Polaris™ Loop M0061552320Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 08714729421085), received between Jul 28, 2017 and Sep 18, 2026 — classified as 1 death, 2 injuries, 44 malfunctions.

The most frequently reported specific device problem is “Break” (22 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Break

  It was reported that a polaris loop ureteral stent was used during bilateral transurethral ureteral/kidney pelvis laser lithotripsy. During preparation, it was found that the double J catheter was fractured. 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 50819544 ↗
• MalfunctionSep 14, 2026Material Split, Cut or Torn

  It was reported that a Polaris Loop Ureteral stent was used in a Retrograde Intrarenal Surgery (RIRS) procedure. During the procedure and inside the patient, it was noticed that the stent was broken. 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 stable.A photo of the complaint device was provided and showed that the stent loops were broken.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50756334 ↗
• MalfunctionApr 22, 2026Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT A POLARIS LOOP URETERAL STENT WAS USED IN A RIGID URETEROSCOPIC LITHOTRIPSY PROCEDURE IN THE RIGHT RENAL PELVIS. DURING INSERTION AND INSIDE THE PATIENT, IT WAS NOTICED THAT THE STENT WAS STUCK. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE. PICTURE PROVIDED BY THE CUSTOMER SHOWED THAT THE STENT WAS BUCKLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24956094 ↗
• MalfunctionMar 3, 2026Material Integrity Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT A POLARIS LOOP URETERAL STENT WAS USED IN A URETEROSCOPIC LITHOTRIPSY PROCEDURE. DURING THE PROCEDURE AND INSIDE THE PATIENT, IT WAS NOTICED THAT THE SUTURE THREAD WAS ENTANGLED TO THE LOOP, CAUSING IT TO BREAK WHEN IT WAS UNTIED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24492970 ↗
• MalfunctionDec 2, 2025Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT, DURING THE URETEROSCOPY LITHOTRIPSY PROCEDURE RESISTANCE WAS ENCOUNTERED UPON INSERTION OF A POLARIS LOOP URETERAL STENT. THE DEVICE BECAME BLOCKED UPON REACHING THE URETER AND COULD NOT BE ADVANCED FURTHER. THE STENT WAS REMOVED AND FOUND TO BE DEFORMED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SAME POLARIS LOOP URETERAL STENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23701077 ↗
• MalfunctionNov 6, 2025Defective Device; Material Integrity Problem; Material Split, Cut or Torn; Defective Device; Material Integrity Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT A POLARIS LOOP URETERAL STENT WAS USED IN A URETEROSCOPIC LITHOTRIPSY PROCEDURE. DURING THE PROCEDURE WHILE IN THE PATIENT, THE LOOP WAS ENTANGLED TO THE SUTURE STRING CAUSING IT TO BREAK WHEN BEING UNTIED. 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 23490436 ↗
• MalfunctionOct 21, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT A POLARIS LOOP URETERAL STENT WAS USED IN A TRANSURETHRAL CYSTOSCOPIC LASER LITHOTRIPSY PROCEDURE IN THE URETER. DURING THE PROCEDURE, IT WAS NOTICED THAT THE STENT GOT BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. ADDITIONAL INFORMATION RECEIVED ON DECEMBER 07, 2025, CLARIFIED THAT, THE COIL WAS DETACHED. THEREFORE, THIS IS CONSIDERED NON REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23354023 ↗
• MalfunctionOct 20, 2025Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS REPORTED THAT A POLARIS LOOP URETERAL STENT WAS TO BE USED IN A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE. DURING UNPACKING, IT WAS FOUND THAT 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 23336667 ↗
• MalfunctionJul 15, 2025Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A POLARIS LOOP URETERAL STENT WAS USED IN A HARD URETEROSCOPIC LITHOTOMY PROCEDURE. DURING UNPACKING, IT WAS FOUND THAT THE STENT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. INVESTIGATION OF THE RETURNED DEVICE REVEALED THAT THE STENT SHAFT WAS DETACHED/SEPARATED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22516344 ↗
• MalfunctionJul 1, 2025Defective Device; Material Split, Cut or Torn; Defective Device; Material Split, Cut or Torn

