Polaris™ Ultra M0061921330Recalls & reported problems

Summary

The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 08714729124443), received between Jan 24, 2017 and Aug 4, 2026 — classified as 9 injuries, 62 malfunctions.

The most frequently reported specific device problem is “Break” (43 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 71 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2026Break

  It was reported that a Polaris Ultra ureteral stent was intended for use during a Retrograde Intrarenal Surgery (RIRS) procedure. Upon opening the package and prior to use, the device was found to be broken in the middle. The procedure was completed with another of the same device. There were no patient complications reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50125458 ↗
• MalfunctionMay 22, 2026Break

  IT WAS REPORTED THAT A POLARIS ULTRA URETERAL STENT WAS TO BE USED IN A LITHOTRIPSY PROCEDURE IN THE URETER. 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 25263120 ↗
• MalfunctionApr 15, 2026Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT A POLARIS ULTRA URETERAL STENT WAS TO BE USED IN A LITHOTOMY 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 24880945 ↗
• MalfunctionMar 23, 2026Break

  IT WAS REPORTED THAT A POLARIS ULTRA URETERAL STENT WAS TO BE USED IN A URETERAL STENT IMPLANTATION 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 24670519 ↗
• InjuryMar 3, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A POLARIS ULTRA URETERAL STENT WAS IMPLANTED INTO A PATIENT DURING A FLEXIBLE URETEROSCOPIC LITHOTRIPSY PROCEDURE IN THE KIDNEY. TWO WEEKS FOLLOWING THE PROCEDURE, IT WAS FOUND THAT THE STENT WAS FRACTURED IN THE MIDDLE PART AND WAS LEFT IN THE PATIENT'S BODY. THE FRACTURED PIECE WAS REMOVED AND ANOTHER OF THE SAME DEVICE SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24493054 ↗
• MalfunctionJan 22, 2026Break; Nonstandard Device

  IT WAS REPORTED THAT A POLARIS ULTRA URETERAL STENT WAS TO BE USED IN A RIGHT-SIDED URETERAL STENT REPLACEMENT PROCEDURE. DURING UNPACKING, IT WAS FOUND THAT THE DEVICE WAS FRACTURED. 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 24153147 ↗
• InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A POLARIS ULTRA URETERAL STENT WAS IMPLANTED INTO THE PATIENT'S RIGHT URETER DURING A LASER RESECTION OF RIGHT URETERAL LESION VIA URETHRA, HOLMIUM LASER LITHOTRIPSY OF THE RIGHT URETERAL ORIFICE VIA URETHRA, AND PLACEMENT OF A RIGHT URETERAL STENT VIA URETHRA PROCEDURE. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED RIGHT-SIDE AND LOWER BACK PAIN, URINARY URGENCY AND RECURRENT FREQUENT URINATION. ON (B)(6) 2025, THE PATIENT WAS ADMITTED TO THE HOSPITAL, AND URINALYSIS SHOWED HEMATURIA AND SEVERE URINARY TRACT INFECTION. A MEDICATION OF CEFTAZIDIME FOR ANTI-INFECTION AND INTRAVENOUS FLUID SUPPORT WAS GIVEN TO THE PATIENT. THERE WERE NO OTHER PATIENT COMPLICATIONS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON DECEMBER 10, 2025, STATING THAT, THE ONSET DATE OF PAIN, URINARY FREQUENCY AND URGENCY WAS ON (B)(6) 2025. THE STENT WAS REMOVED ON (B)(6) 2025, AND A NEW STENT OF THE SAME MODEL WAS REPLACED. THE ADVERSE EVENTS WERE REPORTED TO HAVE BEEN RESOLVED AND THE CURRENT CONDITION OF THE PATIENT IS STABLE. THERE WERE NO ISSUES NOTED INTO THE DEVICE AND, IN THE PHYSICIAN'S ASSESSMENT, PAIN, URINARY FREQUENCY AND URGENCY, AND UTI IS NOT RELATED TO THE DEVICE.

  Patient problems: Hematuria; Micturition Urgency; Pain; Urinary Frequency / Polyuria; Urinary Tract Infection

  MAUDE report 23840114 ↗
• MalfunctionOct 30, 2025Difficult to Advance; Material Split, Cut or Torn; Difficult to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT A POLARIS ULTRA URETERAL STENT WAS USED IN A URETEROSCOPY WITH LASER LITHOTRIPSY PROCEDURE IN THE BLADDER. DURING THE PROCEDURE, WHEN ATTEMPTING TO DEPLOY THE STENT, IT GOT STUCK ON THE GUIDEWIRE, CAUSING THE STENT TO DISINTEGRATE AND RIP. 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 23423755 ↗
• MalfunctionSep 18, 2025Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS REPORTED THAT A POLARIS ULTRA URETERAL STENT WAS USED IN A PROCEDURE. DURING THE PROCEDURE, IT WAS NOTICED THAT THE STENT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. ADDITIONAL INFORMATION WITH A PHOTO PROVIDED ON SEPTEMBER 18, 2025, SHOWED THAT THE STENT WAS TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23089711 ↗
• MalfunctionSep 17, 2025Break; Break

