Polaris™ Ultra M0061921320Recalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 08714729124429), received between Dec 15, 2016 and Sep 18, 2026 — classified as 8 injuries, 56 malfunctions.

The most frequently reported specific device problem is “Break” (28 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 25 most recent of 64 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Nonstandard Device; Material Split, Cut or Torn

  It was reported that a polaris ultra was used during ureteroscopic lithotripsy. During procedure, it was found that there is a crack at the distal end of DJ stent. The procedure was completed with another of the same device. There were no patient complications as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50817244 ↗
• MalfunctionMay 7, 2026Break

  IT WAS REPORTED THAT A POLARIS ULTRA URETERAL STENT WAS TO BE USED IN A LITHOTRIPSY PROCEDURE. DURING UNPACKING, IT WAS FOUND THAT THE STENT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25108647 ↗
• MalfunctionApr 14, 2026Deformation Due to Compressive Stress

  IT WAS REPORTED THAT A POLARIS ULTRA URETERAL STENT WAS USED IN A LITHOTRIPSY PROCEDURE IN THE KIDNEY. DURING INTRODUCTION AND INSIDE THE PATIENT, IT WAS NOTICED THAT THE STENT WAS WRINKLED AND COULD NOT BE PUSHED IN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24876145 ↗
• InjuryMar 25, 2026Nonstandard Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT A POLARIS ULTRA URETERAL STENT WAS USED DURING A FLEXIBLE URETEROSCOPIC LITHOTRIPSY PROCEDURE IN THE KIDNEY. DURING THE PROCEDURE AND INSIDE THE PATIENT, IT WAS NOTICED THAT THE STENT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THAT THE COIL WAS DETACHED.THE BROKEN STENT WAS REMOVED FROM THE PATIENT WITH THE USE OF FORCEPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24688698 ↗
• MalfunctionDec 4, 2025Break; Nonstandard Device; Break; Nonstandard Device

  IT WAS REPORTED THAT A POLARIS ULTRA STENT WAS TO BE USED IN A PROCEDURE. DURING UNPACKING, IT WAS FOUND THAT THE STENT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23722490 ↗
• MalfunctionNov 19, 2025Break; Break