  IT WAS REPORTED THAT A POLARIS LOOP URETERAL STENT WAS USED IN A URETEROSCOPIC LITHOTRIPSY (URSL) PROCEDURE. DURING THE PROCEDURE AND INSIDE THE PATIENT, THE LOOPS WERE ENTANGLED WITH THE SUTURE THREAD, CAUSING THE LOOPS TO BREAK WHEN UNTIED. 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 22373134 ↗
• MalfunctionMay 19, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT A POLARIS LOOP URETERAL STENT WAS USED DURING A URETEROSCOPIC LITHOTRIPSY PROCEDURE IN THE UPPER URETER. DURING THE PROCEDURE, THE LOOPS OF THE STENT WERE FRACTURED WHEN IT WAS INSERTED A LITTLE. 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 22047995 ↗
• MalfunctionMay 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE DOCTOR WAS ABOUT TO PLACE THE DJ INSIDE THE PATIENT'S BODY, BUT AFTER THE PLACEMENT, HE FOUND THAT THE COIL AT THE END WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21971951 ↗
• MalfunctionJan 8, 2025Break; Break

  IT WAS REPORTED THAT A POLARIS LOOP URETERAL STENT WAS TO BE USED DURING A LITHOTRIPSY PROCEDURE, AND, DURING UNPACKING, 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21106910 ↗
• MalfunctionNov 12, 2024Break; Break

  IT WAS REPORTED THAT DURING PREPARATION, PRIOR TO FLEXIBLE URETEROSCOPIC LITHOTRIPSY PROCEDURE, THE POLARIS LOOP URETERAL STENT WAS FOUND FRACTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20667888 ↗
• MalfunctionNov 30, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS LOOP URETERAL STENT WAS USED DURING A URETERAL LITHOTOMY UNDER RIGID ENDOSCOPE PROCEDURE IN THE URETER PERFORMED ON (B)(3) 2023. DURING PREPARATION, WHEN THE DEVICE WAS UNPACKED, IT WAS NOTED THAT THE STENT WAS FRACTURED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER POLARIS LOOP 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 18238881 ↗
• InjuryNov 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A POLARIS LOOP URETERAL STENT WAS SUCCESSFULLY IMPLANTED IN THE URETER DURING A URETERAL LITHOTRIPSY PROCEDURE FOR A URETERAL STONE REMOVAL ON (B)(6) 2023. PRIOR TO DISCHARGE, THE PATIENT EXPERIENCED ADVERSE REACTIONS SUCH AS UNCOMFORTABLE HEMATURIA. THE DEVICE WAS REMOVED AFTER THE UNBEARABLE PAIN. THERE WAS NO MEDICATION GIVEN TO THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER OF 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 STABLE.

  Patient problems: Hematuria; Pain

  MAUDE report 18098529 ↗
• MalfunctionSep 22, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS LOOP URETERAL STENT WAS ATTEMPTED TO BE USED DURING A LITHOTRIPSY VIA URETEROSCOPE PROCEDURE FOR THE TREATMENT OF STONES IN THE RIGHT KIDNEY PERFORMED ON (B)(6) 2023. DURING UNPACKING, THE STENT WAS FOUND FRACTURED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER POLARIS LOOP 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 17804329 ↗
• MalfunctionSep 20, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS LOOP URETERAL STENT WAS USED DURING A LITHOTRIPSY VIA URETEROSCOPE PROCEDURE FOR TREATMENT OF STONES IN THE UPPER PART OF THE LEFT URETER PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, INSIDE THE PATIENT, THE STENT WAS FOUND FRACTURED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER POLARIS LOOP 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 17782351 ↗
• MalfunctionJul 13, 2023Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS LOOP URETERAL STENT WAS USED DURING A FLEXIBLE URETEROSCOPE LITHOTRIPSY PROCEDURE IN THE RIGHT KIDNEY STONE, PERFORMED ON (B)(6) 2023. DURING PREPARATION, THE TAIL END OF THE STENT WAS FRACTURED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER POLARIS LOOP URETERAL STENT 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. INVESTIGATION RESULTS REVEALED THAT THE STENT WAS DETACHED/SEPARATED, THEREFORE THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17321874 ↗
• MalfunctionMar 3, 2023Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn

