Polaris™ Loop M0061552230Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 08714729421030), received between Jun 1, 2020 and Sep 9, 2026 — classified as 1 injury, 19 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 16, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Break

  It was reported that a Polaris Loop Ureteral stent was to be used in Left ureteral 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 50682404 ↗
• MalfunctionFeb 4, 2026Break; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING PREPARATION FOR A URETEROLITHOTOMY PROCEDURE, A POLARIS URETERAL STENT WAS FOUND TO BE TORN, WITH THE STENT SHAFT BROKEN, PRIOR TO USE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24260352 ↗
• MalfunctionJan 6, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A POLARIS LOOP URETERAL STENT WAS TO BE USED IN A URETEROSCOPIC STENT PLACEMENT PROCEDURE. DURING UNPACKING, A FLOCCULENT WAS FOUND ON THE STENT. 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 23981064 ↗
• MalfunctionJan 5, 2026Break

  IT WAS REPORTED THAT A POLARIS LOOP URETERAL STENT WAS TO BE USED IN A HOLMIUM LASER LITHOTRIPSY PROCEDURE. DURING UNPACKING, IT WAS FOUND THAT THE STENT WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. PICTURE PROVIDED BY THE CUSTOMER SHOWED THAT THE STENT SHAFT WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23970333 ↗
• MalfunctionNov 20, 2025Nonstandard Device; Material Split, Cut or Torn; Nonstandard Device; Material Split, Cut or Torn

  IT WAS REPORTED THAT A POLARIS LOOP URETERAL STENT WAS USED IN A LASER LITHOTRIPSY IN THE LEFT URETER. DURING THE PROCEDURE, IT WAS NOTICED THAT THE FISHTAIL COIL 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 23605895 ↗
• MalfunctionJul 25, 2025Calcified; Nonstandard Device; Difficult to Advance; Calcified; Difficult to Advance

  IT WAS REPORTED THAT A POLARIS LOOP URETERAL STENT WAS USED IN A URETERAL LITHOTRIPSY AND STONE REMOVAL IN THE URETER. DURING THE PROCEDURE, WHEN THE STENT WAS INSERTED, IT COULD NOT CROSS THE STENOSIS OF THE URETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED THAT THE STENT WAS CALCIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22611928 ↗
• MalfunctionNov 12, 2024Break; Break

  IT WAS REPORTED THAT DURING UNPACKING THE POLARIS LOOP URETERAL STENT, PRIOR TO THE URETEROSCOPIC LITHOTRIPSY PROCEDURE, THE FISHTAIL 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 20665718 ↗
• MalfunctionJul 25, 2024Detachment 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 DURING THE PROCEDURE, THE STENT FRACTURED WHEN IT WAS PUSHED OUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE AND NO PATIENT COMPLICATIONS REPORTED. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. INVESTIGATION RESULTS REVEALED THAT THE STENT SHAFT WAS BROKEN, THEREFORE THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19834079 ↗
• MalfunctionJul 9, 2024Break; Break

