Polaris™ Ultra M0061921340Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729124467), received between May 24, 2017 and May 7, 2025 — classified as 1 injury, 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A POLARIS ULTRA URETERAL STENT WAS TO BE USED IN A URETEROSCOPY (URS) PROCEDURE. DURING UNPACKING, IT WAS FOUND THAT THE STENT WAS BROKEN. 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 21981432 ↗
• MalfunctionOct 25, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA URETERAL STENT WAS USED DURING A STONE PROCEDURE IN THE URETER, PERFORMED ON (B)(6) 2022. DURING UNPACKING, THE PHYSICIAN FOUND THE STENT FRACTURED. 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 STABLE. INVESTIGATION RESULTS REVEALED THE STENT SHAFT WAS DETACHED; THEREFORE, THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15670918 ↗
• InjurySep 3, 2021Adverse 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 CYSTO RETROGRADE PYELOGRAM, CYSTOSCOPY LEFT RETROGRADE URETEROGRAM WITH LEFT URETEROSCOPY AND LEFT DOUBLE J STENT PLACEMENT, URETEROSCOPY PROCEDURE IN THE LEFT URETER PERFORMED ON (B)(6) 2021. THE STENT WAS SUCCESSFULLY IMPLANTED WITHOUT ANY PROBLEMS. ON (B)(6) 2021, POST PROCEDURE, IT WAS NOTED THAT A HIGHLY RARE BACTERIA WAS DETECTED IN THE PATIENT'S URINE. IT WAS NOT CONFIRMED IF THE IMPLANTED STENT COULD BE AN UNDERLYING CONTRIBUTING FACTOR. A BACTERIA THAT GREW FROM URINE CULTURE WAS RAOULTELLA PLANTICOLA AND THE PATIENT WAS PLACED ON MACROBID. IT WAS REPORTED THAT THE PATIENT WAS GIVEN WITH ORAL ANTIBIOTICS BY COMMUNITY PHYSICIAN. THE STENT WAS SUCCESSFULLY REMOVED FROM THE PATIENT AT THE OTHER FACILITY AND THERE WERE NO NEW STENT IMPLANTED. THE PATIENT REMAINED AS AN OUTPATIENT AND STABLE.

  Patient problems: Unspecified Infection

  MAUDE report 12424507 ↗
• MalfunctionNov 19, 2020Difficult 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 URETERAL STENTING PROCEDURE IN THE RIGHT URETER, PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, INSIDE THE PATIENT, THE STENT COULD NOT BE INSERTED ALONG WITH THE PTFE GUIDEWIRE. THE PIGTAIL WAS DEFORMED BY THE PUSHER. 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 Consequences Or Impact To Patient

  MAUDE report 10868393 ↗
• MalfunctionSep 17, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA URETERAL STENT WAS USED DURING A URETEROSCOPIC LITHOTRIPSY (URS) PROCEDURE IN THE RIGHT URETER PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND INSIDE THE PATIENT, AFTER STENT INSERTION FAILURE, THE BLADDER COIL WAS TORN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER POLARIS ULTRA URETERAL STENT. THERE WERE NO PATIENT COMPLICATIONS AFTER 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 10547211 ↗
• MalfunctionJan 14, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A POLARIS ULTRA URETERAL STENT WAS OPENED FOR USE FOR A CYSTOSCOPY RETROGRADE PYELOGRAM PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, THE STENT BROKE AS THE PACKAGE WAS OPENED. THE PROCEDURE WAS COMPLETED WITH ANOTHER POLARIS ULTRA URETERAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9588832 ↗
• MalfunctionDec 3, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA STENT WAS TO BE USED FOR A URETEROSCOPY WITH STENT PLACEMENT PROCEDURE PERFORMED IN THE URETER ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, BEFORE THE STENT WAS INSERTED INTO THE PATIENT, THE STENT BROKE WHEN THEY ATTEMPTED TO REMOVE THE SUTURE FROM THE STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER POLARIS ULTRA STENT. THERE WERE NO SERIOUS INJURIES NOR WERE THERE ANY ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT. THE CONDITION OF THE PATIENT AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8127254 ↗
• MalfunctionDec 3, 2018Difficult to Remove; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT POLARIS ULTRA STENT WAS IMPLANTED IN THE URETER FOR A URETEROSCOPY STENT PLACEMENT PROCEDURE ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, POST PROCEDURE ON (B)(6) 2018, DURING THE PLANNED STENT REMOVAL TO BE COMPLETED WITH AN IN-OFFICE CYSTOSCOPY, THE PHYSICIAN HAD DIFFICULTY REMOVING THE STENT. THE PATIENT WAS REFERRED TO THE HOSPITAL TO HAVE A URETEROSCOPY TO REMOVE THE STENT. THE PHYSICIAN WAS ABLE TO DETERMINE THAT THE STENT HAD KINKED IN THE PROXIMAL COIL WHICH HAD PREVENTED IT FROM STRAIGHTENING OUT. THE ENTIRE STENT WAS REMOVED SUCCESSFULLY. NO ADDITIONAL STENT WAS PLACED. THERE WAS NO SERIOUS INJURY NOR WERE THERE ANY ADVERSE PATIENT EFFECTS AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8127070 ↗
• MalfunctionMay 24, 2017Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS¿ ULTRA URETERAL STENT WAS TO BE USED DURING A PROCEDURE ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, WHILE REMOVING THE STENT FROM PACKAGING, IT WAS NOTICED THAT THE STENT WAS BROKEN IN HALF. THE PROCEDURE WAS 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 6588247 ↗