  IT WAS REPORTED TO THAT A POLARIS LOOP URETERAL STENT WAS USED DURING A TRANSURETEROSCOPIC LITHOTRIPSY PROCEDURE IN THE LEFT URETERAL CALCULI PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, INSIDE THE PATIENT, IT WAS NOTED THAT THE COIL BECAME FRACTURED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER POLARIS LOOP 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 DISTAL END OF THE STENT WAS TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16478481 ↗
• MalfunctionFeb 28, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS LOOP URETERAL STENT WAS USED DURING A TRANS URETERAL SOFT LITHOTRIPSY PROCEDURE IN THE RIGHT KIDNEY PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, OUTSIDE THE PATIENT, IT WAS NOTED THAT THE STENT WAS FRACTURED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER POLARIS LOOP 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 16450639 ↗
• MalfunctionJan 19, 2023Break; Break

  IT WAS REPORTED THAT A POLARIS LOOP URETERAL STENT WAS USED DURING A URETEROSCOPIC LITHOTRIPSY PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2022. DURING THE PREPARATION, IT WAS NOTED THAT THE DEVICE WAS FOUND DAMAGED AND COULD NOT BE USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER POLARIS LOOP 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. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF STENT SHAFT BROKEN. PLEASE SEE ADDITIONAL MFR. NARRATIVE FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16206736 ↗
• MalfunctionJan 18, 2023Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT A POLARIS LOOP URETERAL STENT WAS USED DURING A RIGID URETEROSCOPY LITHOTOMY PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, IT WAS NOTED THAT THE STENT COULD NOT CROSS THE LESION. IT WAS FOUND THAT THE STENT BECAME FRACTURED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER POLARIS LOOP 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. ADDITIONAL INFORMATION RECEIVED THAT THE FRACTURED WAS FOUND DURING UNPACKING AND OCCURRED OUTSIDE THE PATIENT. IT WAS NOTED THAT THE DEVICE COULD NOT BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16195805 ↗
• MalfunctionDec 8, 2022Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS LOOP URETERAL STENT WAS USED DURING A LITHOTRIPSY BY URETEROSCOPE PROCEDURE IN THE UPPER URETERAL CALCULI PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, IT WAS FOUND THAT THE LOWER END OF THE STENT WAS DEFORMED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME POLARIS LOOP 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 15940896 ↗
• MalfunctionDec 2, 2022Calcified; Device Stenosis; Calcified; Device Stenosis

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS LOOP URETERAL STENT WAS USED DURING A URETERAL STENT REPLACEMENT PROCEDURE IN THE KIDNEY, URETER AND BLADDER PERFORMED ON (B)(6) 2022. ON (B)(6) 2022, IT WAS NOTED THAT THE PATIENT HAD A FOLLOW UP APPOINTMENT, AND IT WAS FOUND THAT THE KIDNEY, URETER AND BLADDER SHOW HYDRONEPHROSIS. IT WAS REPORTED THAT AFTER THE LITHOTRIPSY TREATMENT, THE LITTLE CRUSHED STONE WAS SUPPOSED TO DRAINED THROUGH STENT OR URINE, BUT THE STONE CANT PASS THROUGH THE AND BLOCKED AT THE END OF THE STENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER POLARIS LOOP URETERAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENTS CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 15908667 ↗