  IT WAS REPORTED THAT A POLARIS ULTRA URETERAL STENT WAS TO BE USED IN A URETEROLITHOTOMY PROCEDURE IN THE URETER. DURING THE PROCEDURE AND OUTSIDE THE PATIENT, IT WAS NOTICED THAT THE STENT WAS FRACTURED IN THE MIDDLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23600813 ↗
• MalfunctionOct 23, 2025Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT A POLARIS ULTRA URETERAL STENT WAS USED DURING A PROCEDURE. DURING THE PROCEDURE, THE STENT WAS DIFFICULT TO ADVANCE THROUGH THE GUIDEWIRE AND IT WAS NOTICED THAT THE STENT WAS BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23376007 ↗
• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THAT DURING UNPACKING, IT WAS FOUND THAT THE STENT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23295989 ↗
• MalfunctionAug 15, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ENDOSCOPIC URETEROLITHOTOMY PROCEDURE, WHILE ATTEMPTING TO INSERT A DOUBLE-J CATHETER, WE NOTICED A PROBLEM. THE DEVICE COMES WITH A PROTECTIVE PLASTIC COVER THAT MUST BE REMOVED BEFORE INSERTION. THIS PLASTIC WAS TANGLED WITH THE CATHETER WIRES, AND WHEN WE TRIED TO REMOVE IT, IT BROKE INTO TWO PIECES. THIS INCIDENT OCCURRED IN THE OPERATING ROOM DURING THE PROCEDURE. THE INTEGRITY OF THE PRODUCT WAS COMPROMISED DURING HANDLING PRIOR TO INSERTION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO KNOWN PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22821425 ↗
• MalfunctionJul 14, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE DISTAL END OF THE DOUBLE J STENT SHOWS AN ABNORMAL CURVATURE INSIDE THE PATIENT'S BLADDER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22503775 ↗
• MalfunctionJun 16, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE COTTON THREAD WAS ENTANGLED WITH THE DOUBLE J STENT AND THE STENT FRACTURED DURING THE REMOVAL OF THE THREAD. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22215684 ↗
• MalfunctionJan 17, 2025Deformation Due to Compressive Stress; Difficult to Advance; Material Split, Cut or Torn; Deformation Due to Compressive Stress; Difficult to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A URETEROLITHOTOMY PROCEDURE, A POLARIS ULTRA URETERAL STENT WAS USED, AND, WHEN THE DEVICE WAS INSERTED INTO THE URINARY MEATUS, THE GUIDEWIRE WAS NOT ABLE TO PASS THROUGH THE STENT. IT WAS NOTICED THAT THE STENT DID NOT UNFOLD, BECAME CORRUGATED, AND, WAS TORN. THE STENT WAS REMOVED AND ANOTHER OF THE SAME DEVICE SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21185780 ↗
• MalfunctionJan 15, 2025Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE DEVICE WAS FOUND TO BE DEFECTIVE AND SHOWED SIGNS OF DAMAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. ADDITIONAL INFORMATION WAS RECEIVED ON JANUARY 08, 2025, THAT THE STENT WAS TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21164070 ↗
• InjuryDec 10, 2024Calcified; Difficult to Remove; Calcified; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A POLARIS ULTRA URETERAL STENT REMOVAL IN (B)(6) 2024. SEVERAL PATIENTS' STENTS WERE CALCIFIED THEY ORIGINALLY WAS IMPLANTED IN (B)(6) 2024. REMOVAL OF THE DOUBLE CATHETER ALSO REQUIRED A LASER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20898164 ↗
• MalfunctionAug 8, 2024Defective Device; Adverse Event Without Identified Device or Use Problem; Defective Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHEN THE POLARIS ULTRA URETERAL STENT WAS USED IN A PROCEDURE, THE LOWER END OF THE STENT WAS DAMAGED. ANOTHER OF THE SAME STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19943062 ↗
• InjuryApr 5, 2024Deformation Due to Compressive Stress; Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Deformation Due to Compressive Stress; Difficult to Advance; 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 FLEXIBLE URETEROLITHOMY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT DID NOT PASS THROUGH THE GUIDEWIRE. IT WAS NOTED THAT THE STENT WAS BUCKLED. THE STENT WAS SOAKED IN WATER FOR APPROXIMATELY 5 TO 10 MINUTES, HOWEVER, DUE TO THE FAILURE TO PASS, IT HAD TO BE REMOVED. THE PROCEDURE HAD TO BE CANCELED BECAUSE THE PATIENT BECAME COMPLICATED, AND DISCOMFORT WAS EXPERIENCED. IT WAS NOTED THAT THE DISCOMFORT EXPERIENCED WAS FROM THE SPECIALISTS WITH THE PRODUCT PROBLEM. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Discomfort; Insufficient Information

  MAUDE report 19053008 ↗
• InjuryApr 4, 2024Deformation Due to Compressive Stress; Difficult to Advance; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA URETERAL STENT WAS USED DURING A FLEXIBLE URETEROLITHOTOMY PLUS CATHETER PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT DID NOT PASS THROUGH THE GUIDEWIRE. IT WAS NOTED THAT THE STENT WAS BUCKLED. THE STENT WAS SOAKED IN WATER FOR APPROXIMATELY 5 TO 10 MINUTES, HOWEVER, DUE TO THE FAILURE TO PASS, IT HAD TO BE REMOVED. THE PROCEDURE HAD TO BE CANCELED BECAUSE THE PATIENT WAS BLEEDING, AND DISCOMFORT WAS EXPERIENCED. A NEPHROSTOMY HAD TO BE PERFORMED FOR THE PATIENT'S BLEEDING. IT WAS NOTED THAT THE DISCOMFORT EXPERIENCED WAS FROM THE SPECIALISTS WITH THE PRODUCT PROBLEM. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Discomfort; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19047342 ↗
• InjuryApr 4, 2024Deformation Due to Compressive Stress; Difficult to Advance; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA URETERAL STENT WAS USED DURING A FLEXIBLE URETEROLITHOMY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT DID NOT PASS THROUGH THE GUIDEWIRE. IT WAS NOTED THAT THE STENT WAS BUCKLED. THE STENT WAS SOAKED IN WATER FOR APPROXIMATELY 5 TO 10 MINUTES, HOWEVER, DUE TO THE FAILURE TO PASS, IT HAD TO BE REMOVED. THE PROCEDURE HAD TO BE CANCELED BECAUSE THE PATIENT BECAME COMPLICATED, AND DISCOMFORT WAS EXPERIENCED. IT WAS NOTED THAT THE DISCOMFORT EXPERIENCED WAS FROM THE SPECIALISTS WITH THE PRODUCT PROBLEM. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Discomfort; Insufficient Information

