ ULTRA URETERAL STENT HAD BEEN IMPLANTED IN THE URETER ON (B)(6) 2017, AND WAS REMOVED ON (B)(6) 2017 AS A PLANNED URETEROSCOPY PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING STENT WITHDRAWAL, IT WAS NOTED THAT THE STENT WAS CALCIFIED AND WAS UNABLE TO DRAIN. A CLAMP WAS USED TO REMOVE THE ENTIRE STENT. 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 6798875 ↗
• MalfunctionAug 16, 2017Calcified; Calcified

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA URETERAL STENT HAD BEEN IMPLANTED IN THE URETER ON (B)(6) 2017 AND WAS REMOVED ON (B)(6) 2017 AS A PLANNED URETEROSCOPY PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING STENT WITHDRAWAL, IT WAS NOTED THAT THE STENT WAS CALCIFIED AND WAS UNABLE TO DRAIN. A CLAMP WITH THE AID OF CYSTOSCOPY WAS USED TO REMOVE THE ENTIRE STENT. 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 6798845 ↗
• MalfunctionAug 16, 2017Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA STENT WAS TO BE USED IN AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTICED THAT THE STENT WAS BROKEN IN HALF. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6798840 ↗
• MalfunctionAug 16, 2017Calcified; Calcified

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA URETERAL STENT HAD BEEN IMPLANTED IN THE URETHERS ON (B)(6) 2016, AND WAS REMOVED ON (B)(6) 2017 AS A PLANNED URETEROSCOPY PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING STENT WITHDRAWAL, IT WAS NOTED THAT THE STENT WAS CALCIFIED. A CLAMP WAS USED TO REMOVE THE STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME 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 ¿STABLE¿.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6798613 ↗
• MalfunctionMar 9, 2017Calcified; Calcified

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS¿ ULTRA URETERAL STENT WAS IMPLANTED IN THE URETER ON (B)(6) 2016 AND WAS REMOVED DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING STENT WITHDRAWAL, THE STENT WAS NOTED TO BE CALCIFIED. 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 6393224 ↗
• MalfunctionMar 2, 2017Calcified; Calcified

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS¿ ULTRA URETERAL STENT WAS IMPLANTED IN THE URETER ON (B)(6) 2016 AND WAS REMOVED DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING STENT WITHDRAWAL, THE STENT WAS NOTED TO BE CALCIFIED. 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 6373081 ↗