Polaris™ Loop M0061552330Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 08714729421092), received between Sep 9, 2019 and Dec 2, 2025 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2025Break; Break

  IT WAS REPORTED THAT A POLARIS ULTRA URETERAL STENT WAS USED IN A URETERAL STENT BREAKAGE PROCEDURE. DURING THE PROCEDURE, 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23701030 ↗
• MalfunctionSep 5, 2025Break; Break

  IT WAS REPORTED THAT A POLARIS LOOP URETERAL STENT WAS TO BE USED IN A NEPHROURETEROSCOPIC LITHOTRIPSY PROCEDURE IN THE RENAL 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 22974905 ↗
• MalfunctionJul 23, 2025Break; Break

  IT WAS REPORTED THAT A POLARIS LOOP URETERAL STENT WAS TO BE USED IN A URETEROSCOPIC STENT IMPLANTATION 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 22583290 ↗
• MalfunctionMay 1, 2025Break; Break

  IT WAS REPORTED THAT DURING PREPARATION, WHEN UNPACKING AND TAKING OUT THE WIRE, THE STENT FRACTURED. A NEW ONE WAS TAKEN AND USED TO COMPLETE THE PROCEDURE. THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21944985 ↗
• MalfunctionApr 4, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING PREPARATION, THE STENT WAS FRACTURED INTO THREE PIECES. 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 21778509 ↗
• MalfunctionNov 12, 2024Break; Break