  IT WAS REPORTED THAT A POLARIS LOOP STENT WAS USED DURING A URETERAL LITHOTRIPSY PROCEDURE, IT WAS NOTICED THAT DURING UNPACKING THE STENT SHAFT WAS BROKEN INTO TWO PIECES ALONG THE SHAFT. ANOTHER OF THE SAME STENT 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 19707436 ↗
• MalfunctionMay 21, 2024Deformation Due to Compressive Stress; Difficult to Advance; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT DURING A FLEXIBLE URETEROSCOPE PROCEDURE, THE STENT HAD DIFFICULTY ADVANCING. IT WAS NOTED THAT THERE WAS A BLOCKAGE AND FOUND THAT THE STENT WAS BUCKLED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME STENT AND 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 19361754 ↗
• MalfunctionApr 18, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS LOOP URETERAL STENT WAS USED DURING A URETERAL LITHOTOMY PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2024. DURING PREPARATION, WHEN THE DEVICE WAS UNPACKED, 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 DISTAL END OF THE STENT SHAFT WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19134715 ↗
• MalfunctionJun 8, 2023Deformation Due to Compressive Stress; Material Split, Cut or Torn; Deformation Due to Compressive Stress; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS LOOP URETERAL STENT WAS USED DURING A URETERAL STENT PLACEMENT PROCEDURE IN THE URETER, PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE AND INSIDE THE PATIENT, IT WAS NOTICED THAT THE STENT CRACKED AT THE TAIL END PROBABLY CAUSED BY URETERAL STONES. ANOTHER POLARIS LOOP URETERAL STENT WAS OPENED AND 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. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THAT THE STENT WAS BUCKLED AND TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17085334 ↗
• MalfunctionMar 14, 2023Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS LOOP URETERAL STENT WAS GOING TO BE USED DURING A URETERAL CALCULUS PROCEDURE, PERFORMED ON (B)(6) 2023. DURING PREPARATION, WHILE THE DEVICE WAS UNPACKED, IT WAS FOUND THAT THE STENT WAS FRACTURED. ANOTHER POLARIS LOOP URETERAL STENT WAS OPENED AND 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16541821 ↗
• MalfunctionFeb 9, 2023Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS LOOP URETERAL STENT WAS USED DURING A LITHOTRIPSY BY FLEXIBLE URETEROSCOPY PROCEDURE IN THE LEFT URETER PERFORMED ON (B)(6) 2023. DURING UNPACKING, IT WAS FOUND THAT THE DEVICE 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 16334256 ↗
• InjuryNov 8, 2022Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS LOOP URETERAL STENT WAS USED DURING A URETERAL STENT PLACEMENT PROCEDURE IN THE RIGHT URETER, PERFORMED ON (B)(6), 2022. THE PATIENT HAD RIGHT URETERAL STENOSIS. IN ORDER TO REMOVE UPPER URINARY TRACT OBSTRUCTION, PROTECT RENAL FUNCTION AND ALLEVIATE CLINICAL SYMPTOMS, RIGHT URETERAL STENT REPLACEMENT WAS PERFORMED UNDER LOCAL ANESTHESIA. ON (B)(6), 2022, IT WAS NOTED THAT THE PATIENT HAD EXPERIENCED RIGHT WRIST PAIN, FELT UNCOMFORTABLE AND PAIN AFTER THE STENT INSERTION. THE PATIENT WAS TOLD TO DRINK MORE WATER AND WAS GIVEN A MEDICATION OF DICLOFENAC SODIUM 50MG ORALLY, TWICE A DAY. IT WAS REPORTED THAT THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM AT ANOTHER TIME TO HAVE THE STENT EXCHANGED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A DIFFERENT SIZE OF POLARIS LOOP URETERAL STENT. THE CONDITION OF THE PATIENT AFTER THREE DAYS WAS REPORTED RELIEVED.

  Patient problems: Discomfort; Pain

  MAUDE report 15756305 ↗
• MalfunctionOct 14, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS LOOP URETERAL STENT WAS USED DURING A LITHOTRIPSY PROCEDURE IN THE KIDNEY, PERFORMED ON (B)(6) 2022. DURING PREPARATION, IT WAS FOUND THAT THE BODY OF THE STENT WAS DAMAGED. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15609994 ↗
• MalfunctionOct 6, 2022Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS LOOP URETERAL STENT WAS USED DURING A URETERAL INTERVENTION PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, IT WAS NOTED THAT AFTER PLACEMENT, THE STENT BECAME KINKED AND BENT. 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 15553351 ↗
• MalfunctionSep 9, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS LOOP URETERAL STENT WAS USED DURING A URETEROSCOPY LITHOTRIPSY PROCEDURE IN THE URETHRA, PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, WHILE UNPACKING, THE PHYSICIAN NOTICED A HAIR INSIDE THE PACKAGE. THE HAIR WAS TAKEN OUT OF THE PACKAGE AND THE DEVICE COULD NOT BE USED. 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10511802 ↗
• MalfunctionJul 6, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A URETERAL POLARIS LOOP STENT WAS GOING TO BE USED FOR URETERAL STENT IMPLANTATION PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, OUTSIDE THE PATIENT, DURING THE INTRODUCTION OF THE DEVICE, WHEN THE PHYSICIAN INSERTED THE GUIDEWIRE ONTO THE STENT, THE STENT WAS FRACTURED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER URETERAL POLARIS LOOP 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 Consequences Or Impact To Patient

  MAUDE report 10234259 ↗
• MalfunctionJun 1, 2020Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS LOOP URETERAL STENT WAS USED DURING A URETERAL STENT IMPLANTATION PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, WHEN THE PHYSICIAN UNPACKED THE POLARIS LOOP URETERAL STENT, THE STENT SHAFT WAS FOUND TO BE 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10106213 ↗