  IT WAS REPORTED DURING PREPARATION, UPON 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 23077852 ↗
• MalfunctionJul 7, 2025Deformation Due to Compressive Stress; Difficult to Advance; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT A POLARIS ULTRA URETERAL STENT WAS USED IN A TRANSURETHRAL STENT PLACEMENT PROCEDURE. DURING THE PROCEDURE, THE FRONT-END COIL ROLLED UP AND COULD NOT ADVANCE ANY FURTHER. 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 22424285 ↗
• MalfunctionJul 1, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PREPARATION, WHEN THE PACKAGE WAS OPENED AND IT WAS PUT ON THE TABLE, IT WAS FRACTURED WITHOUT FORCE WHEN THE WIRE WAS PULLED. 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 22374655 ↗
• MalfunctionMay 7, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING PROCEDURE, WHEN THE STENT WAS TAKEN OUT, IT WAS FOUND THAT THE COIL OF THE TAIL WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21976075 ↗
• MalfunctionApr 11, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT A POLARIS ULTRA URETERAL STENT WAS USED IN A PROCEDURE. DURING THE PROCEDURE, THE STENT WAS FRACTURED. 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 21830976 ↗
• MalfunctionOct 17, 2024Break; Break

  DURING UNPACKING, IT WAS NOTED THAT THE STENT WAS FOUND FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME STENT AND THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20476649 ↗
• MalfunctionOct 2, 2024Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT, DURING THE URETERAL LITHOTOMY PROCEDURE USING A POLARIS ULTRA URETERAL STENT, WHEN THE URETERAL STENT WAS PLACED USING THE GUIDE WIRE, THE GUIDE WIRE WAS STUCK AND COULD NOT BE WITHDRAWN SMOOTHLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20350142 ↗
• InjuryJul 10, 2024Break; Break

  IT WAS REPORTED THAT THE STENT WAS BROKEN INTO TWO PIECES ALONG THE SHAFT. THE BROKEN STENT WAS REMOVED FROM THE PATIENT. ANOTHER OF THE SAME STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19716627 ↗
• InjuryJul 10, 2024Break; Break

  IT WAS REPORTED THAT THE STENT WAS BROKEN INTO TWO PIECES ALONG THE SHAFT. THE BROKEN STENT WAS REMOVED FROM THE PATIENT. ANOTHER OF THE SAME STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19716333 ↗
• InjuryJul 10, 2024Break; Break

  IT WAS REPORTED THAT THE STENT WAS BROKEN INTO TWO PIECES ALONG THE SHAFT. THE BROKEN STENT WAS REMOVED FROM THE PATIENT. ANOTHER OF THE SAME STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19713422 ↗
• MalfunctionJun 24, 2024Break; Break

  IT WAS REPORTED THAT, DURING A URETERAL DILATATION PROCEDURE, USING A POLARIS ULTRA URETERAL STENT, WHEN THE STENT WAS UNPACKED, IT WAS NOTICED THAT THE STENT WAS BROKEN ALONG THE SHAFT. ANOTHER DIFFERENT STENT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19602386 ↗
• MalfunctionApr 11, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA URETERAL STENT WAS USED TO TREAT URETERAL CALCULI DURING A HOLMIUM LASER LITHOTRIPSY PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2024. DURING UNPACKING, THE DEVICE WAS FOUND FRACTURED. IT WAS NOTED THAT THE STENT WAS BROKEN INTO TWO PIECES 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. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19093817 ↗
• MalfunctionMar 25, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA URETERAL STENT WAS USED DURING A URETEROSCOPY PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2023. DURING PREPARATION, THE STENT WAS FOUND DISCONNECTED. IT WAS NOTED THAT THE STENT COIL PART WAS SNAPPED OR CUT INTO 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. INVESTIGATION RESULTS REVEALED THAT THE STENT WAS DETACHED, THEREFORE THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18968737 ↗
• MalfunctionFeb 2, 2024Break; Deformation Due to Compressive Stress; Break; Deformation Due to Compressive Stress

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA URETERAL STENT WAS USED TO TREAT KIDNEY STONES DURING A URETEROSCOPY PROCEDURE IN THE URINARY TRACT, UTERUS AND URETHRA. THE PROCEDURE DATE WAS NOR REPORTED. DURING THE PROCEDURE, THERE WAS A DEVICE MALFUNCTION. IT WAS NOTED THAT THE STENT 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 BROKEN AND BUCKLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18636870 ↗
• MalfunctionDec 22, 2023Break; Break

  NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT. IT WAS REPORTED THAT TWO URETERAL POLARIS ULTRA STENTS WERE ATTEMPTED TO BE USED DURING A STENT PLACEMENT PROCEDURE FOR KIDNEY STONE MANAGEMENT. THE EXACT EVENT DATE WAS UNKNOWN. DURING UNPACKING, IT WAS FOUND THAT THE TWO STENTS WERE FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER POLARIS ULTRA STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18381356 ↗
• MalfunctionDec 21, 2023Break; Break

  NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO URETERAL POLARIS ULTRA STENTS WERE ATTEMPTED TO BE USED DURING A STENT PLACEMENT PROCEDURE FOR KIDNEY STONE MANAGEMENT. THE EXACT EVENT DATE WAS UNKNOWN. DURING UNPACKING, IT WAS FOUND THAT THE TWO STENTS WERE FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER POLARIS ULTRA STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18379516 ↗