  IT WAS REPORTED THAT DURING THE PREPARATION FOR THE LASER LITHOTRIPSY PROCEDURE, THE DOUBLE COIL WAS FOUND FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. THE CONDITION OF THE PATIENT AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20667805 ↗
• MalfunctionJul 25, 2024Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT, DURING LASER LITHOTRIPSY PROCEDURE USING A POLARIS LOOP STENT, IT WAS NOTICED THAT DURING INSERTION THAT THE STENT WAS KINKED AND COULD NOT CROSS THE STENOSIS. A DIFFERENT DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. THE CONDITION OF THE PATIENT AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19829094 ↗
• MalfunctionJan 6, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS LOOP URETERAL STENT WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, 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. INVESTIGATION RESULTS REVEALED THAT 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 16117991 ↗
• MalfunctionNov 4, 2022Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS LOOP URETERAL STENT WAS USED DURING A URETEROSCOPIC ENDOPROSTHESIS PLACEMENT PROCEDURE IN THE LEFT URETER, PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE AND INSIDE THE PATIENT, IT WAS NOTED THAT THE STENT WAS BROKEN IN HALF ALONG THE SHAFT WHEN THE GUIDEWIRE WAS RETRACTED WHILE ATTEMPTING TO DEPLOY THE STENT. ANOTHER POLARIS LOOP URETERAL STENT WAS OPENED AND 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 15738570 ↗
• MalfunctionOct 14, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS LOOP URETERAL STENT WAS USED DURING A KIDNEY STONE PROCEDURE IN THE KIDNEY, PERFORMED ON (B)(6) 2022. DURING UNPACKING, IT WAS FOUND THAT THE STENT WAS FRACTURED. ANOTHER POLARIS LOOP 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 BROKEN; 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 15610936 ↗
• MalfunctionDec 14, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS LOOP URETERAL STENT WAS USED DURING A URINARY STONES WITH LITHOTRIPSY PROCEDURE IN THE RENAL PELVIS PERFORMED ON (B)(6) 2021. DURING UNPACKING, THE PHYSICIAN FOUND THAT THE TIP OF THE POLARIS LOOP URETERAL 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. INVESTIGATION RESULTS REVEALED THAT THE STENT SHAFT WAS BREAK, THEREFORE THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13007004 ↗
• MalfunctionAug 6, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS LOOP URETERAL STENT WAS USED DURING A URETEROLITHIASIS PROCEDURE IN THE URETER, PERFORMED ON (B)(6) 2020. DURING UNPACKING, IT WAS FOUND THAT THE STENT COIL WAS DETACHED. ANOTHER POLARIS LOOP 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. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF STENT SHAFT BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12288830 ↗
• MalfunctionJan 6, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS LOOP URETERAL STENT WAS USED IN A URETERAL STENT PLACEMENT PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND INSIDE THE PATIENT, IT WAS NOTICED THAT THE LOOPS WERE BROKEN RIGHT AFTER THE STENT WAS SUCCESSFULLY PLACED IN THE TARGET ANATOMY LOCATION. THIS RESULTED IN THE LOOPS BECOMING FOUR THREADS INSTEAD OF TWO LOOPS. THE TORN POLARIS LOOP URETERAL STENT REMAINED IMPLANTED IN THE PATIENT. 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 AND FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11123716 ↗
• MalfunctionJan 4, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PREVIOUSLY IMPLANTED POLARIS LOOP URETERAL STENT WAS REMOVED FROM A PATIENT DURING A URETERAL STENT REPLACEMENT PROCEDURE PERFORMED IN THE URETER. THE EXACT DATE OF THE PROCEDURE WAS NOT REPORTED. ON (B)(6) 2020, APPROXIMATELY ONE TO TWO MONTHS AFTER THE STENT WAS IMPLANTED, THE PHYSICIAN PERFORMED A PLANNED STENT REMOVAL PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN NOTICED THAT THE LOOPS OF THE POLARIS LOOP URETERAL STENT WERE BROKEN. THE STENT WAS REMOVED IN ITS ENTIRELY FROM THE PATIENT AND ANOTHER POLARIS LOOP URETERAL STENT WAS USED TO SUCCESSFULLY COMPLETE 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 AND FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11109182 ↗
• MalfunctionAug 6, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS LOOP URETERAL STENT WAS USED DURING A URETER STONE PROCEDURE IN THE URETER, PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, WHEN THE PHYSICIAN UNPACKED THE PACKAGE, IT WAS NOTICED THAT THE COIL WAS BROKEN. ANOTHER POLARIS LOOP 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. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; STENT SHAFT BREAK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10376424 ↗
• MalfunctionFeb 20, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS LOOP URETERAL STENT WAS TO BE USED IN A STENT PLACEMENT PROCEDURE IN THE URETER, PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PREPARATION, THE ASSISTANT PHYSICIAN GENTLY TOUCHED THE URETERAL STENT AND IT BECAME DETACHED. THE PHYSICIAN DECIDED TO USE ANOTHER POLARIS LOOP URETERAL STENT AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WAS NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS A RESULT OF THIS EVENT. 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 Consequences Or Impact To Patient

  MAUDE report 9734571 ↗
• MalfunctionOct 10, 2019Detachment 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 TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS LOOP STENT WAS USED DURING A URETERAL REPLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINT DURING THE PROCEDURE THE COIL WAS DETACHED AT THE END OF THE STENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND MODEL. 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 REPORTABLE BASED ON THE INVESTIGATION RESULTS; DISTAL SECTION (SHAFT STENT) DETACHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9175035 ↗
• MalfunctionSep 9, 2019Calcified; Difficult to Remove; Material Deformation; Calcified; Difficult to Remove; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS LOOP WAS USED DURING A PROCEDURE IN THE KIDNEY. THE EXACT IMPLANT DATE WAS NOT REPORTED, HOWEVER, THE STENT WAS IMPLANTED FOR APPROXIMATELY TWO WEEKS. ACCORDING TO THE COMPLAINANT, DURING A PLANNED STENT REMOVAL PROCEDURE ON (B)(6) 2019, IT WAS NOTICED THAT THE POLARIS LOOP WAS NOT IN A STRAIGHT SHAPE WHEN REMOVED, CAUSING DIFFICULTY REMOVING FROM THE PATIENT. THE STENT WAS REMOVED USING A GRASPING FORCEPS WITH LOCAL ANESTHESIA, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO SERIOUS INJURY, 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 STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8976913 ↗