  MAUDE report 19047095 ↗
• MalfunctionFeb 26, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA URETERAL STENT WAS OPENED TO BE USED DURING A URETEROLITHOTOMY PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2024. DURING INSERTION, WHEN THE DEVICE WAS UNPACKED, THE STENT WAS FOUND BROKEN IN TWO PIECES. 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 STABLE. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THAT THE STENT SHAFT WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18784913 ↗
• MalfunctionFeb 8, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA URETERAL STENT WAS OPENED TO BE USED TO TREAT KIDNEY STONED DURING A URETER LITHOTOMY PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2022. DURING PREPARATION, WHEN THE DEVICE WAS UNPACKED, THE STENT WAS FOUND BROKEN IN TWO PARTS. 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. 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 18673146 ↗
• MalfunctionOct 20, 2023Deformation Due to Compressive Stress; Difficult to Advance; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA URETERAL STENT WAS USED DURING A LEFT RENAL LITHOTRIPSY UNDER LEFT URETEROSCOPE PROCEDURE IN THE LEFT KIDNEY PERFORMED ON (B)(6). 2023. DURING THE PROCEDURE, WHEN THE FLEXIBLE ENDOSCOPE WAS COMPLETED, THE STENT COULD NOT BE IMPLANTED SMOOTHLY. IT WAS FOUND THAT THE BLADDER END OF THE STENT WAS FOLDED. 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 STABLE. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THAT THE STENT WAS BUCKLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17981113 ↗
• MalfunctionAug 29, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A POLARIS ULTRA URETERAL STENT WAS OPENED DURING A LITHOTRIPSY PROCEDURE TO BE USED IN THE URETER PERFORMED ON (B)(6), 2023. DURING PREPARATION, WHEN THE PACKAGE WAS OPENED, THE STENT SHAFT WAS FOUND BROKEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER POLARIS ULTRA URETERAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THAT THE STENT SHAFT WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17643396 ↗
• MalfunctionJun 28, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A POLARIS ULTRA URETERAL STENT WAS OPENED TO BE USED DURING A LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2023. DURING PREPARATION, IT WAS FOUND THAT THE STENT WAS BROKEN INTO TWO PIECES ALONG THE SHAFT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER POLARIS ULTRA URETERAL STENT DEVICE. 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 17221468 ↗
• MalfunctionJun 12, 2023Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A POLARIS ULTRA URETERAL STENT WAS OPENED TO BE USED DURING A URETEROSCOPE TITANIUM LASER LITHOTRIPSY FOR RIGHT RENAL CALCULUS PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2023. DURING UNPACKING, IT WAS FOUND THAT THE MID PART OF THE STENT WAS FRACTURED. 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 STABLE. 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 17109648 ↗
• MalfunctionJun 9, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA URETERAL STENT WAS USED DURING A URETEROSCOPY PROCEDURE IN THE COMMON BILE DUCT, PERFORMED ON (B)(6)2023. DURING THE PROCEDURE, WHEN THE STENT WAS ADVANCED FOR DEPLOYMENT, IT WAS NOTICED THAT THE STENT BUCKLED. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17100593 ↗